4.6.1
Admission, Transfer && Discharge
A. Each hospital shall have written
admission, transfer and discharge policies and procedures pertaining to at
least the following:
1. types of clinical
conditions acceptable for admission to specific levels of care and appropriate
clinical departments or services;
2. informing and offering advance directives
to all patients upon admission;
3.
constraints imposed by limitations of services, physical facilities or staff
coverage;
4. emergency
admissions;
5. requirements for
informed consent signed by patient or legal representatives for diagnostic and
treatment procedures;
6. internal
transfer of patients from one level or type of care to another;
7. discharge and termination of services;
and
8. provisions for a mechanism
for recording, transmitting patient-specific information to other health care
providers and receiving information essential to the continuity of patient
care. (This mechanism shall include the required use of the Department's
Continuity of Care form. See also §4.6.1(C)(3)(c) of this Part);
and
B. In addition to the
above policies in §4.6.1(A) of this Part each hospital shall adopt the
following:
1. no person shall be denied
admission to the hospital because of race, color, religion, ancestry, sexual
orientation, or national origin;
2.
every patient admitted to the hospital shall be and remain under the care of a
member of the medical staff as specified under the by-laws;
3. no suspected or actually infected
non-obstetric patient shall be admitted to the obstetric department or
unit;
4. transfer agreements or
contracts shall clearly delineate responsibilities of parties involved;
and
5. pursuant to R.I. Gen. Laws
§
23-17.14-15 not discourage persons who cannot afford to pay from seeking essential medical
services; and not encourage persons who cannot afford to pay to seek essential
medical services from other providers.
C. Discharge Planning
The hospital shall have a discharge planning process for
all inpatients. Discharge planning policies and procedures must be in writing
and shall include a mechanism for discharge planners to receive regular updates
regarding new offerings of community programs and the complete range of current
options available at discharge.
1.
The hospital shall identify, at an early stage in hospitalization, all
inpatients who are likely to suffer adverse health consequences on discharge if
there is no adequate discharge planning.
2. A discharge planning evaluation shall be
provided to all inpatients identified in §4.6.1(C)(1) of this Part above,
to other patients on patient request, the request of the person acting on the
patient's behalf, or upon the request of the physician.
a. The evaluation shall be timely to avoid
unnecessary delays in discharge and must be part of the patient's medical
record.
b. The evaluation shall
include a needs assessment, the patient's capacity for self-care, and the
availability of post-hospital services to meet the needs of the
patient.
c. A registered nurse or
social worker shall develop or supervise the development of the
evaluation.
d. The results of the
evaluation shall be discussed with the patient or the individual acting on the
patient's behalf.
e. The evaluation
shall be used to establish an appropriate discharge plan.
3. A registered nurse or social worker shall
develop or supervise the development of a discharge plan if the discharge
planning evaluation indicates the need for a discharge plan.
a. The hospital shall arrange for
implementation of the discharge plan.
b. The hospital shall transfer or refer
inpatients and outpatients to appropriate facilities, agencies, or outpatient
services, as needed, for follow-up care.
c. Designated hospital personnel shall
complete the "Continuity of Care" form approved by the Department for each
patient who is discharged to another health care facility licensed under the
provisions of R.I. Gen. Laws Chapter 23-17 (e.g., nursing facility). The
Continuity of Care form and instructions for its use should be downloaded from
the Department's website:
http://health.ri.gov
4. The hospital shall reassess its discharge
planning process on an on-going basis. The reassessment shall include a review
of discharge plans, as well as a review of patients who were discharged without
plans, to ensure that the process is responsive to discharge needs.
D. Discharge Planning: Substance
Use Disorder, Opioid Use Disorder, and Chronic Addiction
1. Evaluation
a. The hospital must administer a
standardized evaluation to all patients with an indication of substance use
disorder, opioid use disorder, or chronic addiction. If the patient declines
evaluation this must be documented in the medical record. If the patient is
determined after an evaluation to have a substance use disorder or opioid use
disorder then appropriate medical services will be offered to the patient.
Services offered to the patient shall include, but are not limited, to
clinically appropriate inpatient and outpatient services.
b. Hospitals shall have a written policy for
evaluation available upon request, inspection, or related to investigation of
complaint.
2. Laboratory
Screening
For every patient presenting to the hospital with an opioid
overdose, the hospital must order a laboratory screening to determine what
substance(s) caused the overdose. If the patient refuses the laboratory
screening, the hospital is still in compliance as long as the test was ordered.
If the patient declines screening this must be documented in the medical
record.
3. Education
a. The hospital must educate all patients who
are prescribed opioids on the risks and benefits of prescribed opioids as well
as safe storage and disposal in accordance with the section titled "Patient
Education/Consent" in Rules and Regulations for Pain Management, Opioid Use and
the Registration of Distributors of Controlled Substances in Rhode
Island.
b. When patients present
with indications of illicit drug use (including but not limited to the use of
illegal substances or the use of diverted prescription drugs), the hospital
must educate such patients on illicit drug use, including evidence-based harm
reduction strategies such as proper syringe disposal and how to obtain
non-prescription syringes.
c. If
the Department issues a health advisory (either statewide or for the particular
geographic area in which the hospital is contained) regarding an increase in
overdoses or overdose deaths, the hospital is required to educate illicit drug
use and diverted overdose patients with evidence-based harm reduction
strategies.
4. Naloxone
a. The hospital must have a written policy
that outlines when a prescriber should dispense or prescribe naloxone to
patients. This policy must include a list of conditions that would prompt the
dispensing or prescribing of naloxone. A sample list of conditions is found in
the Department's guidance document "Levels of Care for Emergency Departments
and Hospitals for Treating Overdose and Opioid Use Disorder."
b. For patients meeting the conditions set
out in the hospital's policy, a prescriber must dispense or prescribe
naloxone.
c. For those patients who
are dispensed or prescribed naloxone, education regarding how to administer
naloxone shall be provided to patients prior to discharge.
d. Hospitals shall have a written policy for
naloxone available upon request, inspection or related to investigation of
complaint.
5. Peer
Recovery
a. The hospital shall offer all
patients the opportunity to speak with a peer recovery support specialist, if
those patients:
(1) are diagnosed with
substance use disorder or opioid use disorder using then evaluation protocol
required by §4.6.1(D)(1) of this Part, or
(2) are treated for an opioid
overdose.
b. To fulfill
the above requirement, at a minimum the hospital must inform the patient that
the hospital will contact a peer recovery support specialist on the patient's
behalf.
c. Hospitals shall have a
written policy for peer recovery available upon request, inspection or related
to investigation of complaint.
6. Treatment Services
a. The hospital shall provide information to
patients about appropriate inpatient and outpatient services, including but not
limited to medication assisted treatment and biopsychosocial treatment, if
those patients:
(1) are diagnosed with
substance use disorder or opioid use disorder using then evaluation protocol
required by §4.6.1(D)(1) of this Part, or
(2) are treated for an opioid
overdose.
b. Hospitals
must make a good faith effort to assist the patient in obtaining an appointment
with a qualified licensed professional. To fulfill the above requirement, at a
minimum the hospital must present a list of names, addresses, and phone numbers
of appropriate inpatient and outpatient services. This list shall include
information about medication-assisted treatment. If the patient declines to
receive information or assistance about treatment services this must be
documented in the medical record.
c. Hospitals shall have a written policy for
treatment services available upon request, inspection or related to
investigation of complaint.
7. Notification of Emergency Contact
a. Prior to discharge and with patient
consent, the hospital will attempt to notify the patient's emergency contacts
and peer recovery support specialist (if any of these individuals have been
identified) pursuant to R.I. Gen. Laws §
23-17.26-3(iii).
If the patient declines notification of an emergency contact or recovery coach,
the treating provider will document this refusal in the medical
record.
b. Hospitals shall have a
written policy for notification of emergency contact available upon request,
inspection, or related to investigation of complaint.
8. Right to Refuse Treatment
Pursuant to R.I. Gen. Laws §
23-17-19.1(4),
a patient has the right to refuse any screening, treatment, or service
described in §§4.6.1(D)(1) through (7) of this Part.
9. Overdose Reporting
Hospitals shall comply with the reporting requirements
found in Rules and Regulations Pertaining to Opioid Overdose Prevention and
Reporting (Part 20-20-5 of this Title).
E. Financial Interest Disclosure
1. Any health care facility licensed pursuant
to R.I. Gen. Laws Chapter 23-17, which refers clients to another such licensed
health care facility or to a residential care/assisted living facility licensed
pursuant to R.I. Gen. Laws Chapter 23-17.4, or to a certified adult day care
program in which the referring entity has a financial interest shall, at the
time a referral is made, disclose in writing the following information to the
client:
a. that the referring entity has a
financial interest in the facility or provider to which the referral is being
made;
b. that the client has the
option of seeking care from a different facility or provider which is also
licensed and/or certified by the state to provide similar services to the
client.
2. The referring
entity shall also offer the client a written list prepared by the Department of
Health of all such alternative licensed and/or certified facilities or
providers. Said written list may be obtained by contacting:
Rhode Island Department of Health, Center for Health
Facility Regulations
3 Capitol Hill, Room 306
Providence, RI 02908
401.222.2566
3. Non-compliance with
§§4.6.1(E)(1) through (2) of this Part shall constitute grounds to
revoke, suspend or otherwise discipline the licensee or to deny an application
for licensure by the Director, or may result in imposition of an administrative
penalty in accordance with R.I. Gen. Laws §23-17.10.
4.6.2
Patient Care
Management
A. A mechanism shall be
established for the periodic review and revision of patient care policies and
procedures.
B. There shall be
evidence that medical, nursing and other services are provided under an
integrated written plan of care for each patient. Written care plans shall
identify problems, goals, and interventions. Goals shall be
measurable.
C. All orders for
medications or treatments must be in writing. An order is considered to be in
writing if: it is written and signed by a lawfully authorized person; or it is
dictated to and transcribed by a registered nurse or other appropriately
licensed person onto the order form. Additionally, the registered nurse or
other appropriately licensed person must: date the order and identify the
telephone or verbal order by the name and title of the authorized individual
who gave the order; and sign the order entry with his/her own name and title.
All verbal or telephone orders must be appropriately signed by a practitioner
involved in the care of the patient no later than the end of the next calendar
day.
1. Hospitals may implement a standing
orders program authorizing licensed nurses and other licensed health care
professionals acting within their scopes of practice to administer influenza
and/or pneumococcal vaccines without a physician signature in accordance with
an institution-approved or physician-approved protocol. The standing orders
shall be in accordance with "Immunization of Health-Care Personnel:
Recommendations of the Advisory Committee on Immunization Practices (ACIP),"
incorporated above at §
4.2(A)(19)
of this Part.
D. There
shall be a written policy for appropriate minimum, specific testing for all
surgical inpatients and for all patients who are undergoing specific procedures
requiring anesthesia in the inpatient and outpatient settings.
E. The hospital shall assure that drugs and
biologicals are only administered by appropriately licensed professionals,
including but not limited to, physicians, nurses, or physician assistants.
Medication administration technicians shall not administer drugs or biologicals
under any circumstances.
F. The
hospital shall provide care and services to all patients in accordance with the
prevailing community standard of care.
G. Medical Restraints:
In acute medical and pre/post-surgical care, a patient
shall be free from physical and chemical restraint that is not medically
necessary. A restraint shall only be used if needed to improve the patient's
well-being and only if less restrictive interventions have been determined to
be ineffective to protect the patient or others from harm.
H. Behavioral Restraints:
A patient shall be free from seclusion or restraint imposed
as a means of coercion, discipline, convenience or retaliation by staff.
Seclusion or restraint employed for behavior management shall only be used in
emergency situations if needed to ensure the patient's or other's physical
safety and less restrictive interventions have been determined to be
ineffective.
1. Restraints/seclusion
use shall be prescribed in writing and signed by a physician or other licensed
practitioner acting within his/her scope of practice and permitted by the
hospital to order restraints/seclusion. The type and duration of
restraints/seclusion shall be specified. Standing or "on an as needed basis"
(i.e., PRN) orders shall not be permitted.
2. Restraints/seclusion, if used, shall be
addressed in the written treatment plan for the patient.
3. Restraints/seclusion use shall be based on
an assessment of the patient, implemented in the least restrictive manner
possible, implemented in accordance with safe and appropriate restraining
techniques, and discontinued at the earliest possible time.
4. The condition of a restrained/secluded
patient shall be continually assessed, monitored, and reevaluated.
I. Pain Assessment
All health care providers licensed by this state to provide
health care services and all health care facilities licensed under R.I. Gen.
Laws Chapter 23-17, shall assess patient pain in accordance with the
requirements of the "Rules and Regulations Related to Pain Assessment"
promulgated by the Department.
