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TITLE 11
DEPARTMENT OF HEALTH
CHAPTER 95
FREESTANDING SURGICAL OUTPATIENT FACILITIES
Purpose
Definitions
Licensing
Licensing revocation
Administration
Anesthesia
Arrangement for services
Communication
Construction
Dietetic service
Disaster planning
Engineering and maintenance
Governing body
Infection control
Inservice education
Laboratory
Laundry service
Life safety
Medical director
Medical records
Medical staff
Nuclear medical service
Nursing service
Pathology
Patients' 	rights and patients' 	care
Penalty
Pharmaceutical service
Radiology service
Socal work service
Surgical facilties
Transfer agreement
Severability
§11-95-1 	Purpose. 	The purpose of this chapter is to esta-
blish minimum requirements for the protection of the health,
welfare, 	and safety of patients, 	personnel, 	and the public in
freestanding surgical outpatient facilities. 	This chapter shall
not be construed as lowering standards, 	ordinances, 	or rules
established by other agencies of government. 	In all instances
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§11-95-1
the more stringent rules shall apply. 	[Eff MAR O3 1986 	]
(Auth: HRS §§321-9, 	321-10, 	321-11) 	(Imp: HRS §§321-10, 	321-11)
§11-95-2 	Definitions as used in this chapter:
"Administrator" is the person to whom is delegated the
responsibility for the interpretation and implementation of the
policies and programs established by the governing body. 	This
person may or may not be the same as the medical director. 	The
administrator shall have had suitable and sufficient previous
experience in administration of a medical facility.
"Anesthesia assistant" means a person who has successfully
completed a four year educational program for physicians' 	assis-
tants that includes two years of specialized academic and clinical
training in anesthesia.
"Anesthesiologist" means a physician whose specialized train-
ing and experience qualify the physician to administer anesthetic
agents and to monitor the patient under the influence of these
agents.
"Anesthetist" means a certified registered nurse anesthetist.
"Broad service hospital" means a medical facility which
is staffed and equipped to provide inpatient medical and surgical
care for acute illness, 	injury, 	and obstetrics over a period
of time longer than twenty-four hours.
"Cardiopulmonary resuscitation" or "CPR" means an emergency
first aid procedure that consists of opening and maintaining
a patient's airway, 	providing artificial ventilation by means
of rescue breathing, and providing artificial circulation by
means of ~ ternal cardiac compression.
"Chest x-ray" means a full-sized 11" x 14" film taken by
the standard technique.
"Dentist" means any person having a valid, 	unrevoked, 	license
issued by the State of Hawaii to practice "dentistry" as defined
by chapter 448, HRS.
"Department" means the department of health of the State
of Hawaii.
"Dietitian" means a person who:
(1) 	Is registered by the American Dietetic Association;
or
(2) 	Is eligible for examination to become a registered
dietitian.
"Director" means the director of health of the State of
Hawaii.
"Freestanding surgical outpatient facility" 	is a facility
developed for the purpose, of performing surgical procedures which
do not require hospitalization. 	The procedures are referred
to as permitted procedures. 	Patients admitted to the facility
shall remain only long enough to satisfy the objective of the
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facility and in no case shall they remain longer than eighteen
hours. 	The facility 	shall provide for continuous physician's
services and for continuous registered professional nursing ser-
vices, 	on the premises, whenever a patient is in the facility.
It shall have an organized administrative structure. 	The facility
shall not be an integral part of a broad service hospital and
shall not include the offices of private physicians, 	dentists,
or podiatrists. 	If the facility is located in the same building
with a broad service hospital or with physician's offices, 	the
freestanding surgical outpatient facility shall be a "distinct
part", 	separate from the other medical facilities. 	A "distinct
part" shall be an entire, 	physically identifiable unit with its
own staff, 	own records, and own equipment. 	There shall not be
any question as to the distinctness of the freestanding surgical
outpatient facility from the other medical facilities and services
in the same building.
"Governing body" means the individual, 	individual agency,
group, 	or corporation which has the ultimate responsibility and
authority for the conduct of the freestanding surgical outpatient
facility and is named in the license as the governing body.
"Licensee" means the governing body to whom the license
is issued.
"Licensed practical nurse" means a nurse licensed as such
by the State of Hawaii, 	as defined by chapter 457, 	HRS.
"Local hospital" means a l.'censed hospital on the same island
as the freestanding surgical outpatient facility.
"Medical director" is the physician who is responsible for
planning, 	organizing, conducting and directing the medical affairs
of the facility. 	The medical director shall currently hola,active
surgical or anesthesiologist privileges at a local hospital.
"Medical staff" are physicians and dentists authorized by
the governing body to practice their profession within the
facility.
"Operating room" 	is a room specifically set aside in which
surgical procedures only are performed.
"Outpatient" is a person seeking treatment from the free-
standing surgical outpatient facility and who does not stay over-
night in the facility.
