902 KAR 20:074. Operation and services;
outpatient health care center.
RELATES TO: KRS 194A.030(1),
211.842-211.852, 216B.010, 216B.015, 216B.040, 216B.042, 216B.045-216B.055,
216B.075, 216B.105-216B.131, 216B.176, 216B.177, 216B.990, Chapter 311, Chapter
314, 29 C.F.R. 1910.1030(d)(2)(vii), 42 C.F.R. 413.65, 42 U.S.C. 1320d-2
STATUTORY AUTHORITY: KRS 194A.050(1),
216B.042, 216B.105
NECESSITY, FUNCTION, AND CONFORMITY: KRS
216B.105 and 216B.042 require the Cabinet for Health and Family Services to
license and regulate health care facilities and health care services. This
administrative regulation provides licensure requirements for the operation of
and services provided by outpatient health care centers.
Section 1. Definitions. (1)
"Campus" means the physical area on which the licensee's main
administrative building, other areas and structures are located as well as that
physical area located, immediately adjacent to and within 250 yards of the main
administrative building.
(2) "Main provider" means a
licensed acute care hospital under which an outpatient health care center
functions as a subordinate and integral part, and which is under the same name,
ownership, and control as the outpatient health care center.
(3) "Outpatient health care
center" or "center" means a licensed health care facility that
is designated in the Certificate of Need State Health Plan as a primary care
center with outpatient diagnostic and surgical services, and which is certified
by the Centers for Medicare and Medicaid Services under 42 C.F.R. 413.65 as a
provider-based institution, with permanent facilities on a single campus that
is operated under the supervision of an organized medical staff and is
comprised of service components for the provision of primary care, ambulatory
surgery, twenty-four (24) hour emergency care, and radiological and magnetic
resonance imaging "MRI".
Section 2. Services. The center shall
provide component services that include primary care services, 24-hour
emergency services, diagnostic imaging including MRI, and ambulatory surgery
services on a single campus that is located in a county that has no hospital,
that has a population of 60,000 or more persons and that also is a
medically-underserved area as determined by the Secretary of the Federal Department
for Health and Human Services.
(1) A primary care component shall
include the following services, which shall be provided in the center or shall
be arranged through other providers with which the center has linkage agreements
in accordance with Section 7 of this administrative regulation:
(a) Basic health care services to
patients of all ages during normal hours of operation;
(b) A variety of preventative,
diagnostic, and therapeutic services of sufficiently broad scope to provide for
the usual and expected needs of patients in all age groups;
(c) Coordinated services for all other
health components in this administrative regulation; and
(d) Services established in Section 8(1)
of this administrative regulation.
(2) An ambulatory surgical care component
shall include:
(a) Ambulatory surgical services that, in
the professional judgment of the surgeon and the facility's medical director,
may be safely performed in the outpatient setting on a patient whose recovery under
normal circumstances shall not require inpatient care, observation-hold, or
convalescence in excess of twenty-three (23) hours;
(b) Follow-up care and services as
necessary for a surgical patient’s recovery; and
(c) Services established in Section 8(4)
of this administrative regulation.
(3) An emergency medical services
component shall include:
(a) Twenty-four (24) hour emergency
medical treatment by a board certified or board eligible emergency room
physician seven (7) days per week;
(b) A specific area for emergency
treatment that shall be located adjacent to an exterior entrance and is
immediately accessible to emergency transport vehicles;
(c) Facilities sufficient to assure
prompt diagnosis, treatment, and stabilization of injuries and trauma; and
(d) Services established in Section 8(2)
of this administrative regulation.
(4) A diagnostic imaging and MRI
component shall include:
(a) Radiologic and magnetic resonance
imaging with permanent, fixed-site equipment licensed or registered pursuant to
KRS 211.842 to 211.852 and 900 KAR 6:050, but shall not include any services
for which a separate certificate of need is required;
(b) Radiologic and imaging services shall
be provided in accordance with protocols established by the center, which shall
include a concise statement of the reason for the service; and
(c) Services established in Section 8(3)
of this administrative regulation.
Section 3. Administration and Operations.
(1) The licensee shall:
(a) Be legally responsible for the center
and for compliance with federal, state, and local laws and administrative
regulations pertaining to the operation of the center;
(b) Appoint a full-time administrator of
the center whose qualifications, responsibilities, authority, and
accountability shall be defined in writing and approved by the hospital governing
authority; and
(c) Be responsible for and assure
compliance with this administrative regulation, and make immediately available
for public inspection at the center all licensure and complaint inspection
reports and plans of correction pertaining to the last three (3) year survey
period.