4.6.3
Provision of Interpreter
Services
A. Every hospital shall, as a
condition of initial or continued licensure, provide a qualified interpreter,
if an appropriate bilingual clinician is not available to translate, in
connection with all services provided to every non-English speaker who is a
patient or seeks appropriate care and treatment and is not accompanied or
represented by an appropriate qualified interpreter or a qualified sign
language interpreter who has attained at least sixteen (16) years of
age.
B. No later than 1 July 2002,
each hospital shall develop, establish and maintain a formal plan for the
provision of language interpretation with respect to the provision of hospital
services in all licensed settings.
1. Each
hospital shall establish criteria for the qualification of interpreters. In
addition to fluency in a language other than English, interpreters shall have
demonstrated competency in the following topics, at a minimum:
a. the appropriate role of a medical
interpreter;
b. the confidentiality
of health care information;
c. the
ethical issues involved in serving as a medical interpreter;
d. common medical terminology; and
e. relevant hospital policies and
procedures.
2. Each
hospital shall review the qualifications of and designate individuals as
interpreters in specific languages. Such reviews and designations shall be
documented.
3. Each hospital shall
establish criteria for the qualification of bilingual clinicians. In addition
to being bilingual, clinicians shall have knowledge of the following topics:
a. the appropriate role of a medical
interpreter;
b. the ethical issues
involved in serving as a medical interpreter;
c. common medical terminology; and
d. relevant hospital policies and
procedures.
4. Each
hospital, for the purposes of providing interpretive services, shall review the
qualifications of and designate clinicians as bilingual in specific languages.
Such reviews and designations shall be documented.
5. Each hospital may also contract with
appropriate off-site interpreter service providers for the provision of
qualified interpreter services provided that hospital has received the prior
written approval of such arrangements from the state agency.
C. Each hospital shall post a
multi-lingual notice in conspicuous places setting forth the requirements of
§4.6.3(A) of this Part in English, include the internationally-recognized
symbol for sign language (including a relay number for access by hearing/speech
impaired (TTY)) and include, at minimum, three (3) most common foreign
languages used by the hospital as determined by the hospital.
4.6.4
Central Service
Functions
A. Hospitals with central
service functions shall operate, under the supervision of a qualified person, a
central service for the processing, sterilization, storing and dispensing of
clean and sterile supplies and equipment.
B. Adequate facilities shall be provided for
the cleaning, preparation, sterilization, aeration, storage and dispensing of
supplies and equipment for patient care.
C. Areas for the processing of clean and
dirty supplies and equipment shall be separated by physical barriers.
D. Written procedures shall be established
for all central service functions including:
1. procedures for all sterilization and for
monitoring the effectiveness thereof;
2. appropriate disposal of wastes and
contaminated supplies; and
3.
compliance with the provisions of Comprehensive Accreditation Manual for
Hospitals, incorporated above at §
4.2(A)(23)
of this Part.
E. Such
procedures shall be subject to the approval of a multidisciplinary hospital
group.
F. Reports of
bacteriological tests and dated recordings of thermometer charts and inspection
records shall be maintained in accordance with written procedures.
G. Central service procedures shall apply
wherever sterilization is performed.
4.6.5
Dietary Service
A. Each facility shall maintain a dietary
service directed by a full-time person qualified by training and experience in
organization and administration of food service.
B. Each hospital shall have at least one
Registered Dietitian, licensed by the state, to direct nutritional aspects of
patient care and to advise on food preparation and service.
C. Adequate space, equipment and supplies
shall be provided for the efficient, safe and sanitary receiving, storage,
refrigeration, preparation and service of food and other related aspects of the
food service operation.
1. Any construction,
addition, alterations affecting food service operations shall be in conformity
with the requirements of R.I. Gen. Laws §
23-1-31.
D. Each hospital food service operation shall
comply with the applicable standards of the Rhode Island Food Code (Part
50-10-1 of this Title).
E. Foods
shall be prepared by methods that conserve nutritive value, flavor and
appearance.
F. Foods served shall
be palatable, attractive and at proper temperature.
G. Written policies and procedures shall be
established for dietary services, pertaining to but not limited to the
following:
1. responsibilities and functions
of personnel;
2. standards for
nutritional care in accordance with Recommended Dietary Allowances,
incorporated above at §
4.2(A)(12)
of this Part;
3. identifying
patients at nutritional risk;
4.
precise delivery of patient's dietary order;
5. alterations or modifications to diet
orders or schedules;
6. food
purchasing, storage, preparation and service;
7. safety and sanitation relative to
personnel and equipment;
8.
ancillary dietary services, including food storage and preparation in satellite
kitchens, and vending operations;
9. ice making in accordance with Good
Manufacturing Practices for Food (Part 50-10-4 of this Title); and
10. standards for enteral nutritional
care.
H. Any hospital
engaged in processing, handling, or both, of frozen foods shall be subject to
standards of Good Manufacturing Practices for Food (Part 50-10-4 of this
Title).
I. There shall be a diet
manual maintained by the dietary service which shall be reviewed, revised as
necessary and approved by a multidisciplinary group at least every five (5)
years and more often as necessary. Diets served to patients shall comply with
the principles set forth in the diet manual.
J. All patient diets shall be ordered in
writing by the physician.
K.
Assessments, observations and information pertinent to dietetic treatment shall
be recorded in the patient's medical record by the dietitian.
L. A hospital contracting for food service
shall require, as part of the contract, that the contractor comply with the
provisions of these regulations.
4.6.6
Disaster && Mass Casualty
Program
A. Each hospital shall develop
and maintain a written disaster plan which shall include provisions for
complete evacuation of the facility and for the timely care of casualties
arising from both external and internal disasters based on the guidelines of
Comprehensive Accreditation Manual for Hospitals, incorporated above at §
4.2(A)(23)
of this Part.
B. The plan shall
also include provisions for:
1. disaster-site
triage and distribution of patients to ensure the most efficient use of
available facilities and services;
2. a mechanism for physician identification
as well as route access and entrance to the hospital; and
3. back-up or contingency plans to address
internal systems, electronic disasters, including a backup system for an
electronic medical record file system, and/or equipment failures.
C. The plan(s) shall be developed
and coordinated with the appropriate state and local agencies and
representatives concerned with emergency, safety, rescue and disaster
preparedness.
D. The disaster plan
shall be rehearsed at least twice a year preferably as part of a coordinated
drill in which other community emergency services agencies participate with
hospital, medical, administrative, nursing and other personnel.
E. Written reports and evaluation of all
drills shall be maintained.
F. A
copy of the plan(s) and any revision thereto shall be submitted to the
licensing agency.
4.6.7
Emergency Service
A. Each
hospital shall have a well-defined plan for emergency services based on
community need and on the capability of the hospital and its specialized
supportive services.
1. The hospital plan for
emergency services shall be developed in cooperation with representatives of
community emergency medical service agencies or groups (e.g., emergency medical
service councils).
2. Hospitals
without an emergency department or service shall have written policies and
procedures governing the handling of emergencies.
3. Pursuant to R.I. Gen. Laws §
23-17-26,
every hospital with an emergency medical care unit shall provide to every
person prompt lifesaving medical treatment in an emergency:
a. without discrimination based on economic
status or source of payment; and
b.
without delaying treatment for the purpose of prior discussion of source of
payment;
c. unless such delays can
be imposed without material risk to the health of the person.
B. Each hospital
emergency department or service shall be organized to provide twenty-four (24)
hour services with adequate professional and ancillary staff coverage to ensure
that all persons are treated within a reasonable length of time, commensurate
with the priority for treatment.
C.
Every emergency department or service shall have a person qualified by training
and experience in the department twenty-four (24) hours a day who shall
determine the nature, level and urgency of care required of all persons seeking
treatment and to categorize them accordingly, assuring that serious cases are
accorded priority treatment. If such person is a non-physician, he or she shall
serve under the supervision of the physician-in-charge and in accordance with
policies and procedures acceptable to the medical staff and hospital
administration.
D. Every hospital
emergency department or service shall have a qualified member of the medical
staff assigned as physician-in-charge or made responsible for the emergency
medical services, to ensure that emergency patient care services meet the
standards of these regulations and for the coordination of physician coverage
according to a plan established by the medical staff and approved by the
governing authority.
E. At least
one (1) physician on duty in the emergency department of a general hospital
shall be certified by the American Board of Emergency Medicine or the American
Board of Osteopathic Emergency Medicine or shall be eligible to sit for
examination of one of the aforementioned boards; or shall be Board certified or
eligible in Family Practice, Internal Medicine or General Surgery with at least
one (1) year of practice in emergency medicine; or those physicians who have
practiced in an emergency department setting for at least seven thousand
(7,000) hours in sixty (60) months with two thousand (2,000) of said practice
hours having been completed in the last twenty-four (24) months.
1. At least one physician on duty or
immediately available "on call" in the emergency department of a psychiatric
hospital shall be certified by the American Board of Psychiatry and Neurology
or shall be eligible to sit for the examination of the aforementioned
board.
F. Additional
staff in the emergency department or service of a general hospital shall meet
the following qualifications:
1. a physician
who is Board certified or eligible in Family Practice, Internal Medicine,
General Surgery or Pediatrics;
2. a
physician with more than two (2) years of practice following full licensure;
or
3. in those hospitals having
approved residency training programs, by residents with more than two (2) years
of training in the specialties of internal medicine, surgery, pediatrics,
and/or emergency medicine, when such emergency department training is part of
their formal residency training program.
G. In addition, hospitals shall have
available on call twenty-four (24) hours a day, physicians in specialties
appropriate to the scope of services provided by the hospital.
H. A current roster of physicians, medical
specialists or consultants on emergency call, including alternates, shall be
kept posted at all times in the emergency department or service.
I. The staffing pattern of nursing and allied
health personnel shall be consonant with the scope and complexity of the
emergency services provided. No less than one registered nurse who has training
and experience in emergency care shall be assigned to the emergency services at
all times.
J. A continuing
inservice education training program in emergency medical care, including
prehospital care protocols and standing orders in accordance with the
provisions of the Department's "Rules and Regulations Relating to Emergency
Medical Services", shall be conducted for all categories of health personnel in
the emergency department or service in accordance with §4.5.7 of this
Part.
K. There shall be written
policies governing emergency patient care services, supported by appropriate
procedure manuals and reference materials. The policies and procedures shall
pertain to at least the following:
1. medical
staff and obligation for emergency patient care in accordance with
§4.6.7(A)(3) of this Part;
2.
circumstances under which definitive care shall not be provided and procedures
to be followed in referrals;
3.
assignment of clinical privileges according to levels of professional
competence;
4. procedures that may
or may not be performed in the emergency department or service area;
5. handling of persons who are emotionally
ill, under the influence of drugs or alcohol, dead on arrival, or other
categories of special cases as determined necessary;
6. procedures for early transfer of severely
ill or injured to special in-house treatment areas or to other
facilities;
7. written instructions
to be given for follow-up care and disposition of all cases;
8. notification of patient's personal
physician and transmission of relevant reports;
9. disclosure of patient information in
accordance with federal and state law;
10. communication with police, health
authorities and emergency vehicle operators;
11. appropriate utilization of observation
beds;
12. procurement of equipment
and drugs; and
13. operation of the
emergency department or service in times of disaster.
L. A list of poison antidotes and the
telephone number of the Rhode Island Poison Control Center shall be available
in the emergency department or service area.
M. The emergency service shall have necessary
supportive services available on a twenty-four (24) hour basis. These services
shall include, in accordance with these regulations, anesthesia service
(§4.6.20 of this Part); clinical laboratory service with arterial blood
gas analysis capability (§4.6.9(E)(1) of this Part); blood transfusion
services (§4.6.9(H) of this Part); pharmaceutical service (§4.6.14 of
this Part); radiology service including protocol to govern the interpretation
by a radiologist, of diagnostic images produced by x-ray or other modalities,
including a procedure for the prompt communication of the radiologist's
interpretation (§4.6.15(A) of this Part); and surgical service
(§4.6.19 of this Part).
N.
Facilities, equipment, supplies and drugs for the reception, appraisal,
examination, treatment and observation of emergency room patients shall be
determined by the amount, type and extensiveness of services
provided.
O. No less than the
following special supplies and equipment shall be available and located within
the general hospital emergency department or service:
1. oxygen;
2. electrocardiograph;
3. cardiac monitor and defibrillator with
battery pack;
4.
pacemaker;
5. central venous
catheter set-up;
6. gastric lavage
equipment;
7. suction
device;
8. intravenous fluids and
administration devices;
9.
endotracheal intubation, pericardiocentesis, thoracostomy, and cricothyrotomy
trays;
10. mechanical ventilator
(readily available);
11. emergency
obstetrical pack; and
12. pulse
oximeter for measuring carboxyhemoglobin levels.