"Pathologist" means a physician certified or eligible to
be certified by the American Board of Pathology.
"Patient" means a person admitted to and receiving care
in a freestanding surgical outpatient facility.
"Permitted procedures" are those which:
(1) 	Are commonly performed on an inpatient basis in
hospitals but may be safely performed in a freestanding
surgical outpatient facility;
(2) 	Are not of a type that are commonly or safely performed
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in physicians' 	offices.
(3) 	Are limited to those requiring a dedicated operating
room, 	or suite, and generally requiring a post-operative
recovery room or short term convalescent room;
(4) 	Do not generally result in extensive blood loss;
(5) 	Do not generally require major or prolonged invasion
of body cavities;
(6) 	Do not generally involve major blood vessels;
(7) 	Are not generally of an emergency or life threatening
nature;
(8) 	Do not include procedures where the surgical operating
time plus the post-anesthetic recovery time would
normally exceed the planned business hours of the
facility.
nPharmacistn means a nregistered pharmacist" as defined
by chapter 461, 	HRS.
"Physician" means a person having in the State of Hawaii
a valid license to practice medicine pursuant to chapters 453
or 460, 	HRS.
"Post-anesthetic recovery time" means that period of time
which ends when:
(1) 	The patient is alert and oriented and has reached pre-
operative mental status; 	and
(2) 	The patient's vital signs have returned to be within
normal physiological limits; 	and
(3) 	The patient is able to ambulate without dizziness and
has regained pre-operative ambulation ability; and
(4) 	The patient is not nauseated or vomiting and can retain
fluids by mouth.
"Recovery area" refers to a specific room or space used
for post-anesthetic recovery of surgical patients.
"Registered professional nurse" means a person who is
licensed as a "registered nurse" in the State of Hawaii, 	as
defined by chapter 457, 	HRS.
"Tuberculin test" means an intradermal injection of
.0001 mg (5 tuberculin units) 	of purified protein derivative
in 0.1 cc of sterile diluent. 	If the size of any resulting
palpable induration at forty-eight hours and seventy-two hours
after injection is equal to or greater than 10 mm in its trans-
verse diameter, 	the reaction to the skin test shall be considered
positive. 	[Eff 	] 	(Auth: 	HRS §§321-9, 	321-10)
(Imp: HRS §§26-13, 	321-1, 321-10)
§11-95-3 	Licensing. 	(a) No person, 	or group of persons,
shall operate a freestanding surgical outpatient facility unless
it is licensed by the director.
(b) 	Any person, 	or group of persons desiring to operate
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§11-95-4
a freestanding surgical outpatient facility shall apply to the
director for a license on forms provided by the department.
The director shall issue a license if the proposed facility meets
the requirements of this chapter.
(c) 	A license, 	unless abandoned or revoked for 	just cause,
shall be renewed every two years, 	on date of issue, 	or of such
other interval of time as may be decided by the director. 	Appli-
cation for renewal of license shall be made by governing body
of the freestanding surgical outpatient facility sixty days prior
to expiration date as determined from the license. 	If application
for renewal is not filed, 	the license shall be cancelled automa-
tically as of the expiration date determined from the license.
After receiving notice of deficiencies following an inspection,
the facility shall file a plan of correction with the department
within ten days. 	Deficiencies shall be corrected within a reason-
able time; 	failure to do so may result in failure to renew the
license.
(d) 	A provisional license may be issued for a specified
period of time at the discretion of the director, 	should addi-
tional time for correction of deficiencies be deemed advisable.
Not more than two successive provisional licenses shall be issued
to a particular facility.
(e) 	With respect to a particular facility, 	a specific rule
may be waived for a period of one year at the discretion of the
director.
(f) 	Each license shall be issued to a physical facility
and to a governing body. 	A change in either requires that the
department be notified. 	A new license, 	at the discretion of
the director, may be required.
(g) 	The department shall be notified within fifteen days
if a new administrator or a new medical diretor is appointed.
A change of administrators or medical directors, 	at the discretion
of the director, 	may require that a new license be issued.
(h) 	The license issued by the director shall be posted
in a conspicuous place visible to the public on the premises
of the freestanding outpatient surgical facility.
(i) 	Appropriate fees, 	if any, 	as determined by the director,
shall be charged by the department for obtaining a new license
or obtaining a license renewal. 	Prior notice of the amount of
the fee shall be provided the licensee.
(j) 	Inspection visits may be made to a licensed freestanding
surgical outpatient facility at any reasonable time without prior
notice by authorized staff of the department.
[Eff 	t1.4R O3 198& 	] 	(Auth: HRS §§321-9, 321-10, 	321-11)
(Imp: HRS §§,91-14, 	91-15, 	321-1, 321-10, 321-11)
§11-95-4 	License revocation. 	(a) The director, 	after due
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notice, 	and after suitable opportunity for a hearing, may suspend,
revoke, 	or refuse to issue or renew a license to any governing
body because of failure to meet:
(1) 	The requirements of this chapter; 	or
(2) 	The conditions under which the license was issued.