(2) The administrator shall:
(a) Be responsible for the daily
operations of the center and shall delegate that responsibility in his absence;
(b) Assure the establishment and
implementation of written policies and procedures covering all aspects of the
center’s operation and, if appropriate, shall be consistent with the policies
and procedures of the main provider;
(c) Serve as liaison between the center,
its medical staff, and the main provider;
(d) Hold at least quarterly, component
and departmental staff meetings that shall include a discussion of
administrative and patient care standards;
(e) Ensure that a sufficient number of
trained staff are available to meet the needs of all persons who receive
services in the center; and
(f) Appoint a licensed physician to serve
as medical director who shall direct and coordinate all medical services and
oversee implementation of patient care standards and policies, who may serve as
the licensed physician in charge as established in Section 5(1)(a)1 of this
administrative regulation.
Section 4. Policies and Procedures. (1)
Development of policies and procedures. The administrator shall assure development
or adoption and implementation of the following policies and procedures:
(a) Administrative standards and policies
covering all aspects of the center's operation and specific to each component
part, including at least the following:
1. A description of organizational
structure, staffing, and allocation of responsibility and accountability within
each component part;
2. A description of referral linkages
with inpatient facilities and other providers;
3. A description of the component
services provided by the center;
4. Policies and procedures for the
guidance and control of personnel performance and quality assurance;
5. Policies and procedures for creation
and maintenance of administrative and patient care records and reports;
6. Policies for expense and accrual-based
revenue accounting system following generally-accepted accounting procedures;
7. Policies and procedures governing the
use of aseptic techniques in all areas of the center;
8. Policies and procedures for
sterilization of equipment and supplies;
9. Policies and procedures for disposal
of patient waste and other potentially-infectious materials; and
10. Policies and procedures for granting
and withdrawal of medical staff surgical privileges and privileges for the
administration of anesthetics.
(b) Patient care policies and standards,
which shall be developed by staff physicians and other qualified professional
staff, for all medical aspects of the center including:
1. Written protocols for standing orders,
rules of practice, and medical directives applying to each of the component services,
which shall be signed by the administrator and staff physician;
2. Patient care policies and standards
for patients held in the center's holding-observation area;
3. Patient care policies and standards
for primary care services;
4. Patient care policies and standards
for emergency medical services;
5. Patient care policies and standards
for ambulatory surgical services; and
6. Patient care policies and standards
for diagnostic imaging and magnetic resonance imaging services; and
(c) Patient rights policies which shall
be developed and assure that each patient is:
1. Informed of the patient’s rights and
facility responsibilities, including procedures for handling patient
grievances;
2. Informed of services available at the
center and any charges not covered under Medicare, Medicaid, or other
third-party payor arrangements;
3. Informed of his medical condition,
unless medically contraindicated and documented in the medical record, and is afforded
the opportunity to participate in the planning of medical treatment, the right
to refuse treatment, and informed consent;
4. Encouraged and assisted to understand
and exercise patient rights and the right to make grievances and receive a
response to a grievance;
5. Assured confidentiality in treatment,
care, and records, and is afforded the opportunity to approve or refuse release
of records to any individual not involved in his care except as required by Kentucky
law or third-party payment contract; and
6. Treated with consideration, respect, and
full recognition of his dignity and individuality, including privacy in
treatment, and in the care of his personal health needs.
(2) Accessibility of policies and
procedures. Written policies and procedures shall be maintained in the facility
in a readily-accessible electronic format or a written manual that is available
and conveniently accessible to all staff employed in the component service.
Section 5. Personnel and Qualifications.
(1) Personnel. The center shall have sufficient trained personnel to meet the
needs of each patient who presents for treatment at the center, which shall
include:
(a) At a minimum, a core center provider
team to coordinate services for the component services, composed of at least
one (1) licensed physician in charge, who may also serve as the center’s
medical director and the physician in charge of emergency medicine; one (1)
full-time registered nurse, who shall provide services within the scope of
practice; and other nursing personnel, aides, and technicians as required to
meet the needs of the patients, as follows:
1. A licensed physician shall be in
charge in the center twenty-four (24) hours a day, seven (7) days a week, who
shall be a physician in active practice and who shall be responsible for all
medical aspects of the center’s operation. The licensed physician in charge may
provide direct medical services in accordance with KRS Chapter 311.
2. The center shall employ or have contractual
or other linkage agreements with other physicians as necessary to meet the surgical
needs of the center’s patients, and who shall be qualified to practice general
medicine (e.g., general practitioner, family practitioner, obstetrician/gynecologist,
pediatrician, and internist), and who shall hold at least courtesy staff
privileges at one (1) or more hospitals with which the center has a formal
transfer agreement.
3. The registered nurse shall provide
nursing services within the scope of practice pursuant to KRS Chapter 314.