P. The emergency drug cart(s) and adjunctive
emergency equipment shall be checked by an appropriate, designated individual
at least once per shift to assure that all items required for immediate
availability are actually contained in the cart and are in usable condition.
1. A signed record of such periodic
inspections shall be maintained by the appropriate emergency department
staff.
Q. A medical
record shall be maintained on every patient seeking emergency care. For each
visit to the emergency service, the medical record shall contain documentation
relating to the following:
1. patient
identification (name, address, age and sex);
2. time and means of arrival;
3. pertinent medical history of the illness
or injury and physical findings;
4.
emergency care given before arrival;
5. diagnostic and therapeutic
orders;
6. reports of procedures,
tests, treatments and findings;
7.
diagnostic impression;
8.
conclusion at termination of evaluation/treatment, including final disposition
of patient, condition on discharge or transfer, and any instructions given for
follow-up care;
9. a patient's
leaving against medical advice; and
10. origin of incoming patient and
destination of patient at discharge.
11. the standardized Rhode Island EMS
Ambulance Run Report ("run report") provided, prepared and signed by the
licensed emergency medical technician who completed the form.
R. A mechanism shall be developed
to include the emergency department record into the patient's medical record in
accordance with §4.6.10(C) of this Part.
S. Those hospitals which have provisions for
Mobile Intensive Care Communications manned by technical personnel shall comply
with the requirements of R.I. Gen. Laws Chapter 23-17.6.
T. The standards of §4.5.9 of this Part
pertaining to "Rights of Patients" shall be observed for all patients treated
in the emergency department or service. In addition, hospitals shall:
1. provide access to a physically separate
room, office or chapel, wherein privacy can be guaranteed, for families when
circumstances shall warrant (such room may have alternative uses);
and
2. inform emergency service
patients, by posting in an easily visible location, that the routine cost for
use of the emergency service does not include additional professional service
charges except in the case where residents who perform the service are employed
by the hospital.
U.
Restocking of Municipal Ambulance Supplies
1.
Pursuant to R.I. Gen. Laws §
23-4.1-7.1,
every hospital licensed in accordance with R.I. Gen. Laws Chapter 23-17, is
required to restock supplies listed by the Director of Health that are used by
a licensed emergency medical services provider in transporting emergency
patients to such hospital.
a. Restocking will
not be required:
(1) in the absence of
documentation of supply usage on the emergency patient's R.I. EMS ambulance run
report, or
(2) if the licensed
emergency medical services provider bills any third party payer for the
supplies which were used.
b. The listing of supplies that are subject
to mandatory restocking in accordance with §4.6.7(U)(1) of this Part is
available by contacting:
Rhode Island Department of Health, Office of Emergency
Medical Services
3 Capitol Hill, Room 105
Providence, RI 02908
401-222-2401
V. Diversion Plan - Disaster Planning and
Response
Hospitals with an emergency department or service shall
maintain participation in and compliance with the Rhode Island Diversion Plan.
Such compliance shall include retaining all required communication devices
(e.g., Nextel system) in good operating condition and training of an adequate
number of staff in the use of communication equipment as it relates to disaster
planning/response and the proper execution of the Diversion Plan.
4.6.8
Home Care
Services
A. Hospitals with home care
services as defined in §
4.3 of this Part, shall have
an organizational structure designed in accordance with the provisions of
§4.5.6 of this Part.
B. A
qualified person shall be responsible for the administrative and coordinating
functions of the home care program. Such a person may be the physician
responsible for the general direction of the medical services of the
program.
C. A multidisciplinary
group with representatives of the services provided shall be established to
serve in an advisory capacity. The group shall meet as frequently as necessary,
maintain written documented reports of its proceedings, and shall be
responsible for no less than the following:
1.
develop and recommend policies as required under §§4.6.1 through
4.6.2 of this Part, and such other policies as may be required pertaining to
professional and ancillary services provided by and through the
program;
2. assist in maintaining
liaison with other health care providers;
3. assist in quality improvement
program;
4. review annually all
program policies and make recommendations; and
5. such other related functions as may be
deemed advisable within the scope of responsibility of said group.
D. The general responsibility for
the medical services provided in connection with the home care program shall be
vested in an appropriately designated member of the medical staff in accordance
with hospital policy.
1. Regularly scheduled
meetings of personnel responsible for the provision of services (such as
program staff, hospital personnel and representatives of participating
community agencies) shall be held to affect coordination of patient care
services.
E. Home health
care program personnel shall be qualified to perform their respective duties in
accordance with state licensure and acceptable professional qualification
standards.
F. A policy and
procedure manual shall be established which shall contain guidelines
specifically related to the program such as:
1. definition of the scope of services
offered;
2. admission and discharge
policies;
3. procedures to be
performed in the home;
4.
circumstances that may require the patient to return to the hospital for
treatment;
5. care of patients in
an emergency; and
6. other such
related policies and procedures.
G. A medical record shall be maintained for
every patient receiving services in accordance with the provisions of
§4.6.10 of this Part.
H.
Arrangements for the provision of services by a participating community agency
or individual provider shall be documented by means of a written signed
agreement or contract which shall include specific terms governing the mutual
responsibilities for the nature, scope and cost of service to be
provided.
4.6.9
Laboratory Service
A. The
director of laboratory service shall be a member of the medical staff,
preferably a pathologist certified by the American Board of
Pathology.
B. Staff personnel shall
be sufficient in number and adequately qualified and licensed, as applicable,
pursuant to R.I. Gen. Laws Chapter 23-16.3.
C. Laboratories shall have adequate space,
equipment and supplies to perform the required volume of work with accuracy,
efficiency and shall conform with the fire safety requirements found in section
15.4 of NFPA 99: Health Care
Facilities Code, incorporated above at §
4.2(A)(15)
of this Part.
D. Provisions shall
be made to assure continuous availability of emergency laboratory services,
including blood transfusion services.
E. Clinical Laboratory Services
1. Examination in the fields of hematology,
chemistry, microbiology, immunology, urinalysis, immunohematology and other
services necessary to meet patient care needs shall be provided within the
institution in accordance with standard medical practice and these
regulations.
2. Hospital clinical
laboratory services shall be provided in accordance with Section 10.0 "Records
and Reports," Section 12.0 "Procedural Manual," Sections
13.1 and
13.2 of "Collection,
Identification and Examination of Specimens," Section 14.0 "Radiobioassay,
Pathological, and Cytological Examinations," and Sections
15.1,
15.2, and 15.2.1 of
"Methodologies for Quality Control" of "Rules and Regulations for Licensing
Clinical Laboratories and Stations."
F. Other Services
1. Other services not specifically required
by these regulations to be provided on-site may be provided either by the
hospital directly or by contractual arrangement with a Rhode Island licensed
laboratory. Such services may include tissue pathology, cytotechnology,
cytogenetics, etc.
2. In the latter
instance, written policies and procedures shall be established governing prompt
transportation of specimens and submission of reports; and all surgically
removed tissues shall be examined by a pathologist and signed reports shall be
included in the patient's medical record.
3. There shall be a written mechanism for
internal and/or external professional review of tissue pathology services as
needed.
G. Autopsy
Service
1. An autopsy service shall be
provided either directly by the hospital or by contractual arrangement with
another licensed institution.
2. In
either case, the facility shall have adequate space, equipment and personnel
for the expected workload; autopsies on reportable death cases shall be subject
to the requirements of rules and regulations pertaining to Medical Examiner
System (Part 60-10-1 of this Title).
H. Blood Banks && Transfusion
Services:
1. Each hospital shall provide
appropriate facilities and equipment for the procurement, storage and
administration of whole blood and blood products either directly or through
participation in a multi-facility community blood collection, testing, storage
and processing system. Psychiatric hospitals not providing this service shall
be exempt from this requirement.
2.
Written policies and procedures for all phases of operation of blood banks and
transfusion services shall be established and periodically revised to comply
with standards of Standards for Blood Banks and Transfusion Services,
incorporated above at §
4.2(A)(21)
of this Part.
I. Reports
Authenticated and dated reports of all pathological and
clinical laboratory examinations including autopsies shall be made part of the
patient's medical record in a timely manner as determined by hospital
policy.
4.6.10
Medical Records
A. The medical
record service shall be under the full-time direction of a registered medical
record administrator or a registered health information administrator (RHIA)
who is certified by the American Health Information Management Association or
who possesses equivalent training and experience.
B. The medical record department shall be
adequately staffed and equipped to facilitate the accurate processing,
checking, indexing, filing and retrieval of all medical records.
C. A medical record shall be established and
maintained for every person treated on an inpatient, outpatient (ambulatory) or
emergency basis, in any unit of the hospital. The record shall be available to
all other units.
D. Written
policies and procedures shall be established regarding content and completion
of medical records by an appropriate multidisciplinary group. Also, this group
shall be responsible for ongoing review.
E. Entries in the medical record shall be
made by the responsible person in accordance with hospital policies and
procedures.
F. The medical record
shall contain sufficient information to identify the patient and the problem,
to describe the treatment and document the results.
G. The content of all medical records
(inpatient, outpatient, ambulatory and emergency) shall conform with applicable
standards of Comprehensive Accreditation Manual for Hospitals, incorporated
above at §
4.2(A)(23)
of this Part. Further, medical records shall document the primary language of
the patient; shall document any hospital provision of interpretive services by
bilingual clinicians, qualified interpreters, or qualified sign language
interpreters; and shall document the inability to provide interpretive services
by bilingual clinicians, qualified interpreters, or qualified sign language
interpreters as required by the patient.
H. The medical record, including the
discharge summary, shall be completed within thirty (30) days of the patient's
discharge.
I. Provisions shall be
made for the safe storage of medical records in accordance with NFPA 99:
Standard for the Protection of Records, incorporated above at §
4.2(A)(16)
of this Part.
J. All medical
records either original or accurate reproductions shall be preserved for a
minimum of five (5) years following discharge of the patient in accordance with
R.I. Gen. Laws §
23-3-26.
1. Records of minors shall be kept for at
least five (5) years after such minor shall have reached the age of 18
years.
K. A mechanism
shall be established to ensure confidentiality of all medical records,
including computerized or electronic records.
L. Patient Access to Medical Records
1. Medical records, even though the property
of the facility, may be requested by the patient or an authorized
representative. All medical record requests shall be made in writing.
2. Charges shall not be made if the record is
requested for continuity of care purposes or for immunization records required
for school admission or by the applicant or beneficiary or individual
representing an applicant or beneficiary for the purposes of supporting a claim
or appeal under the provision of the Social Security Act or any federal or
state needs-based benefit program such as Medical Assistance, RIte Care,
Temporary Disability Insurance and Unemployment Compensation.
3. No fees shall be charged to applicants for
benefits in connection with a Civil Court Certification Proceeding or a claim
under the Worker's Compensation Act R.I. Gen. Laws Chapter 28-29 as reflected
in R.I. Gen. Laws §
23-17-19.1(16).
4. Records must be provided within thirty
(30) days of the request or within thirty (30) days of completion of the
medical record (whichever is later).
M. Hospital Closure/Change in Ownership and
Medical Records
1. A hospital that
voluntarily closes or changes ownership shall initiate a multimedia press
release, within thirty (30) days, notifying the public of the facility closure.
Such notice shall include the procedure by which individuals may obtain their
medical records. In addition, written notification of facility closure and a
plan for disposition of medical records shall be provided to the Department at
least thirty (30) days prior to the closure/change of ownership of the
hospital.
2. If a hospital changes
ownership, all medical records in original, electronic, or microfilm form shall
remain in the hospital or related institution, become part of the ownership
agreement, and it shall be the responsibility of the new owner to protect and
maintain these records.
3. If any
hospital shall be finally closed, its medical records may be delivered to any
other hospital(s) in the vicinity willing to accept and retain same, or may be
delivered to any other lawfully permitted agency.
4. Medical records not claimed that are
beyond five (5) years of the last date of discharge may be destroyed, provided
that the requirements of §4.6.10(J)(1) of this Part are met. Patients or
their representatives shall be provided with an opportunity to claim their
records prior to destruction of the records in the event of closure or change
in ownership of the hospital.
4.6.11
Nursing Service
A. Each hospital shall have an organized
nursing department. A registered nurse qualified on the basis of education,
experience and clinical ability shall be responsible for the nursing
service.
B. There shall be a
sufficient number of registered nurses on duty at all times to plan, assign,
supervise and evaluate nursing care as well as to provide direct patient care
as required.
1. There shall be a registered
nurse on each inpatient unit at all times.
C. The number and type of registered nurses
and ancillary nursing personnel shall be based on evaluation of patient care
needs and staff capabilities for each patient care unit.
1. The hospital shall designate a registered
nurse responsible for development of a written nursing staffing plan. This plan
shall be:
a. specific by nursing
unit;
b. developed in collaboration
with nursing representation from each unit; and
c. flexible to respond to changes in patient
acuity and/or census.