(b) 	Any governing body affected by the director's decision
for denial, 	suspension, 	or revocation may appeal in accordance
with chapter 91, HRS.
(c) 	When a license has been revoked, 	or when a license
has not been renewed, 	an application for a new license shall
not be accepted until a period of one year has passed from the
time of the revocation or refusal to renew.
[Eff 	] (Auth: HRS §§321-9, 	321-10, 	321-11)
(Imp: 	HRS §§321-10, 	321-11)
§11-95-5 	Administration. 	(a) The administrative personnel
under the direction of an administration shall develop and carry
out such administrative procedures as are necessary to achieve
the objectives and policies of the governing body.
(b) 	The administrator shall establish policies and develop
procedures to ensure that all employees are free of infectious
diseases. 	These policies shall include:
(1) 	Pre-employment and an annual health evaluation specifi~
cally oriented to rule out infectious diseases shall
be conducted by a licensed physician;
(2) 	A tuberculin skin test shall be done. 	If the tuberculin
skin test is significant, a standard chest x-ray and
appropriate medical follow-up shall be obtained. 	A
yearly chest x-ray thereafter shall be required for
three successive years;
(3) 	If the tuberculin skin test is negative, 	a second
tuberculin skin test shall be done after one week,
but not later than three weeks after the first 	test.
The result of the second test shall be considered the
baseline.and used to determine apropriate follow-up.
If the second test is negative, 	it shall be
repeated once yearly thereafter until it becomes
significant;
(4) 	Any employee who develops evidence of an infectious
disease shall be immediately excluded from any duties
relating to food handling and direct patient contact
and shall remain excluded until such time as a physician
certifies that it is safe for this individual to resume
his or her duties. 	Skin lesions, 	respiratory tract
symptoms and diarrhea shall be considered presumptive,
evidence of infectious disease;
(5) 	There shall be adequate documentation that all employees
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have been fully informed about, 	and understand, 	para-
graphs (1) and (2).
(c) 	The administrator, with the active participation of
the medical and nursing staff, 	shall establish policies providing
for evaluation of the quality of care provided in the facility.
These policies shall provide for identification of problems,
analysis or problems to determine cause and documentation of
remedial action taken.
(d) 	The administrator shall ensure that the facility 	shall
not deny admission to any individual solely on account of race,
religion, 	color, 	ancestry, 	or national origin.
[Eff 	MAR 	1986 	] 	(Auth: HRS §§321-9, 	321-10, 	321-11)
(Imp: HRS §321-10)
§11-95-6 	Anesthesia. 	(a) General, 	local, 	or regional
anesthesia shall be administered to patients only by a certified
registered nurse anesthetist or by a qualified physician. 	The
anesthesia shall be administered only under the supervision of
a licensed physician.
(b) 	Flammable anesthetics shall be prohibited except when
construction, 	storage and equipment meet the standards of the
National Fire Protection Association Bulletin No. 	56G "Standards
for the Use of Inhalation Anesthetics in Ambulatory Care Facili-
ties" 1980.
(c) 	A person with training and experience in cardiopulmonary
resuscitation shall be on the premises of the facility until
all patients have been discharged. 	[Eff 	MAR 	]
(Auth: HRS §§321-9, 	321-10) 	(Imp: HRS §321-10) 	•
§11-95-7 	Arrangement for services. 	Where the facility
does not employ a qualified person to render a required and neces-
sary service, 	it shall have a written contract with an appro-
priately qualified outside person or provider to perform such
service. 	[Eff 	] (Auth: HRS §§321-9, 321-10) 	(Imp:
HRS §321-10)
§11-95-8 	Communication. 	(a) Arrangements shall be made
to quickly summon additional personnel to any area when needed
in an emergency situation.
(b) 	There shall be sufficient telephones (not pay tele-
phones) 	located in separate areas so that at least one is quickly
accessible in any part of the facility for emergency use.
[Eff 	] (Auth: HRS §321-9, 	321-10)
(Imp: HRS §321-10)
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§11-95-9
§11-95-9 	Construction requirements. 	(a) The facility shall
be constructed and maintained in accordance with state and county
zoning, 	building, 	fire safety, 	and sanitation laws, 	ordinances,
and rules. 	New construction and remodeling shall be guided by
"Minimum Requirements of Construction & Equipment for Hospital
& Medical Facilities" DHEW Publication No. 	(HRA) 	79-14500 as
it existed on December 31, 	1984.
(b) 	The facility shall be accessible to and functional
for 	physically handicapped persons.
(c) 	There shall be adequate space to allow free movement
of occupants using wheelchairs, walkers, 	canes and crutches to
and from exits, 	post-operative recovery areas, 	bathrooms, 	closets,
dressing areas, 	and common hall areas.
(d) 	Provision shall be made for each patient to have use
of a lockable closet, 	dressing cubicle, 	or dressing room.
(e) 	A waiting room of appropriate size shall be provided
and toilet rooms, 	separate from patient toilets, 	shall be easily
accessible to those in the waiting area.
(f) 	Suitable dressing areas and toilet facilities for staff
use, 	separate from patient use, 	shall be provided.
(g) 	One or more examining rooms separate from recovery
and operating rooms shall be provided.
(h) 	Grab bars shall be provided in patient and waiting
room toilets. 	Each bathroom shall provide at least one washbasin
and one commode~
(i) 	Operating and recovery rooms shall be located so as
to prevent through traffic except in the case of emergency.
Entrance,,and exits to these rooms shall be by means of interior
doors except for emergency outdoor exit doors which may be
provided as needed.
(j) 	There shall be adequate scrub-up facilities and work
areas for the preparation, 	sterilization, and storage of instru-
ments and supplies.
(k) 	Each patient toilet and bathroom facility 	shall have
a suitable nurses' 	call system for signalling the need for assis-
tance.
(1) 	Adequate supply of hot and cold potable running water
must be supplied at all times. 	Temperature of hot water at plumb-
ing fixtures used by patients shall be.automatically regulated
and shall not exceed 110°F.
(m) 	Bedpans and urinals shall be available for use as well
as suitable methods and equipment for cleaning and sterilizing
same. (n) 	In the event that a sexually mixed recovery room is
utilized, 	suitable screens or curtains shall be provided to ensure
privacy for each patient.
(o) 	Patient beds, wherever located, 	shall be surrounded
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§11-95-9
by at least three feet of clear floor area.
(p) 	All rooms in which patient care is carried out shall
be on or above grade level.
(q) 	Floors and walls.
(1) 	Floors shall be of slip resistant material, 	flush at
doorways.
(2) 	Floors shall be of material which does not retain odors.
(3) 	Scatter rugs shall not be used.
(4) 	Walls, 	floors, 	ceilings and decorative items in rooms
shall be made of material which permit washing, 	clean-
ing, 	and painting.
(r) 	Where appropriate, 	screening of doors and windows shall
be provided using screening having sixteen meshes per inch.
(s) 	Neither sliding doors nor folding doors shall be used
as room or building exit doors. 	All double-acting doors shall
be provided with vision panels.
(t) 	The minimum clear width of corridors shall be
forty-four inches, 	except when a general anesthetic is used in
the facility. 	In the latter case, 	corridors which serve non-
ambulatory patients shall be a minimum of eight feet wide.
(u) 	Suitable locked storage space shall be available for
storing of maintenance equipment and supplies.
(v) 	The water supply shall comply with chapter 340E, HRS.
(w) 	Ventilation shall comply with chapter 11~39, 	relating
to air conditioning and ventilating.
(x) 	Additions, 	alterations, 	and all repairs to existing
buildings.
(1) 	Where the structure was in use for this type of occu-
pancy prior to the effective date of this chapte~,
the director may waive or modify any portion of these
construction standards, 	provided the exceptions do
not create a hazard to patients, 	personnel or public.
In no case shall any fire safety standards, 	as deter-
mined by the county fire marshal, 	be waived or modified;
(2) 	Drawings and specifications for all new construction
or additions, 	alterations, 	or repairs to existing build-
ings subject to the provisions of this chapter shall
be submitted to the licensing branch of the department
for review, 	and a certificate of need where applicable,
shall also be submitted;
(3) 	Construction shall not commence prior to the depart-
ment's approval of construction drawings. 	Specifica-
tions shall comply with this chapter, 	the county fire
marshal's rules, 	and with county building codes and
ordinances;
(4) 	The department shall review each submittal and advise
the applicant, 	in writing, 	of its findings, 	within
a reasonable time, 	with respect to approval, 	dis-
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§11-95-9
approval, 	or any mandatory changes required;
(5) 	Unless construction is commenced within one year of
the approval of final construction drawings and
specifications, 	the latter with the previously approved
application, 	shall be resubmitted for review and
reapproval;
(6) 	Minor alterations which do not affect structural
integrity or fire safety and do not change functional
operation and do not increase beds or services over
that for which the facility is licensed, 	may be sub-
mitted either by freehand drawings or by the more
conventional drawings and specifications.
(y) 	There shall be appropriately equipped utility rooms,
at least one clean and one soiled for each operating suite.