D. Nursing personnel shall be assigned to
patient care units in a manner that minimizes the risk of cross-infection and
accidental contamination.
E. There
shall be written evidence that the nursing service provides safe and effective
nursing care, through the comprehensive assessment and planning of each
patient's care based upon such assessment and the implementation of the
plan.
4.6.12
Nuclear Medicine
A. Hospitals
with nuclear medicine service may provide such services either directly or per
contractual arrangement with another facility having a licensed program in
accordance with "Rules and Regulations for the Control of Radiation."
B. The direction of the nuclear service shall
be provided by a member of the medical staff who through education and
experience is qualified in nuclear medicine.
C. Policies and procedures shall be adopted
for the receiving, handling, use, storage and disposition of radioactive
isotopes based on the guidelines of Brodsky, Allen, Principles and Practices
for Keeping Occupational Radiation Exposures at Medical Institutions as Low as
Reasonably Achievable, incorporated above at §
4.2(A)(8) of
this Part.
D. The type, quantity
and quality of equipment for the nuclear medicine service shall be adequate to
conduct reliable diagnostic studies and treatment.
E. There shall be quality control procedures
and a quality management program as required under Part C of the "Rules and
Regulations for the Control of Radiation."
F. Records of services rendered shall be
maintained and incorporated in the patient's medical record. Other records as
required by law shall be maintained.
G. Radiobioassay Examinations
A nuclear medicine department performing radiobioassay
examinations shall comply with the "Rules and Regulations for the Control of
Radiation." Furthermore, the nuclear medicine department shall be registered
with the Office of Occupational and Radiological Health and conform to such
directives as may be promulgated by the Department of Health for possession and
use of radioactive materials.
4.6.13
Outpatient (Ambulatory Care)
Services
All hospital outpatient (ambulatory care) services shall
conform to all applicable regulations, since such services are an integral part
of the hospital and covered under its license.
4.6.14
Pharmaceutical
Service
Each hospital shall provide pharmaceutical services either
directly within the institution or by contractual arrangement. In either
instance, there shall be evidence of a current pharmacy license in compliance
with R.I. Gen. Laws §
5-19.1-8.
Pharmaceutical services shall be provided in accordance with "Rules and
Regulations Pertaining to Pharmacists, Pharmacies && Manufacturers,
Wholesalers && Distributors."
4.6.15
Medical Imaging Services
A. Each hospital, except those psychiatric
hospitals who elect not to provide medical imaging services, shall maintain
such services including provisions for emergency coverage, directed by a
qualified radiologist, preferably one certified by the American Board of
Radiology or having the equivalent in training and experience.
B. Hospitals maintaining radiotherapy
services shall provide for their safe and effective operation under a director
qualified by training and experience in therapeutic radiology.
C. X-ray equipment facilities and services
shall be registered with the Office of Occupational and Radiological Health in
accordance with Part B of "Rules and Regulations for the Control of
Radiation."
D. Sufficient technical
personnel shall be available, consistent with the scope of services
provided.
E. Adequate space and
equipment shall be provided for medical imaging services including facilities
for processing and storage of films and records.
F. Authenticated reports of the radiologist's
interpretation, consultation and therapy shall be part of the patient's medical
record.
G. Reports and films shall
be preserved in accordance with §4.6.10(I) of this Part.
H. All aspects of mammography services shall
be managed in accordance with the provisions of the Rules &&
Regulations Related to Quality Assurance Standards for Mammography of the Rhode
Island Department of Health and the applicable U.S. Food and Drug
Administration (USFDA) regulations in 21 C.F.R. Part
900
(2017).
4.6.16
Radiation Safety
A. The
requirements of Parts A and F of "Rules and Regulations for the Control of
Radiation" pertaining to x-ray equipment, safety precautions, monitoring of
personnel and areas, administrative procedures, maintenance of records and
other requirements shall apply to medical imaging services.
B. The requirements of Part H of "Rules and
Regulations for the Control of Radiation" pertaining to particle accelerators
shall apply to radiotherapy services utilizing particle accelerators.
4.6.17
Reporting of Hospital
Events && Incidents
A.
Reportable Deaths:
1. All patient deaths
occurring within the hospital, which are reportable in accordance with Rules
and Regulations Pertaining to Medical Examiner System (Part 60-10-1 of this
Title), shall be reported to the Office of State Medical Examiners.
2. In addition to the above, hospitals shall
be subject to the appropriate requirements of Rules and Regulations Pertaining
to Medical Examiner System (Part 60-10-1 of this Title).
B. Reportable Events
1. The hospital shall, within twenty-four
(24) hours of receipt of such information, notify the licensing agency of any
reportable event as defined in §
4.3 of this Part on a form
and in a manner specified by the Department.
2. 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 §§4.6.17(C)(5) through (6) of this
Part.
3. 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.
C. Reportable Incidents
1. The hospital shall ensure that any
employee who has reasonable cause to believe a reportable incident, as defined
in §
4.3 of this Part, has
occurred reports such information to a high managerial agent within twenty-four
(24) hours of receipt of such information on a form and in a manner specified
by the Department.
2. The hospital
must maintain records of such reports including all subsequent actions
taken.
3. 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.
4. Written report shall be in compliance with
§4.9.1 of this Part and shall include a patient medical record number but
no personal identifier.
5. 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.
6. If findings conclude that the incident was
not within said normal range, the hospital shall conduct a root cause analysis
or other appropriate process for incident investigation to identify causal
factors that may have led to the incident and shall develop a performance
improvement plan to prevent similar incidents from occurring in the future. The
hospital shall 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;
d. a summary of all actions taken to correct
identified problems to prevent recurrence of the incident and/or improve
overall patient care; and
e. a copy
of the performance improvement plan developed as a result of the incident
investigation.
D. Other Reporting Requirements
1. 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,
21 U.S.C. §
360i (2017).
2. The hospital shall report within 24 hours,
to the licensing agency, allegations of patient abuse, neglect or mistreatment
as defined in R.I. Gen. Laws Chapter
23-17-8.
4.6.18
Social
Services
A. Every hospital shall
provide social services within the scope of a defined plan.
B. A social worker qualified on the basis of
education, training and experience in accordance with the provisions of R.I.
Gen. Laws Chapter 5-39.1 shall supervise the delivery of social services on a
full, part-time, or consultative basis.
C. The service shall be staffed by a
sufficient number of social workers, qualified on the basis of education,
training and experience in accordance with the provisions of R.I. Gen. Laws
Chapter 5-39.1.
D. Appropriate
records shall be maintained and included in the patient's medical record.
4.6.19
Surgical
Service
A. Hospitals in which surgery
is performed shall maintain an operating suite and a surgical
department/service.
B. The surgical
department/service shall be governed under rules and regulations which include
surgical staff privileges, supporting services of other professional and
paramedical personnel, provisions for emergency coverage and operating suite
procedures, including standards of Rules and Regulations for the Termination of
Pregnancy (Part
20-10-6 of this
Title).
C. The operating suite
shall be:
1. under the supervision of a
person qualified by training and experience in operating room
service;
2. adequately designed, to
include operating and recovery rooms, proper scrubbing, sterilization and
dressing room facilities, storage for anesthetic agents and shall be adequately
equipped as required by the scope and complexity of services;
3. in compliance with safety requirements of
section 5.1.14.1.1 NFPA 99: Health Care Facilities Code, incorporated above at
§
4.2(A)(14) of this Part, and all other codes and
regulations of §§4.7.4 and 4.8.1(A) of this Part; and
4. provided with prominently posted policies
and procedures pertaining to safety controls.
D. A roster of current surgical privileges of
every surgical staff member shall be maintained on file in the operating
suite.
E. An operating room
register shall be maintained which shall include as a minimum: patient's name,
hospital number; pre- and post-operative diagnosis; complications, if any; name
of surgeon; first assistant, anesthetist, scrub and circulating nurse;
operation performed; and type of anesthesia.
F. The medical staff shall develop a policy
acceptable to the Director identifying which tissue/specimens removed at
surgery shall be submitted for pathological examination.
G. Policies and procedures governing
infection control and reporting techniques shall be established in accordance
with §4.7.2(A)(4) of this Part.
H. The patient's medical record shall be
available in the surgical suite at time of surgery and shall contain no less
than the following information which shall be documented prior to surgery:
1. a medical history, physical examination
and laboratory studies in accordance with §4.6.2(C) of this
Part;
2. a signed consent for
surgical procedure except in emergencies; and
3. a pre-operative diagnosis.
I. An accurate and complete
description of operative procedure including post-operative diagnosis shall be
recorded by the operating surgeon within 48 hours following completion of
surgery.
4.6.20
Anesthesia Service
A. In
hospitals with an anesthesia department/service, said department/service shall
be under the direction of a board-certified anesthesiologist and shall be
organized under written policies and procedures regarding staff privileges,
emergency coverage on a twenty-four (24) hour basis, the administration of
anesthetics, the maintenance of safety controls and qualifications and
supervision of non-physician anesthetists and trainees.
B. Policies shall include provisions, in
addition to the above, for the following:
1.
pre-anesthesia evaluation by a physician;
2. safety of the patient during the
anesthesia period;
3. review of
patient's condition prior to induction of anesthesia and post anesthetic
evaluation;
4. recording of all
events related to each phase of anesthesia care, including the development of
an intraoperative anesthesia record; and
5. the administration of anesthetics,
including conscious sedation, in any setting in the hospital.
C. With respect to inpatients, a
post-anesthesia evaluation shall be documented within forty-eight (48) hours
after surgery by the individual who administered the anesthesia. If the person
who administered the anesthesia is on leave (e.g., holiday, vacation, sick), an
exception to this requirement shall be permitted.
D. With respect to outpatients, a
post-anesthesia evaluation to assess proper anesthesia recovery shall be
performed prior to discharge. All post-anesthesia evaluations shall be
performed by the individual who administered the anesthesia or another
qualified anesthesia provider.
E.
Anesthesia shall only be administered by:
1. a
qualified anesthesiologist;
2. a
doctor of medicine or osteopathy (other than an anesthesiologist);
3. a dentist, oral surgeon, or podiatrist who
is qualified to administer anesthesia under state law or regulation;
4. a certified registered nurse anesthetist
(CRNA) acting within his/her scope of practice and as authorized by the
governing body;
5. a physician
assistant acting within his/her scope of practice and as authorized by the
governing body;
6. a certified
nurse-midwife acting within his/her scope of practice and as authorized by the
governing body;
7. a certified
registered nurse practitioner acting within his/her scope of practice and as
authorized by the governing body.
4.6.21
Obstetric Service
A. Hospitals with an obstetric service shall
provide adequate and comprehensive care to mothers and their newborn infants in
an environment which provides protection from infection and
cross-infection.
B. Written
policies and procedures shall be developed to cover alternative use of
obstetrical beds. These may include, but need not be restricted to patients
undergoing "clean" gynecologic surgery.
C. The obstetric unit shall be under the
general supervision of a registered nurse with training and experience in
obstetric nursing.
D. The practice
of midwifery shall be governed by the statutory and regulatory provisions of
"Rules and Regulations for Licensing of Midwives;" all policies, procedures and
protocols shall be approved by the medical staff and the governing
body.
E. Hospitals with an
obstetric service shall have no less than the following supportive services
available on a twenty-four (24) hour basis:
1. diagnostic x-ray;
2. blood or blood component transfusion
service;
3. clinical laboratory;
and
4. anesthesia service in
accordance with §4.6.20 of this Part.
F. Satisfactory provisions shall be made for
the care of patients in labor in adequately equipped labor rooms, conveniently
located to the delivery room.
G.
The delivery room(s) shall be of sufficient number and size to accommodate
expected case load, personnel and equipment.
H. The delivery room shall meet applicable
codes and regulations §§4.8.1 through 4.8.2 of this Part.
I. Hospitals performing both surgery and
obstetric services shall maintain individually identified surgical and
obstetric suites. Shared overflow facilities may be considered under special
circumstances with advance approval of the licensing agency.
J. Provisions shall be made within the
delivery area for the immediate care of emergencies with all necessary
emergency equipment available.
K.
An acceptable method and procedure shall be established for the positive
associative identification of mother and child in the delivery room.
L. Facilities shall be available and policies
and procedures established for maternity patients requiring isolation in
accordance with §4.7.2 of this Part.
M. A medical record shall be maintained for
each mother and newborn and the applicable standards of Standards for
Obstetric-Gynecological Services, incorporated above at §
4.2(A)(22)
of this Part, shall serve as guidelines in determining minimum content.
1. A record of any prenatal care rendered
shall be on file at the hospital and become part of the patient's medical
record.