[Eff 	t1AR 0 3 1986 	] 	(Auth: HRS §§321-9, 	321-10) 	(Imp: HRS
§§46-4~ 	62-34, 64-91, 	65-71, 	66-71, 70-71, 132-3, 321-10,
34OE-l to 34OE-9)
§11-,95-10 	Dietetic service. 	A consultive dietitian shall
supervise the preparation and service of whatever special diets
may be deemed necessary for the patients to meet the objectives
of the facility. 	There shall be written policies covering
whatever dietetic services are deemed necessary by the governing
body. 	[Eff 	0 	] 	(Auth: HRS §§321-9, 	321-10)
(Imp: HRS §321-10)
§11-95-11 	Disaster planning~ 	Appropriate policies shall
be written to provide for cooperation with civil and military
authorities in the event of a disaster for disaster relief under
chaper 127, HRS which would require use of the equipment and
personnel of the facility staff.
[Eff 	MJ)R 	] 	(Auth: HRS §§321-9, 321-10)
(Imp: 	HRS §321-10)
§11-95-12 	Engineering and maintenance. 	(a) The facility
shall have an appropriate written preventive maintenance program
which documents compliance with all life safety codes of the
state and county.
(b) 	Inspection of all devices essential to the health and
safety of patients, 	personnel, 	and visitors shall be carried
out at sufficiently frequent intervals to ensure operational
performance.
(c) 	Maintenance and routine repairs to the facility shall
not require reviews or approval by the department.
(d) 	Appropriate facilities for routine building cleaning
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§11-95-14
shall be provided. 	[Eff 	] 	(Auth: HRS §§321-9,
321-10) 	(Imp: HRS §§321-10, 342-17)
§11-95-13 	Governing body. 	(a) The governing body shall
be the supreme authority of the facility, 	responsible for the
management, 	control and operation of the facility, 	including
the appointment of an administrator and the appointment of a
medical director.
(b) 	The governing body shall appoint the medical staff
and delineate surgical privileges for each physician and dentist.
(c) 	The governing body shall specify.which of the permitted
procedures may be done in the facility.
(d) 	The governing body shall specify which procedures may
be done in specific areas of the facility.
(e) 	The governing body shall be formally organized in accor-
dance with a written constitution and by-laws.
(f) 	The governing body shall meet regularly, 	at least once
a year, 	and the minutes of these meetings shall be kept as a
permanent record in the facility. 	[Eff 	MAR 	]
(Auth: HRS §§321-9, 	321-10) 	(Imp: HRS. §321-10)
§11-95-14 	Infection control. 	(a) Definitive policies and
procedures governing sterilization techniques shall be developed.
All equipment shall be sterilized either by pressurized steam
sterilization or gas sterilization. 	The procedures shall be
written and shall include:
(1) 	The technique to be used for a particular instrurr~nt
or group of instruments;
(2) 	The length of time to accomplish sterilization;
(3) 	Termperature, 	time and pressure control levels esta-
blished for steam sterilization;
(4) 	Proper methods of preparation of items for steriliza-
tion;
(5) 	Shelf storage time for sterile items established;
(6) 	Use of sterilizer indicators;
(7) 	Use of routine (at least monthly) 	bacteriological steri-
lizer culture controls.
(b) 	Written procedures shall also be developed to provide
for: (1) 	Prohibition of re-use of disposable, 	one-time use items;
and
(2) 	Biologically safe methods of disposal of contaminated
items such as needles, 	syringes, 	catheters, 	gloves,
pathological wastes, 	contaminated dressings, 	and any
other contaminated items which might be present in
the facility.
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§11-95-14
(c) 	There shall be an infection control committee esta-
blished to investigate any patient infection and to take prompt
and appropriate remedial action to prevent a recurrence. 	This
committee shall consist of a physician and a registered nurse,
in addition to others. 	The facility, shall:
(1) 	Maintain permanent written reports of all results of
investigations of infections and the remedial action
taken;
(2) 	Report promptly to the licensing branch of the depart-
ment any infectious diseases which they discover that
may present a potential hazard to patients, 	personnel
and the public. 	Included, 	but not limited to, 	are
the reportable diseases and the occurrence of other
diseases in outbreak form; 	and
(3) 	Provide for adequate patient post-discharge follow-
up in order to discover any patient infection and to
record same, in the files of the infection control
committee.
(d) 	There shall be a continuous education program provided
to all facility personnel on the cause, 	transmission, 	prevention,
and elimination of infections.
(e) 	A policy shall be established for strict control of
visitors to prevent their casual access to treatment and post-
operative recovery areas. 	[Eff 	]
(Auth: HRS §§321-9, 	321-10) 	(Imp: 	HRS §321-10)
§11-95-15 	Inservice education. 	There shall be an appro-
priate tnservice education program. 	This shall include, 	but
not be limited to, 	annual training in fire prevention, 	infection
control, and accident prevention. 	There shall be adequate docu-
mentation of these educational procedures.