N. Where not
otherwise covered in these regulations, the standards of Standards for
Obstetric-Gynecological Services, incorporated above at §
4.2(A)(22)
of this Part, shall serve as a guide in defining adequacy of the practices,
facilities and equipment in the obstetric unit.
O. A policy and procedure manual shall be
established which contains guidelines specifically related to the
administration and management of clinical services pertaining to no less than
the following:
1. definition of the limits of
practice and services provided;
2.
a signed informed consent which attests to the patient's full awareness of the
type of services provided, and the hospital's recognition of parental choice
for specific care services, except in emergency situations and provisions
required by law;
3. the orientation
and childbirth education program for expectant mothers;
4. plan of care to be developed by staff with
the participation of the patient; such plan shall be mutually acceptable to the
patient and staff but must include those provisions required by law.
Furthermore, the plan shall identify parental choices pertaining to such
services as the use of anesthesia; breast-feeding; circumcision of newborn
male; and need for postpartum supportive services;
5. medical consultation (pediatric, OB/GYN or
other);
6. the use of controlled
substances;
7. accessibility to
diagnostic services including laboratory, sonography, medical imaging,
electronic monitoring, intensive care;
8. permitting the attendance of partners
and/or family members during labor and delivery;
9. postpartum care based on acceptable
standards for follow-up and evaluation after discharge which includes no less
than:
a. provisions for the immediate
postpartum care and assessment of newborn; eye prophylaxis to newborn; Rhogam
test; metabolic screening and other tests for the newborn as may be required by
law; postpartum examination; assessment of mother-child relationship including
breast-feeding; follow-up care and family planning; preparation and submission
of birth certificates; instruction in child care; immunizations and such other
intrapartum and postpartum care as may be appropriate; and
10. such other as may be deemed necessary and
appropriate.
P. Mothers
may be discharged only if prenatal, perinatal and infant risk factors have been
identified and documented according to the perinatal screening protocol of the
Department (see §
4.10 of this Part) and the
discharge plan includes confirmed arrangements for appropriate home and
community follow-up services to address those risks. (See also
§§4.6.22(G), (H), (J) and (N) of this Part).
4.6.22
Newborn Service
A. Hospitals with a newborn service shall
have a registered nurse with experience in the care of the newborn and shall be
responsible for the nursing care of newborn infants. The appropriate nursing
personnel shall be present in the nursery at all times.
B. Access to the nursery shall be limited to
parents and personnel who are immediately concerned with the care of the
newborn and the nursery environment and who are free of communicable
infections.
C. The nursery shall be
located and arranged to provide complete protection of newborn infants from
infection and cross-infection and nursery accommodations shall include but
shall not be limited to:
1. A regular nursery
for the care of healthy infants, excluding:
a. infants with transmissible
disease;
b. infants born to a
mother who is a carrier or is infected by transmissible disease;
c. infants born outside the hospital or
readmitted with suspected transmissible disease;
d. infants who are exposed to or have been
infected; and
e. other infants
excluded by the medical staff.
2. An isolation facility for the care of
newborn infants with a suspected or confirmed diagnosis of infection.
3. A premature nursery for the care of
premature infants or other high risk and seriously ill infants with
non-infectious conditions. Vigorous healthy premature infants may be cared for
in their own protected environment, such as in a standard incubator in the
regular nursery.
D. A
defined policy for the care of infants born outside the hospital, for infants
born of a mother who has had no prenatal care, or for infants suspected of
harboring an infectious disease.
E.
The ventilation system shall maintain positive pressure in the nursery and
shall be installed in accordance with section 7.31 of Guidelines for Design and
Construction of Hospital and Health Care Facilities, incorporated above at
§
4.2(A)(10) of this Part.
F. Prophylactic treatment to the eyes of
newborn infants shall be administered in accordance with R.I. Gen. Laws §
23-13-4.
G. The physician attending a newborn child
shall cause said child to be subject to the tests listed in the Rules and
Regulations Pertaining to the Newborn Metabolic, Endocrine, and
Hemoglobinopathy Screening Program (Part 20-05-1 of this Title).
H. An adequate record of the pertinent facts
of the gestation and immediate neonatal period shall accompany the infant to
the nursery and become part of the infant's medical record and may be used to
assist in conducting risk assessments for discharge planning and public health
services.
I. Where otherwise not
covered in these regulations, the standards of Standards and Recommendations
for Hospital Care of Newborn Infants, incorporated above at §
4.2(A)(20)
of this Part, shall serve as a guide in defining the adequacy of facilities,
equipment, furnishings and practices in the newborn nursery and formula
room.
J. Hospital staff shall
develop a multidisciplinary discharge plan for any drug exposed baby, pursuant
to R.I. Gen. Laws §
42-72-5.
K. Infants may be discharged only if
prenatal, perinatal and infant risk factors have been identified and documented
according to the perinatal screening protocol of the Department (see §
4.10 of this Part) and the
discharge plan includes confirmed arrangements for appropriate home and
community follow-up services to address those risks. (See also
§§4.6.22(G), (H), (J) and (N) of this Part.)
L. Each hospital that provides
newborn/obstetrical services shall report to the Department the following data
for each fiscal year:
1. the number of
births;
2. the number of very low
birth weight neonates (501 -1500 grams);
3. the number of low birth weight neonates
(1501 - 2500 grams);
4. neonatal
mortality rates by birth weight class;
5. admissions and transfers to neonatal
intensive care units.
M.
Each hospital that provides newborn/obstetrical services shall maintain records
of morbidity rates of neonates for nosocomial infections, necrotizing
enterocolitis, bronchopulmonary dysplasia, and intraventricular
hemorrhage.
N. Each hospital that
provides newborn/obstetrical services 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
§4.6.22(M) of this Part. If the survival rate for the hospital's newborn
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 newborn unit shall file a written plan with the Department
for the identification of the cause(s) of excess mortality and a plan for
correction, if indicated.
4.6.23
Birth Center Service
A. Hospitals with an obstetric service may
elect to have a birth center service as defined in §
4.3 of this Part. An
organizational structure for such service shall be designed in accordance with
§4.5.6 of this Part.
B. The
birth center service shall be under the direction of a medical director who is
a board certified obstetrician/gynecologist, with full obstetrical privileges,
and who shall be responsible for all the clinical and medical matters
pertaining to the management of pregnancy, birth, postpartum, newborn and
gynecological health care of low-risk women, including the approval of written
policies and procedures and protocols for midwifery care management where
appropriate and applicable.
1. "Low-Risk"
refers to expected normal, uncomplicated prenatal course, assisted by adequate
prenatal care and prospects for a normal uncomplicated birth based on continual
screening for high risk factors which would preclude admission to the center,
or require referral and/or transfer from the center in accordance with the
transfer policies pursuant to §4.6.1(A)(6) of this
Part.
C. A midwife
licensed in this state or a physician with obstetric privileges may be
designated to direct the administrative operation of the center and the
management of clinical services.
D.
An appropriate number of qualified professionals and ancillary personnel shall
be assigned to the birth center service. Two (2) staff members shall be in
attendance at each birth, one of the two shall be a physician with hospital
obstetric privileges or a midwife with delivery privileges and licensed in this
state. The other member may be a licensed midwife with delivery privileges, an
obstetric physician, or licensed physician assistant with training and
experience in obstetric care and resuscitation of the newborn, or a licensed
nurse with training and experience in obstetric care and resuscitation of the
newborn.
1. The practice of midwifery shall
be governed by the statutory and regulatory provisions of "Rules and
Regulations for Licensing of Midwives;" all policies, procedures and protocols
shall be approved by the medical director and the governing body.
2. There shall be on the premises at all
times, when a woman is in labor, a staff person who holds a current certificate
in cardiopulmonary resuscitation from a recognized program such as the American
Heart Association.
3. Whenever one
or more women in labor are on the premises, there shall be one staff member in
excess to the number of women in labor.
E. A policy and procedure manual shall be
established which contains guidelines specifically related to the
administration and management of clinical services pertaining to no less than
the following:
1. definition of the limits of
practice and services provided;
2.
the criteria for the selection of clients based on established medical and
social risk factors associated with possible poor outcomes and utilizing as
guidelines no less than the risk factors of "Rules and Regulations for
Licensing Birth Centers," which would preclude admission to the
center;
3. the criteria for the
referral and/or transfer of clients and/or newborn utilizing as guidelines the
high risk factors of "Rules and Regulations for Licensing Birth
Centers;"
4. a signed informed
consent which attests to the client's full awareness of the type of services
provided at the birth center, and the birth center's recognition of parental
choice for specific care services, except in emergency situations and
provisions required by law;
5. the
orientation and childbirth education program for expectant mothers, based on
the provisions of "Rules and Regulations for Licensing Birth
Centers;"
6. plan of care to be
developed by staff with the participation of the client; such plan shall be
mutually acceptable to the client and staff but must include those provisions
required by law. Furthermore, the plan shall identify parental choices
pertaining to such services as the use of anesthesia in accordance with "Rules
and Regulations for Licensing Birth Centers;" breast-feeding, circumcision of
newborn male, and need for postpartum supportive services. Such plan shall be
based on the provisions of "Rules and Regulations for Licensing Birth
Centers;"
7. prenatal care to be
provided either directly at the birth center or in another setting as approved
by the medical director and the governing body; and provided, the professional
staff providing the prenatal care meets the staff requirements of these
regulations, and policies are established by the medical director governing the
prenatal care practices and admission criteria of a woman in active labor,
which are consistent with the birth center services practice;
8. medical consultation (pediatric, OB/GYN or
other);
9. the use of controlled
substance;
10. the use of
anesthesia in accordance with "Rules and Regulations for Licensing Birth
Centers;"
11. accessibility to
diagnostic services including laboratory, sonography, medical imaging,
electronic monitoring, intensive care;
12. labor and delivery (including provisions
pertaining to §4.4.4(A)(1) of this Part);
13. permitting the attendance of partners
and/or family members during labor and delivery;
14. the provision of services on a
twenty-four (24) hour basis;
15.
postpartum care based on acceptable standards for follow-up programs of care
and postpartum evaluation after discharge which includes no less than:
a. discharge of mother and newborn generally
within twenty-four (24) hours after birth;
b. accessibility by telephone, twenty-four
(24) hours a day of center's physician, midwife or nurse to assist mothers in
case of need during postpartum period;
c. home visitation within twenty-four (24)
hours of discharge by a member of the center's professional staff to insure
continuity of care and assessment of mother and newborn;
d. provisions for the immediate postpartum
care and assessment of newborn; eye prophylaxis to newborn; Rhogam test;
metabolic screening and other tests for the newborn as may be required by law;
postpartum examination; assessment of mother-child relationship including
breast-feeding; follow-up care and family planning; preparation and submission
of birth certificates; instruction in child care; immunizations and such other
intrapartum and postpartum care as may be appropriate; and
16. such other as may be deemed necessary and
appropriate.
F. A
mechanism shall be established for the systematic review of professional and
administrative services and the quality improvement program.
G. A clinical record shall be maintained for
every client and newborn in accordance with the appropriate provisions of
§4.6.10 of this Part.
H. Food
Services
Provisions shall be made for the availability of
appropriate nourishments and light snacks for clients and family
members.
I. Physical Setting
and Equipment
Birth center service shall be provided in a home-like
environment, designated and equipped to protect the health and safety of
clients and personnel, and to facilitate emergency exit for the transfer of
mothers and/or newborns in the event of emergency.
1. Reception areas, examination room, family
rooms and other supportive areas shall be provided and designed to give privacy
and comfort to clients and their families.
2. The birth room shall be spacious enough to
accommodate staff to move freely and to include at least:
a. a large bed or double bed;
b. chairs (lounge and
straight-back);
c. a
bassinet;
d. space for birth room
supplies and equipment and family belongings; and
e. access to a sink with hot and cold running
water with elbow-wrist controls.
3. Acceptable toilet facilities shall be
available to each laboring woman and adequate shower facilities shall also be
available.
4. Provisions shall be
made for areas such as medication and storage areas, utility areas and such
others as may be necessary.
5.
Equipment in the birth center shall be limited to those items needed to provide
low risk maternity care and shall include equipment to initiate emergency
procedures in life threatening events to mothers and newborns. Such equipment
shall include:
a. oxygen and positive pressure
masks;
b. delee trap suction and
infant laryngoscope and airways;
c.
IV equipment;
d. blood
expanders;
e. medications
identified in protocols for emergency needs; and
f. infant transport equipment and infant
warmers.
J.
Mothers and infants may be discharged only if prenatal, perinatal and infant
risk factors have been identified and documented according to the perinatal
screening protocol of the Department (see §
4.10 of this Part) and the
discharge plan includes confirmed arrangements for appropriate home and
community follow-up services to address those risks. (See also
§§4.6.22(G), (H), (J) and (N) of this Part.)
4.6.24
Tertiary Care Services: Neonatal
Intensive Care Units (NICUs)
A.