[Eff 	0 3 1986 	] 	(Auth: 	HRS §§321-9, 321-10)
(Imp: 	§321-10)
§11-95-16 	Laboratory. 	Sufficient laboratory facilities
shall be made available to carry out the objectives of the
facility. 	The laboratory procedures shall be carried out by
qualified medical technologists, 	at least one of whom shall be
available as long as a patient is in the facility. 	Such a labora-
tory shall be under the supervision of an appropriately qualified
physician. 	[Eff 	!986 	]
(Auth: HRS §§321-9, 	321-10) 	(Imp: 	HRS §321-10)
§11-95-17 	Laundry service. 	(a) Provision shall be made
for 	the handling, 	storage, 	and transportation of soiled and clean
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§11-95-20
laundry and for satisfactory cleaning procedures.
(b) 	Infectious laundry shall be handled in accordance with
section 325-7, HRS, 	relating to potentially infectious laundry.
[Eff 	MAR O3 1986 	] 	(Auth: HRS §§321-9, 	321-10)
(Imp: 	HRS §§321-10, 	321-11)
§11-95-18 	Life safety. 	(a) Facilities licensed under this
chapter shal.1 be inspected at least annually by appropriate fire
authorities for compliance with state and county laws.
(b) 	A written and posted fire control and evacuation plan
shall be maintained and kept current. 	[Eff 	MAR 0 3 1986 	]
(Auth: HRS §§321-9, 	321-10) 	(Imp: HRS §§132-8, 	321-10)
§11-95-19 	Medical director. 	(a) 	It shall be the responsi-
bility of the medical director to develop appropriate written
policies and procedures to provide the necessary preventive,
diagnostic, 	and therapeutic services to patients in order to
achieve the objectives of the facility.
(b) 	In cooperation with the administrator, 	the medical
director shall:
(1) 	Develop appropriate staff professional educational
programs; 	and
(2) 	Recommend to the governing body the names of physicians
and dentists to be appointed to the medical staff.
(c) 	The medical director shaLl monitor and supervise all
medical and nursing procedures carried out in the facility,
especially including all infection control procedures and 	~
policies. 	[Eff 	MAR 0 3 1986 	] 	(Auth: HRS §§321-9, 	321-10)
(Imp: HRS §321-10)
§11-95-20 	Medical records. 	(a) There shall be available
sufficient, appropriate qualified staff and necessary supporting
personnel to facilitate the accurate processing, 	checking,
indexing, 	filing, 	and prompt retrieval of records and record
data.
(b) 	All patient records shall be considered conftdential
and the property of the facility which shall secure them against
loss, 	destruction, 	defacement, 	tampering, 	or use by unauthorized
persons.
(c) 	Patient records shall contain, 	but not necessarily
be limited to, 	the following information:
(1) 	Prior to surgery, 	the patient record shall contain
the following:
(A) 	Sufficient history, 	physical exa~ination, 	x-ray
and laboratory data to support the admitting
95-13
8 2 ~

§11-95-20
diagnosis and the decision to carry out the pro-
posed procedure;
(B) 	Sufficient history, 	physical examination, 	and
laboratory data to support the decision as to
which anesthetic techniques and medications are
to be used during the procedure;
(C) 	Results of all pertinent consultation reports,
laboratory and x-ray reports shall be recorded
on the chart by the patient's physician. 	Originals
or photocopies of the originals shall be on the
chart within forty-eight hours of admission to
the facility;
(D) 	Documentation that sufficient attention has been
given to:
(i) 	Preventing and preparing for 	the customary
complications .of the proposed surgical proce-
dure and the proposed anesthetic procedure;
(ii) 	Preventing and preparing for any special
hazards confronting a particular patient;
(E) 	An informed consent form shall be signed by the
patient or the patient's guardian, 	or patient's
parents, 	and be filed in the chart;
(2) 	Within forty-eight hours following surgery, 	the
patient's record shall contain:
(A) 	An operative note which shall clearly indicate
what was found and what was done;
(B) 	An anesthetic note which shall specify the anesthe-
tic techniques and medications used, 	as well as
• 	dosages of the medications. 	It shall also contain
the result of appropriate physiological monitoring
during the anesthetic induction, maintenance and
recovery period. 	A record of any untoward develop-
ment during this period shall also be noted;
(C) 	All medications given to or taken by the patient
shall be properly recorded in - respect to time
given, 	dose, 	and any response noted;
(3) 	A discharge note including the final diagnosis at the
time of discharge;
(4) 	A copy of the discharge document required in
•section ll-95-25(d).
(d) 	A daily log with monthly summaries of all procedures
performed and the disposition of all patients shall be kept by
the facility. 	[Eff 	MAR o 3 1986 	] 	(Auth: HRS §§321-9,
321-10) 	(Imp: HRS §321-10)
§11-95-21 	Medical staff. 	(a) There shall be an organized
medical staff that has overall responsibility for the quality
95-14

)
§11-95-23
of medical care provided to the patients and for the ethical
conduct and professional practice of its members.
(b) 	The facility shall not permit interns, 	residents,
fellows, 	graduates of foreign medical schools, 	or medical students
in an apropriate training program to perform a service for which
a license is required by the State of Hawaii unless they are
at that time licensed by the State of Hawaii as a physician,
or else under the direct control and direct supervision of a
licensed physician.