Approval to Operate a NICU and General Requirements
1. In order to use the designation "neonatal
intensive care unit" or "NICU", a hospital shall obtain approval from the
Department's Center for Health Facility Regulations. Said approval shall be
issued by the Department if the NICU meets the requirements defined in these
regulations.
a. Each hospital shall renew
this NICU designation annually.
2. Upon satisfactory review of all requested
documentation and upon the determination that the hospital has achieved the
volume/quality standards described in these regulations, the Department shall
approve the hospital's designation as a NICU.
3. A hospital that has not received approval
by the Department under this section shall not use the designation "neonatal
intensive care unit" or "NICU" or any substantially similar phrase to describe
any such services provided and shall not provide neonatal intensive care unit
services.
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 §§4.6.24(D), (E),
and (F) of this Part. 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.
5. A hospital that operates a NICU and
determines that the NICU no longer meets minimum standards of these regulations
shall notify the Department of Health and file a plan of correction within
fifteen (15) days of such determination by a hospital. The plan of correction
shall be subject to §4.9.3 of this Part.
6. A NICU shall provide consultation,
transportation, and professional educational offerings to staff of other
obstetrical facilities in the state.
7. 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.
B. Minimum Standards: Volume
1. An existing neonatal intensive care unit
shall maintain an average daily census of at least fifteen (15)
neonates.
2. 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.
3. 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.
C. Minimum Standards: Survival Rates
1. 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).
2. Each hospital shall
maintain records of morbidity rates of neonates for nosocomial infections,
necrotizing enterocolitis, bronchopulmonary dysplasia, and intraventricular
hemorrhage.
3. 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 §4.6.24(C)(2) of this Part. 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.
D. Staffing Requirements
1. 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.
E. Service Requirements
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:
1.
twenty-four (24) hour emergency transport team for transferring sick newborns
from the birth facility to the neonatal intensive care unit;
2. ventilatory assistance and/or complex
respiratory management;
3.
capability of continuous intravenous administration of vasopressor
agents;
4. insertion and
maintenance of all types of venous and arterial lines;
5. phototherapy;
6. exchange transfusions;
7. continuous cardiorespiratory
monitoring;
8. complex nutritional
and metabolic management including total parenteral nutrition;
9. extensive pediatric radiology, diagnostic
imaging, and subspecialty services;
10. full range of laboratory services
including microchemistry available on a twenty-four (24) hour basis;
11. pharmacy services experienced in neonatal
medications and dosage;
12.
surgical therapies and post-surgical care for the neonate;
13. access to pediatric subspecialty
consultation;
14. availability of
developmental consultation;
15.
organized interdisciplinary process for continuous quality
monitoring;
16. crisis-oriented
support and ongoing psychosocial services, including social work services and
the availability of psychiatric consultation for the parents of the
neonate.
F. Equipment
Requirements
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:
1. incubators;
2. cardiorespiratory monitors with high/low
alarm and oximeters;
3. warming
tables;
4. infusion
pumps;
5. oxygen humidification and
warming systems;
6. oxygen
analyzer;
7. transcutaneous blood
gas monitors;
8. arterial and
venous catheterization equipment;
9. resuscitation and other life support
medications and equipment;
10.
ventilators with heated humidity and alarm systems;
11. transducers for invasive cardiac
monitoring;
12. transport
incubators.
G. Penalties
for Noncompliance
The penalties for violations of the standards set forth in
§4.6.24 of this Part shall be in accordance with those set forth in R.I.
Gen. Laws Chapter 23-17 and §4.4.6 of this Part. Failure to maintain the
minimal neonatal intensive care unit standards set forth in these regulations
may result in the revocation or suspension of the hospital's neonatal intensive
care unit designation and/or cessation of its activities. A hospital shall post
notices for patients and shall notify physicians if its designation as an
approved neonatal intensive care unit has been revoked or suspended.
4.6.25
Tertiary Care Services: Primary
and/or Elective Percutaneous Coronary Intervention Programs
A. Approval to Operate a Primary and/or
Elective Percutaneous Coronary Intervention Program and General Requirements
1. In order to use the designation "primary
percutaneous coronary intervention program" and/or "elective percutaneous
coronary intervention program," a hospital shall obtain approval from the
Department's Center for Health Facility Regulations. Said approval shall be
issued by the Department if the primary and/or elective percutaneous coronary
intervention program meets the requirements defined in these regulations.
a. Each hospital shall renew primary and/or
elective percutaneous coronary intervention program designation
annually.
2. Upon
satisfactory review of all requested documentation and upon the determination
that the hospital has achieved the volume/quality standards described in these
regulations, the Department shall approve the hospital's designation as a
primary and/or elective percutaneous coronary intervention program.
3. A hospital that has not received approval
by the Department under this section shall not use the designation "primary
percutaneous coronary intervention program," or "elective percutaneous coronary
intervention program," or any substantially similar phrase, to describe any
such services provided and shall not perform primary and/or elective
percutaneous coronary interventions.
4. A hospital that operates a primary and/or
elective percutaneous coronary intervention program approved by the Department
shall maintain capabilities and provide services that include, but are not
limited to, those capabilities and services described in §§4.6.25(D),
(E), (F) of this Part. A hospital that operates a primary and/or elective
percutaneous coronary intervention 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.
5. A hospital that
operates a primary and/or elective percutaneous coronary intervention program
and determines that primary and/or elective percutaneous coronary intervention
program no longer meets minimum standards of these regulations shall notify the
Department of Health and file a plan of correction within fifteen (15) days of
such determination by a hospital. The plan of correction shall be subject to
the provisions of §4.9.3 of this Part.
6. A hospital that operates an approved
elective percutaneous coronary intervention program shall have an approved
primary percutaneous coronary intervention program available on-site.
B. Minimum Standards: Volume
1. An existing primary percutaneous coronary
intervention program shall maintain an annual minimum volume of at least
thirty-six (36) primary percutaneous coronary intervention
procedures.
2. An existing elective
percutaneous coronary intervention program shall maintain an annual minimum
volume of at least two hundred (200) percutaneous coronary intervention
procedures.
3. As part of the
approval process for a new (or proposed) primary percutaneous coronary
intervention program, the hospital shall provide data to the Department
demonstrating a reasonable expectation of attaining and maintaining a minimum
volume of thirty-six (36) primary percutaneous coronary intervention procedures
per year within one (1) year of its opening date.
4. As part of the approval process for a new
(or proposed) elective percutaneous coronary intervention program, the hospital
shall provide data to the Department demonstrating a reasonable expectation of
attaining and maintaining a minimum volume of two hundred (200) elective
angioplasty procedures per year within two (2) years of its opening
date.
5. As part of the approval
process for a new (or proposed) primary percutaneous coronary intervention
program, the hospital shall also provide any available data to the Department
regarding whether the addition of the proposed primary coronary angioplasty
program is likely to result in the annual volume of procedures performed by
existing primary percutaneous coronary intervention programs falling below
thirty-six (36) primary percutaneous coronary intervention procedures per year.
If this outcome is likely, the proposal shall describe how the overall quality
of care for all primary percutaneous coronary intervention patients in the
state will be improved with the addition of the proposed program.
6. As part of the approval process for a new
(or proposed) elective percutaneous coronary intervention program, the hospital
shall also provide any available data to the Department regarding whether the
addition of the proposed elective percutaneous coronary intervention program is
likely to result in the annual volume of procedures performed by existing
elective percutaneous coronary intervention programs falling below two hundred
(200) percutaneous coronary intervention procedures per year. If this outcome
is likely, the proposal shall describe how the overall quality of care for all
elective percutaneous coronary intervention patients in the state will be
improved with the addition of the proposed program.
C. Minimum Standards: Survival Rates and
Door-to-Balloon Times
1. Each hospital that
has an approved primary and/or elective percutaneous coronary intervention
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 percutaneous coronary intervention
procedures.
2. Each hospital that
has an approved primary and/or elective percutaneous coronary intervention
program shall participate in a nationally recognized database acceptable to the
Director. To the extent possible, risk adjusted rates, based on data from
nationally recognized databases and methods acceptable to the Director, shall
be used.
3. Each hospital that has
an approved primary percutaneous coronary intervention program shall maintain a
record of door-to-balloon times for each patient.
4. Each hospital shall report the following
data to the Department annually:
a. the
emergency coronary artery bypass (CABG) rate for patients having percutaneous
coronary intervention;
b. the
hospital's risk-adjusted PCI mortality rate, based on a nationally recognized
database and methods acceptable to the Director;
c. the 95% confidence interval around the
hospital's PCI mortality rate;
d.
the national average PCI mortality rate from the national PCI database in which
the hospital participates; and
e.
the 95% confidence interval around the national PCI mortality rate. If the
hospital's annual risk-adjusted PCI mortality rate is statistically
significantly higher than the national rate at the 95% level of confidence,
then the hospital shall file a corrective action plan.
D. Staffing Requirements
A hospital that operates a primary and/or elective
percutaneous coronary intervention program approved by the Department shall be
in compliance with the following staffing requirements:
1. A board-certified cardiologist licensed in
Rhode Island shall be designated as the director of the cardiac catheterization
laboratory that includes the primary and/or elective percutaneous coronary
intervention program.
2. Physicians
doing primary and/or elective percutaneous coronary intervention procedures
shall have training in adult or pediatric interventional cardiology,
3. Each hospital that has an approved primary
and/or elective percutaneous coronary intervention 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.
4. The hospital shall
monitor annual procedural volume, complication rates, emergency CABG rates, and
inhospital mortality for each operator.
a.
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.
5.
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.
6. 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.
7. Physicians
performing primary percutaneous coronary intervention procedures shall have an
annual minimum volume of at least seventy-five (75) percutaneous coronary
intervention procedures of which at least eleven (11) are primary percutaneous
coronary intervention procedures across all hospitals where he/she practices
and has privileges.
8. Physicians
performing elective percutaneous coronary intervention procedures shall have an
annual minimum volume of at least seventy-five (75) percutaneous coronary
intervention procedures across all hospitals where he/she practices and has
privileges.
E. Service
Requirements for Primary and/or Elective Percutaneous Coronary Intervention
Programs Without On-Site Coronary Artery Bypass Graft Surgery Program
1. A hospital that operates an approved
primary and/or elective percutaneous coronary intervention program without
on-site coronary artery bypass graft surgery program shall establish a
memorandum of understanding, acceptable to the Director, with a hospital that
has an on-site coronary artery bypass graft surgery program for transfer of
patients requiring emergency cardiac surgery.
2. A hospital that operates an approved
primary and/or elective percutaneous coronary intervention program without
on-site coronary artery bypass graft surgery program shall develop rapid
transfer protocols, acceptable to the Director, with the area emergency medical
services provider for transfer of patients requiring emergency cardiac
surgery.
F. Equipment
Requirements
A hospital that operates a primary and/or elective
percutaneous coronary intervention 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.
G. Quality of Care
1. The primary and/or elective percutaneous
coronary intervention program shall have regular, frequent, and formal review
in a multidisciplinary conference of all deaths and major
complications.
2. The primary
and/or elective percutaneous coronary intervention 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.
H. Reporting Requirements
Each hospital with an approved primary and/or elective
percutaneous coronary intervention program shall report to the Department for
each hospital calendar year:
1. the
number of primary and/or elective percutaneous coronary intervention
procedures;
2. the number of
primary and/or elective percutaneous coronary intervention by primary operator
and the number of transfers from another hospital;
3. the number of emergency coronary artery
bypass graft surgeries in the same hospital stay following primary and/or
elective percutaneous coronary intervention procedures;
4. the number of transfers to another
hospital for emergency coronary artery bypass graft surgeries following a
primary and/or elective percutaneous coronary intervention;
5. the inhospital mortality rate for primary
and/or elective percutaneous coronary intervention patients;
6. the number of primary and/or elective
percutaneous coronary intervention procedures by indication for performing the
procedure;
7. the door-to-balloon
times for primary percutaneous coronary intervention procedures; and
8. such other data as specified by the
Director.
I. Penalties
for Noncompliance
The penalties for violations of the standards set forth in
§4.6.25 of this Part shall be in accordance with those set forth in R.I.
Gen. Laws Chapter 23-17, and §4.4.6 of this Part. Failure to maintain the
minimal primary and/or elective percutaneous coronary intervention program
standards set forth in these regulations may result in the revocation or
suspension of the hospital's primary and/or elective percutaneous coronary
intervention program designation and/or cessation of its activities. A hospital
shall post notices for patients and notify physicians if its designation as an
approved primary and/or elective percutaneous coronary intervention program has
been revoked or suspended.