(c) 	Each member of the medical staff shall have the same
surgical privileges at a local licensed hospital as the member
seeks at the freestanding surgical outpatient facility. 	Main-
tenance of those surgical privileges shall be certified biennially
by a local licensed hospital. 	[ Eff 	MAR 0 3 198 6 	]
(Auth: HRS §§321-9, 	321-10) 	(Imp: HRS §§321-10, 	453-2)
§11-95-22 	Nuclear medical service. 	A nuclear medical
service, when provided by the facility, 	shall be under the direc-
tion of an appropriately qualified physician. 	There shall be
written policies covering procedures, 	and ongoing training,
in handling radioactive materials. 	Where ' applicable, 	provisions
of chapter 331, HRS, 	shall apply. 	[ Eff 	MAR 0 3 1986 	]
(Auth: 	HRS §§321-9, 	321-10) 	(Imp: 	HRS §§321-10, 	331-1 to 331-4)
§11-95-23 	Nursing service. 	(a) Each facility 	shall have
a nursing staff which shall be directed by the director of
nursing. 	The director of nursing shall be a qualified regi~ tered
professional nurse who shall be appointed by the administrator
with the approval of the governing body. 	The director of nursing
shall develop such nursing service policies and procedures,
recruit . such nursing personnel, 	and provide such supervision
as is necessary to achieve the objectives of the facility.
(b) 	Each facility shall have nursing staff sufficient in
number and qualifications to meet the nursing needs of the
patients in the facility. 	There shall be at least one registered
nurse present and on duty at all times the facility is open and
a patient is present in the facility. 	•
(c) 	There shall be an organized written departmental plan
which includes objectives, administrative authority, 	staffing
patterns, 	job descriptions, 	and responsibilities for each category
of nursing personnel.
(d) 	There shall be appropriate nursing policies and proce-
dures delineating the scope of services.
(e) 	Working personnel in each operating room must include
at least one registered professional nurse who shall serve as
the circulating nurse.
95-15
8 	2 3

§11-95-23
(f) 	If a general anesthetic is used, 	working personnel
in each recovery area shall include at least one registered pro-
fessional nurse. 	At least one such person must be physically
present and on duty at all times as long as any patients are
present in the facility.
(g) 	There shall be sufficient personnel on duty, 	as long
as a patient is present in the facility, 	to provide emergency
assistance in any area of the facility without violating sub-
sections (e) and 	(f). 	[Eff 	MAR 031986 	]
(Auth: HRS §§321-9, 	321-10) 	(Imp: HRS §§321-10, 	457-1)
§11-95-24 	Pathology. 	Examination of all tissues removed
at the time of operation shall be performed by a pathologist.
A report of the examination shall be placed in the patient's
medical record. 	Certain permitted procedures may be exempt from
this examination at the discretion of the director.
[Eff 	MAR O3 1986 	] 	(Auth: HRS _§§321-9,_ 321-10)
(Imp: HRS §321-10)
§11-95-25 	Patients' 	rights and patients' 	care. 	(a) All
patients admitted to the facility 	shall be under the care of
a medical staff member.
(b) 	An appropriate medical history and physical examination
shall be obtained within seventy-two hours prior to admission
of the patient. 	A record of these proce~ures shall be on the
patient's medical record within the facility prior to induction
of any • anesthesia or to the performance of any surgical procedure.
(c) 	Patients shall be observed in this facility for a
reasonable period of time to ensure that no immediate post-
operative complications are present. 	Thereafter, 	patients shall
be discharged at the discretion of the patient's physician.
If the patient's physician determines that the post-operative
observation period should extend beyond the closing time of the
facility, 	the patient shall be transferred to a hospital.
(d) 	At the time of the discharge from the facility, 	each
patient shall be provided with a document including as a minimum
the followi i g information.
(1) 	The exact procedure which was performed using accepted
medical terminology;
(2) 	The precise names, 	both generic and proprietary, 	of
the anesthetic used, 	as well as all . other drugs admini-
stered in the facility, 	or given to the patient at
the time of discharge;
(3) 	Symptoms of complications which might ensue from the
procedures carried on in the facility 	prior to
discharge;
95-16

§11.,-95-27
(4) 	Activities to be avoided by the patient;
(5) 	Specific telephone number, 	or numbers, 	of the operating
physician or dentist, 	as well as the telephone numbers
of at least one suitable back-up physician or dentist;
(6) 	The telephone number and locations.of the nearest
hospital, 	or hospitals, 	to be used by the patient should
complications arise. 	It shall be the responsibility
of the operating physician to provide this information;
(7) 	The date and location of the first post-operative check-
up to be required.