4.6.26
Tertiary Care Services: Coronary
Artery Bypass Graft Surgical Programs
A. Approval to Operate a Coronary Artery
Bypass Graft Surgical Program and General Requirements
1. In order to use the designation "coronary
artery bypass graft surgical program," a hospital shall obtain approval from
the Department's Center for Health Facility Regulations. Said approval shall be
issued by the Department if the coronary artery bypass graft surgical program
meets the requirements defined in these regulations.
a. Each hospital shall renew this coronary
artery bypass graft surgical program designation annually.
2. Upon satisfactory review of all requested
documentation and upon the determination that the hospital has achieved the
volume/quality standards described in these regulations, the Department shall
approve the hospital's designation as a coronary artery bypass graft surgical
program.
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.
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 §§4.6.26(D), (E) and (F) of
this Part. 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.
5. A hospital that operates a coronary artery
bypass graft surgical program and determines the that coronary artery bypass
graft surgical program no longer meets minimum standards in these regulations
shall notify the Department and file a plan of correction within fifteen (15)
days of such determination by a hospital. The plan of correction shall be
subject to the provisions of §4.9.3 of this Part.
B. Minimum Standards: Volume
1. An existing coronary artery bypass graft
surgical program shall maintain an annual minimum volume of at least two
hundred and fifty (250) surgical patients 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.
2. 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
two (2) years of its opening date, of attaining and maintaining a minimum
volume of at least two hundred and fifty (250) surgical patients per year who
require the availability of cardiopulmonary bypass.
3. 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 two hundred and
fifty (250) 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.
C. Minimum
Standards: Survival Rates
1. 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 and shall participate in a nationally recognized
database acceptable to the Director. To the extent possible, risk adjusted
rates, based upon data from nationally recognized databases and methods
acceptable to the Director, shall be used.
2. Each hospital shall report the following
data to the Department annually:
a. the
hospital's risk-adjusted mortality rate for isolated CABG, based on a
nationally recognized database and methods acceptable to the Director;
b. the 95% confidence interval
around the hospital's isolated CABG mortality rate;
c. the national average isolated CABG
mortality rate from the national open heart surgery database in which the
hospital participates;
d. the 95%
confidence interval around the national isolated CABG mortality rate.
3. If the hospital's annual
risk-adjusted isolated CABG mortality rate is statistically significantly
higher than the national rate at the 95% level of confidence, 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
§4.9.3 of this Part.
D. Staffing Requirements
A hospital that operates a coronary artery bypass graft
surgical program approved by the Department shall be in compliance with the
following staffing requirements:
1. 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.
2. A hospital coronary artery bypass graft
surgical program should have a minimum of two (2) qualified cardiac
surgeons.
3. 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.
4. Other specially trained physicians
assisting the cardiac surgeon shall be cardiac surgical assistants, cardiac
anesthesiologists, cardiologists, and other qualified consultants.
5. Nursing personnel shall include surgical
nurses specially trained in cardiac surgical nursing, cardiac surgery intensive
care nursing, and cardiac nurse educators.
6. Perfusionists shall be trained in the
preparation, maintenance, and operation of pump-oxygenators 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.
7. 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.
E. Service Requirements
Coronary angiography of diagnostic quality shall be
available. Facilities that treat pediatric patients shall provide for biplane
angiography.
F. Equipment
Requirements
1. 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.
2. 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.
G. Quality of Care
1. The cardiac surgery program shall have
regular, frequent, and formal review in a multidisciplinary conference of all
deaths and major complications.
2.
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.
H.
Reporting Requirements
Each hospital with an approved coronary artery bypass graft
surgical program shall report to the Department for each hospital calendar
year:
1. the number of surgical
patients requiring cardiopulmonary bypass capability;
2. the number of coronary artery bypass graft
surgeries by principal surgeon;
3.
the number of emergency coronary artery bypass graft surgeries in the same
hospital stay following percutaneous coronary intervention;
4. the inhospital mortality rate for coronary
artery bypass graft surgical patients;
5. the number of coronary artery bypass graft
operations by indication for performing the surgery; and
6. such other data as specified by the
Director.
I. Penalties
for Noncompliance
The penalties for violations of the standards set forth in
§4.6.26 of this Part shall be in accordance with those set forth in R.I.
Gen. Laws Chapter 23-17 and §4.4.6 of this Part. Failure to maintain the
minimal coronary artery bypass graft surgical program standards set forth in
these regulations may result in the revocation or suspension of the hospital's
coronary artery bypass graft surgical program designation and/or cessation of
its activities. A hospital shall post notices for patients and shall notify
physicians if its designation as an approved coronary artery bypass graft
surgical program has been revoked or suspended.
4.6.27
Tertiary Care Services: Heart
and/or Liver Transplant Programs
A.
Approval to Operate a Heart and/or Liver Transplant Program and General
Requirements
1. In order to use the
designation "heart transplant program" or "liver transplant program", a
hospital shall obtain approval from the Department's Center for Health Facility
Regulations. Said approval shall be issued by the Department if the heart
and/or liver transplant program meets the requirements defined in these
regulations.
a. Each hospital shall renew
this heart and/or liver transplant program designation annually.
2. Upon satisfactory review of all
requested documentation and upon the determination that the hospital has
achieved the volume/quality standards described in these regulations, the
Department shall approve the hospital's designation as a heart and/or liver
transplant program.
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.
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 in these
regulations.
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).
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 regulations
for Reporting and Testing of Infectious, Environmental and Occupational
Diseases (Part 30-05-1 of this Title) and "Guidelines for Preventing
Transmission of HIV through Transplantation of Human Tissue and Organs,"
incorporated above at §
4.2(A)(18)
of this Part, for the prevention of HIV transmission.
7. A hospital that operates a heart and/or
liver transplant program and determines that the heart and/or liver transplant
program no longer meets minimum standards in these regulations shall notify the
Department of Health and file a plan of correction within fifteen (15) days of
such determination by a hospital. The plan of correction shall be subject to
the provisions of §4.9.3 of this Part.
B. Minimum Standards: Volume
1. A new or proposed heart transplant program
shall provide data showing a reasonable expectation of attaining and
maintaining a minimum volume 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.
2. A new or
proposed liver transplant program shall provide data showing a reasonable
expectation of attaining and maintaining a minimum volume 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.
C. Minimum Standards: Survival Rates
1. 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.
2. 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.
D. Quality of Care
1. 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 ("Bylaws," incorporated
above at §
4.2(A)(9) of
this Part).
2. 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.
3. 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.
E. Reporting
Requirements
Each hospital that provides heart transplantation and/or
liver transplantation services shall report to the Department for each hospital
fiscal year:
1. the number of heart
and/or liver transplants, respectively;
2. the number of heart and/or liver
transplants by principal surgeon;
3. the mortality rate for heart and/or liver
patients at three (3) months, one (1) year, and three (3) years.
F. Penalties for
Noncompliance
The penalties for violations of the standards set forth in
§4.6.27 of this Part shall be in accordance with those set forth in R.I.
Gen. Laws Chapter 23-17 and §4.4.6 of this Part. Failure to maintain the
minimal heart and/or liver transplant program standards set forth in these
regulations may result in the revocation or suspension of the hospital's heart
and/or liver transplant program designation and/or cessation of its activities.
The hospital shall post notices for patients and notify physicians if its
status as an approved heart and/or liver transplant program has been revoked or
suspended.
4.6.28
Tertiary Care
Services: Esophageal and/or Pancreatic Cancer Surgery Programs
A. Approval to Operate an Esophageal and/or
Pancreatic Cancer Surgery Programs and General Requirements
1. In order to use the designation
"Esophageal Cancer Surgery Program" and/or "Pancreatic Cancer Surgery Program,"
a hospital shall obtain approval from the Department's Center for Health
Facility Regulations. Said approval shall be issued by the Department if the
esophageal and/or pancreatic cancer surgery program meets the requirements
defined in these regulations.
a. Within six
(6) months of the effective date of these regulations, any hospital operating
an esophageal and/or pancreatic cancer surgery program shall file an
application with the Department for approval as a "Esophageal Cancer Surgery
Program" and/or "Pancreatic Cancer Surgery Program," as applicable.
b. Each hospital shall renew this esophageal
and/or pancreatic cancer surgery program designation annually.
2. Upon satisfactory review of all
requested documentation and upon the determination that the hospital has
achieved the volume/quality standards described in these regulations, the
Department shall approve the hospital's designation as esophageal and/or
pancreatic cancer surgery program.
3. A hospital that has not received approval
by the Department under this section shall not use the designation "Esophageal
Cancer Surgery Program" and/or "Pancreatic Cancer Surgery Program," or any
substantially similar phrase, to describe any such services provided and shall
not perform esophageal and/or pancreatic cancer surgery.
4. A hospital that operates an esophageal
and/or pancreatic cancer surgery program approved by the Department shall
maintain capabilities and provide services in accordance with the requirements
described in these regulations.
5.
A hospital that operates an esophageal and/or pancreatic cancer surgery program
and determines that the esophageal and/or pancreatic cancer surgery program no
longer meets minimum standards in these regulations shall notify the Department
and file a plan of correction within fifteen (15) days of such determination by
a hospital. The plan of correction shall be subject to the provisions of
§4.9.3 of this Part.
B. Minimum Standards: Volume
1. An existing esophageal cancer surgery
program approved by the Department shall maintain an annual minimum volume of
seven (7) operations.
2. An
existing pancreatic cancer surgery program approved by the Department shall
maintain an annual minimum volume of eleven (11) operations.
3. Each hospital that has an approved
esophageal and/or pancreatic cancer surgery program shall participate in a
nationally recognized database acceptable to the Director, if such database
exists. To the extent possible, risk adjusted rates, based on data from
nationally recognized databases and methods acceptable to the Director, shall
be used.
4. A new or proposed
esophageal cancer surgery program shall provide data to the Department showing
a reasonable expectation of attaining and maintaining a minimum volume of seven
(7) operations per year within two (2) years of its designation. It shall also
report whether the addition of the new esophageal cancer surgery program is
likely to result in the annual volume of operations performed by existing
esophageal cancer surgery programs falling below seven (7) operations per year.
If this outcome is likely, it will explain how the overall quality of care for
all esophageal cancer patients in the state will be improved by the addition of
the proposed program.
5. A new or
proposed pancreatic cancer surgery program shall provide data to the Department
showing a reasonable expectation of attaining and maintaining a minimum volume
of eleven (11) operations per year within two (2) years of its designation. It
shall also report whether the addition of the new pancreatic cancer surgery
program is likely to result in the annual volume of operations performed by
existing pancreatic cancer surgery programs falling below eleven (11)
operations per year. If this outcome is likely, it will explain how the overall
quality of care for all pancreatic cancer patients in the state will be
improved by the addition of the proposed program.
C. Reporting Requirements
Each hospital that provides esophageal cancer surgery
and/or pancreatic cancer surgery shall report to the Department for each
hospital fiscal year:
1. the number of
esophageal and/or pancreatic cancer operations, respectively;
2. the number of esophageal and/or pancreatic
cancer operations by principal surgeon;
3. the mortality rate for esophageal and/or
pancreatic cancer patients at three (3) months, and the readmission
rates.
D. Penalties for
Noncompliance
The penalties for violations of the standards set forth in
§4.6.28 of this Part shall be in accordance with those set forth in R.I.
Gen. Laws Chapter 23-17, and §4.4.6 of this Part. Failure to maintain the
minimal esophageal and/or pancreatic cancer surgery program standards set forth
in these regulations may result in the revocation or suspension of the
hospital's esophageal and/or pancreatic cancer surgery program designation
and/or cessation of its activities. The hospital shall post notices for
patients and shall notify physicians, if its status as an approved esophageal
and/or pancreatic cancer surgery program has been revoked or
suspended.
4.6.29
Special Care Units
A. As used in
this section, special care units may be multi-purpose or include but not be
limited to units for: burn, critical care, observation, pulmonary care,
rehabilitation and hemodialysis.
B.
Special care units shall have a defined organization and shall be integrated
with other departments and services of the hospital.
C. The units shall be designed and equipped
for the defined special functions with provisions for effectiveness and safety
in operation.
D. Hospitals shall
develop and define standards for the operation of the specialized
units.
E. The services shall be
governed by written policies and procedures specifically defining admission and
discharge criteria.
F. Each unit
shall be under the direction of a physician qualified by training and
experience in the specialty care.
G. A sufficient number of specially qualified
personnel shall be provided based on the scope and complexity of the services
provided.
H. There shall be
specific written policies defining the scope of responsibilities assigned to
staff personnel.
I. A continuing
education program developed specifically for personnel of special care units
shall be provided to insure an optimum level of skills and
performance.
4.6.30
Psychiatric Service
A. Hospitals
with psychiatric services shall have such services under the supervision of a
clinical director who is certified by the American Board of Psychiatry and
Neurology or who has equivalent training and experience.