(e) 	Patient's rights:
(1) 	Written policies regarding the rights and responsibi-
lities of patients during their stay in the facility
shall be established by the governing body and shall
be made available to the patient, 	guardian, 	next of
kin, 	sponsoring agency, 	and to the public;
(2) 	All patients have the right to obtain from their physi-
cian complete current information concerning their
diagnosis, 	prognosis, 	and treatment in terms that can
be reasonably expected to be understood. 	When it is
not medically advisable to give such information to
the patient, 	the information shall be made available
to an appropriate person on the patient's behalf.
The patients are entitled to know, 	by name, 	the physi-
cian coordinating their care, 	as well as the physician
who actually performs any surgical procedure;
(3) 	Each patient or guardian is entitled to receive suffi-
cient information to give informed consent prior to
the start of any procedure or treatment. 	,
[Eff 	Mi1R 	] 	(Auth: HRS §§321-9, 	321-10)
(Imp: HRS §321-10)
§11-95-26 	Penalty. 	In addition to any other appropriate
action to enforce this chapter, 	the director may initiate proce-
dures for invoking penalties as provided in chapter 321, HRS.
[Eff 	1986 	] 	(Auth: HRS §§321-9, 	321-10)
(Imp: HRS §§321-10, 	321.,..18)
§11-95-27 	Pharmaceutical service. 	(a) Medicines shall not
be administered to patients unless ordered by a physician. 	The
orders shall be in writing or, 	if given orally, 	shall be promptly
reduced to writing and signed by the>physician prior to discharge
of the patient.
(b) 	Medicines maintained in the facility shall be appro-
priately stored and safeguarded against access by unauthorized
persons. 	Appropriate records shall be kept of the disposition
95-17

§11-95-27
of all medications.
(c) 	If medications are dispensed by the facility, 	the
dispensing shall be under the supervision of a pharmacist who
shall be employed either full time or part time as deemed appro-
priate by the director.
(d) 	Each facility 	shall maintain reference sources for
identifying and describing medications.
(e) 	Medicine shall be administered only by a licensed
nurse or physician.
(f) 	Blood, 	blood products, 	and parenteral solutions shall
be administered only by physicians, 	or registered nurses.
(g) 	Adverse drug reactions shall be reported immediately
to the physician responsible for the patient and this report
shall be documented in the medical record.
[Eff 	0 3 1985 	] (Auth: HRS §§321-9, 	321-10)
(Imp: 	§§321-10, 	329-38, 461-11, 	461-14)
§11-95-28 	Radiology service. 	The radiology service shall
be directd by a qualified radiologist and be staffed by qualified
technical personnel. 	There shall be written policies governing
all radiological procedures. 	Sufficient diagnostic and thera-
peutic radiological equipment shall be available to satisfy the
objectives of the facility. 	[Eff 	M'R n 	, . 	]
(Auth: HRS §§321-9, 	321-10) 	(Imp: 	HRt §§~~,i10, 	466J-4)
§11-95-29 	Social work service. 	At the time of discharge
from t~e facility, 	each patient, 	or another suitable person,
shall be provided with appropriate information concerning
community services which are available for home care needs.
[Eff 	] 	(Auth: HRS §§321-9, 	321-10)
(Imp:
§11-95-30 	Surgical facilities. 	(a) Each operating room
and surgical suite shall be appropriately equipped and supplied
for the types of procedures to be performed~
(b) 	E~ch recovery area shall be appropriately equipped
and supplied for the post-anesthetic recovery of surgical
patients.
(c) 	The following equipment and supplies shall be available
in all surgical and recovery areas:
(1) 	Cardiopulmonary resuscitative drugs and intubation
equipment;
(2) 	Cardiac monitor;
(3) 	Appropriate oxygen and suction equipment;
(4) 	Defibrillator;
95-18

§11-95-100
(5) 	Suitable anesthetic equipment customarily available
for all planned anesthetic procedures;
(6) 	Thorocotomy set including a chest tube and a water
seal bottle; 	and
(7) 	Tracheostomy set. 	[Eff 	]
(Auth: HRS §§321-9, 	321-10) 	(Imp: HRS §321-10)
§11-95-31 	Transfer agreement. 	The facility shall establish
transfer agreements which will expedite the transfer of patients
to hospitals when needed. 	There shall be documented evidence
that a local hospital has agreed to admit without delay, 	patients
from the facility, 	should the staff of the facility feel 	this
is advisable. 	[Eff 	1986 	] 	(Auth: HRS §§321-9,
321-10) 	(Imp: HRS §§127-9, 	321-10)
§11-95-33 through §11-95-99 reserved.
§11-95-100 	Severability. 	If any provision of this chapter
or the application thereof to any person or circumstances is
held invalid, 	the remainder of this chapter or the application
of the provisions to other persons or circumstances shall not
be affected thereby. 	[Eff. 	Mfi~ 	(Auth: HRS §§321-9,
321-10) 	(Imp: HRS 321-9, 	321-10)
95-19