B. There shall be a sufficient number of
qualified professional, technical and supporting personnel and consultants to
carry out a diagnostic and treatment program that includes no less than:
1. the evaluation of individual needs of
patients; and
2. the establishment
and implementation of written treatment and rehabilitation plans involving
psychiatric, medical, surgical, nursing, social work, psychological therapies
and other such services.
C. Medical records shall include:
1. patient's legal status;
2. psychiatric diagnosis as well as diagnoses
of intercurrent diseases;
3.
psychiatric evaluation which includes a medical history, records mental status,
notes onset of illness and circumstances leading to admission, describes
attitude and behaviors, and estimates intellectual and cognitive functioning,
memory functioning and orientation;
4. complete neurological examination when
indicated;
5. social service
records of interviews with patient, family and others, assessments of home
plans, contacts with community resources, as well as a social
history;
6. treatment plans that
include measurable goals and specific treatment modalities to be
utilized;
7. documentation of all
treatment provided;
8. at least
weekly progress notes, by the physician, physician assistant, nurse, social
worker, and when appropriate, others significantly involved in treatment, that
provide an assessment of the patient's progress in accordance with the
treatment plan;
9. discharge
summary and aftercare plan.
D. Hospitals with psychiatric services shall
maintain patient-identifiable information in confidence in accordance with all
applicable state and federal statutes and regulations, including, but not
limited to, R.I. Gen. Laws Chapter 40.1-5 ("Mental Health Law").
E. In addition to the above, the requirements
of §4.6.29 of this Part and all applicable sections of these regulations
shall apply to a hospital providing inpatient diagnostic and therapeutic care
to persons with mental disorders.
4.6.31
Rehabilitation Services
A. If a hospital provides rehabilitation,
physical therapy, occupational therapy, audiology or speech pathology services,
such services shall have a defined organizational structure with established
lines of authority and responsibility that ensures accountability in patient
care and administrative matters. Such services shall be integrated with other
departments and services of the hospital.
B. The director(s) of the service or services
(may be single discipline departments or multi- discipline departments) shall
be qualified by training, experience, and capability to properly supervise and
administer the services. The director retains responsibility for the personnel
providing the service.
C. Services
shall be provided by staff who meet the qualifications specified by the medical
staff and hold current licensure, certification or registration as may be
required by law (see R.I. Gen. Laws Chapters 5-40, 5-40.1, and 5-48
).
D. The director of the
service(s) shall ensure there are a sufficient number of qualified staff to:
1. evaluate each patient requiring
services;
2. initiate a plan of
treatment;
3. provide treatment
services;
4. instruct and supervise
support staff when they are used to render services.
E. Services shall be provided in accordance
with written orders by persons who are authorized by the medical staff to order
such services. Orders shall be incorporated into the patient's clinical
record.
F. Services shall be
furnished in accordance with a written plan of treatment, which is established
by the practitioner ordering the service in collaboration with an individual
qualified to provide the service.
1.
Treatment plans shall include treatment goals, as well as type, amount,
frequency and duration of services.
2. Treatment plans shall be revised as
necessary. Changes in the treatment plan shall be documented in writing and
supported by clinical record information such as evaluations, test results, or
orders.
G. Treatment
shall be documented in the clinical record by the responsible person at the
time services are provided. Progress notes (to note the patient's status in
relationship to goal attainment) shall be recorded periodically in accordance
with hospital policy.
H. In
addition to the above, the requirements of §4.6.29 of this Part and all
applicable sections of these regulations shall apply to inpatient
rehabilitation units.
4.6.32
Substance Abuse Treatment
Services/Programs
A. Hospitals with
substance abuse treatment programs shall have such program(s) under the
direction of a physician who has experience and training in the treatment of
individuals with chemical dependency.
B. Each program shall have a clinical
supervisor to oversee counseling activities directly and provide clinical
supervision. The clinical supervisor shall have a minimum of a master's degree
in a clinically related field, and a minimum of three (3) years supervisory
experience; be licensed as a chemical dependency clinical supervisor by the
Rhode Island Board for Licensing of Chemical Dependency Professionals; or be a
licensed chemical dependency professional and, at a minimum, have taken a state
Department of Behavioral Healthcare, Developmental Disabilities and Hospitals
(BHDDH) approved course in clinical supervision.
C. The substance abuse program shall be
staffed with a sufficient number of specially qualified professional and
ancillary personnel who shall be assigned duties and responsibilities
consistent with their education and experience.
D. There shall be sufficient number of staff
to carry out the treatment program, that includes no less than:
1. initial evaluation, including medical and
psychosocial assessment; and
2. the
establishment and implementation of written treatment plans.
E. Medical records shall include:
1. Medical assessment including medical
history and history of drugs prescribed;
2. History of alcohol and/or other drug use,
including age of onset, duration, patterns, and consequences or resultant
effects (to include medical, physical, psychosocial, employment, educational,
legal, financial, family, social, recreational and other pertinent
areas);
3. Special exams, tests, or
evaluations necessary for complete initial and on-going assessment;
4. Individualized treatment plan, including
problem list, short- and long- term goals expressed in measurable behaviors,
treatment interventions, and timeframes;
5. Documentation of all treatment provided,
at the time of provision;
6. At
least weekly progress notes, describing progress, or lack thereof, toward goal
achievement;
7. Discharge summary
and aftercare plan; and
8.
Post-discharge follow-up contacts.
F. Hospitals with substance abuse treatment
programs shall maintain identifiable patient information in confidence in
accordance with all applicable state and federal statutes and regulations,
including, but not limited to, 42 C.F.R. Part
2 (2017).
G. In addition to the above, the requirements
of §4.6.29 of this Part and all applicable regulations contained in these
regulations shall apply to the substance abuse treatment program.
4.6.33
Caregiver Services
A. Any hospital licensed pursuant to
§
4.4 of
this Part, shall provide each patient or, if applicable, the patient's legal
guardian with an opportunity to designate at least one caregiver under R.I.
Gen. Laws Chapter 23-17 following the patient's entry to the hospital.
1. Unconscious or Incapacitated Patient
In the event that the patient is unconscious or otherwise
incapacitated upon entry into the hospital, the hospital shall adhere to the
following requirements:
a. Provide the
patient or the patient's legal guardian with an opportunity to designate a
caregiver within a given timeframe, at the discretion of the attending
physician, following the patient's recovery of consciousness or capacity;
and
b. Notify the patient that the
purpose of providing a caregiver's identity is to include that caregiver in
discharge planning and sharing of post-discharge care information or
instruction.
2. Patient
Designates Caregiver
In the event that the patient or the patient's legal
guardian designates an individual as a caregiver pursuant to R.I. Gen. Laws
Chapter 23-17, the hospital shall adhere to the following requirements:
a. Record the patient's designation of the
caregiver in the patient's medical record along with the caregivers;
relationship to the patient, name, telephone number and address;
b. Promptly request the written consent of
the patient, or the patient's legal guardian, to release medical information to
the patients designated caregiver following the hospitals established
procedures for releasing personal health information and in compliance with all
federal and state laws;
c. If the
patient or the patient's legal guardian declines to consent to release medical
information to the patients designated caregiver, the hospital is not required
to:
(1) Provide notice to the caregiver in
accordance with R.I. Gen. Laws §
23-17.27-4 and §4.6.33(C) of this Part; or
(2) Provide information contained in the
patients discharge plan in accordance with R.I. Gen. Laws §
23-17.27-5 and §4.6.33(E) of this Part.
3. Patient Declines to Designate Caregiver
In the event that the patient, or the patient's legal
guardian, declines to designate a caregiver, the hospital shall promptly
document this in the patient's medical record.
4. Patient Elects to Change Caregiver
A patient, or a patient's legal guardian, may elect to
change the patient's caregiver at any time, and the hospital must record this
change in the patient's medical record before the patient's discharge.
5. The designation of a caregiver
by a patient, or a patient's legal guardian, in accordance with §4.6.33(A)
of this Part does not obligate any individual to perform any after-care tasks
for any patient.
6. The
requirements set forth in §4.6.33(A) of this Part shall not be construed
to require a patient, or a patient's legal guardian, to designate any
individual as a caregiver as defined by R.I. Gen. Laws Chapter 23-17.27 and
these Regulations.
B.
Notice of Patient Discharge to Designated Caregiver
Any hospital licensed pursuant to §
4.4 of this Part shall notify
the patient's designated caregiver of the patient's discharge or transfer to
another facility licensed by the State of Rhode Island as soon as possible, in
any event, upon issuance of a discharge order by the patient's attending
physician or other health care professional.
1. In the event that the hospital is unable
to contact the designated caregiver, the lack of contact shall not interfere
with, delay or otherwise affect the medical care provided to the patient or an
appropriate discharge of the patient. The hospital shall promptly document the
attempt to contact the patient's designated caregiver in the patient's medical
record.
C. Instruction to
Designated Caregiver
As soon as possible and prior to a patient's discharge from
a hospital, the hospital shall consult with the designated caregiver and the
patient regarding the caregiver's capabilities and limitations. The hospital
will then issue a discharge plan that describes the patient's after-care needs
at his or her residence in accordance with the provisions set forth in
§§4.6.33(C)(1) through (4) of this Part.
1. Caregiver Consultation Session and
Assessment
The consultation session will include an assessment of the
caregiver's capability to provide after care and any limitations the caregiver
foresees in providing after care. The hospital shall adhere to the following
requirements regarding the consultation and assessment:
a. At its discretion, determine which
hospital staff are best qualified to conduct the caregiver assessment;
and
b. If, upon assessment, the
hospital determines a caregiver may have difficulty supplying the needed care
safely, the discharge plan may be adjusted accordingly and alternate care
arrangements may be made in consultation with the caregiver.
2. Discharge Plan Schedule
The consultation and the issuance of a discharge plan shall
occur on a schedule that takes into consideration the following:
a. The severity of the patient's condition;
b. The setting in which care is to
be delivered; and
c. The urgency of
the need for caregiver services.
3. Unable to Contact Caregiver
In the event that the hospital is unable to contact the
designated caregiver, the lack of contact shall not interfere with, delay, or
otherwise affect the medical care provided to the patient, or an appropriate
discharge of the patient. The hospital shall promptly document the attempt in
the patient's medical record.
4. Discharge Plan Content
At minimum, a discharge plan shall include:
a. The name and contact information of the
caregiver designated in accordance with §4.6.33(A) of this Part;
b. A description of all after-care tasks
recommended by the patient's physician or other health care professional,
taking into account the capabilities and limitations of the
caregiver;
c. Contact information
for any health care, community resources, and long-term services and support
necessary to successfully carry out the patients discharge plan.
D. Caregiver Training
The hospital issuing the discharge plan must offer to
provide caregivers with instruction in all after-care tasks described in the
discharge plan. Any training or instructions provided to a caregiver shall be
provided, to the extent possible, in non-technical language and in the
caregiver's native language.
1. At
minimum, any training or instructions provided to a caregiver shall include the
following:
a. A live or recorded
demonstration of the tasks performed by the hospital employee or individual
with whom the hospital has a contractual relationship authorized to perform the
after-care task; and
b. An
opportunity for the caregiver and patient to ask questions about the after-care
tasks; and
c. Answers to the
caregiver's and the patient's questions provided in a culturally competent
manner and in accordance with the hospitals requirements to provide language
access services under state and federal law.
2. Any instruction required under
§4.6.33(C) of this Part shall be documented in the patient's medical
record, including the date, time and contents of the
instruction.
E.
Non-Interference with Powers of Existing Health Care Directives
1. Nothing in R.I. Gen. Laws Chapter 23-17.27
or these regulations shall be construed to interfere with the rights of an
agent operating under a valid directive pursuant to R.I. Gen. Laws Chapter
23-4.10 (Health Care Power of Attorney) or R.I. Gen. Laws §
23-4.11-3.1 (Medical Orders for Life Sustaining Treatment).
2. A patient may designate a caregiver in an
advance directive.
F.
Nothing in R.I. Gen. Laws Chapter 23-17.27 or these regulations shall delay the
discharge of a patient, or the transfer of a patient from a hospital to another
facility.
G. Caregiver
Reimbursement
1. A caregiver shall not be
reimbursed by any government or commercial payer for after-care assistance that
is provided pursuant to R.I. Gen. Laws Chapter 23-17.27 or these regulations,
with the sole exception that R.I. Gen. Laws Chapter 23-17.27 shall not
supersede the applicability of wage replacement benefits paid to workers under
Rhode Island's temporary disability insurance program, pursuant to R.I. Gen.
Laws §
28-41-35.
2. Nothing in to R.I. Gen. Laws Chapter
23-17.27 or these regulations shall be construed to impact, impede or otherwise
disrupt or reduce the reimbursement obligations of an insurance company, health
service corporation, hospital service corporation, medical service corporation,
health maintenance organization, or any other entity issuing health benefits
plans.