(b) At a minimum, a core ambulatory
surgery component provider team composed of one (1) licensed physician in
charge; other licensed physicians, dentists, or podiatrists, as necessary to
meet the surgical needs of the center’s patients; an anesthesiologist or nurse
anesthetist; a full-time registered nurse; and other nursing personnel, aides,
and technicians as required to meet the needs of the patients, as follows:
1. A licensed physician shall be in
charge of the ambulatory surgery component, and may also serve as the center’s
medical director. This physician shall be in active practice and shall either:
a. Have surgical privileges at the
provider-based hospital or one (1) or more hospitals with which the center has
a formal transfer agreement; or
b. Be a board-certified anesthesiologist
in active practice and be employed full time by the center or have a contract
to work full time at the center.
2. Surgical procedures shall be performed
by physicians who are legally authorized to perform these procedures and have
been granted privileges by the center through its medical staff or governing
body.
3. The ambulatory surgery registered
nurse shall be employed full-time and shall provide services within the scope
of practice pursuant to KRS Chapter 314.
4. Other nursing personnel, aides, and
technicians shall be employed to meet the needs of the patients. A registered
nurse shall be available during the surgical procedure and if a patient is in
recovery for patient care in the operating or post-anesthesia recovery room.
(c) At a minimum, the emergency medical component
shall be composed of a licensed physician, board certified in emergency
medicine or board eligible, who shall serve as director of emergency medicine;
at least one (1) full-time registered nurse; and other physicians and medical
staff who shall be available or on duty at all times for the emergency service,
as follows:
1. A licensed physician shall be present
in the center twenty-four (24) hours a day, seven (7) days a week, shall serve
as director of emergency services and may also serve as the center’s medical
director. The director of emergency medicine shall assure creation and
implementation of patient care policies, and assure at least the following:
a. Each patient presenting for or
requesting care shall be evaluated by a qualified physician or registered
nurse;
b. Qualified medical personnel shall be
available to treat a patient presenting for or requesting emergency care;
c. At least one (1) physician shall be
available on-site at all times to treat a patient;
d. Establishment and maintenance of a
manual of policies and procedures for emergency and nursing care provided in
the emergency room;
e. Nursing personnel shall be assigned to
or available to cover the emergency service at all times; and
f. Diagnostic and treatment equipment, drugs,
and supplies shall be readily available for the provision of emergency services
and shall be adequate in terms of the scope of services provided.
2. Physicians employed by or under
contract with the center to provide emergency medical treatment shall be board
certified in emergency medicine or board eligible.
3. Other nursing personnel, aides, and
technicians shall be available in the emergency department to meet the needs of
the patients who present for treatment.
(2) Center staffing and qualifications.
In addition to the core service component staff requirements, the center shall
employ sufficient numbers of qualified administrative and medical personnel to
provide prompt and effective patient care and services, and shall assure at
least the following:
(a) A written job description for each
position, which shall be reviewed and revised by the administrator as
necessary;
(b) An employee health program for mutual
protection of employees and patients, including provisions for preemployment
and periodic health examination;
(c) A tuberculosis skin test of each
staff member, which shall be implemented according to the following
requirements be documented in the employee's personnel record and which shall:
1. A test shall be initiated on each new
staff member before or during the first week of employment. The results shall
be documented in the employee's personnel record within the first month of employment,
unless the employee documents a prior skin test of ten (10) or more millimeters
of induration, or is currently receiving or has completed nine (9) months of
therapy for latent tuberculosis infection (LTBI) or a course of multiple-drug
chemotherapy for tuberculosis;
2. There shall be a two (2) step skin
testing for a new employee regardless of age whose initial test shows less than
ten (10) millimeters of induration, unless the employee can document that he
has had a tuberculosis skin test within one (1) year prior to his current employment;
3. A staff member who has never had a
skin test result of ten (10) or more millimeters induration shall be skin
tested annually, on or before the anniversary of the last skin test;
4. A staff member who has a skin test
result of ten (10) or more millimeters induration on initial employment or
annual testing shall receive a chest x-ray unless:
a. A chest x-ray within the previous two
(2) months showed no evidence of tuberculosis; or
b. The individual can document the
previous completion of a course of prophylactic treatment with Isoniazid. The employee
shall be advised of the symptoms of the disease and instructed to report to his
employer and to seek medical attention promptly if symptoms persist;
5. The following shall be reported by the
center administrator to the local health department having jurisdiction immediately
upon becoming known:
a. Names of staff who convert from a skin
test of less than ten (10) to a skin test of ten (10) millimeters or more
induration at the time of employment; and
b. Chest x-rays suspicious for
tuberculosis;
6. A staff member whose skin test status
changes on annual testing from less than ten (10) to ten (10) or more
millimeters of induration shall be considered to be recently infected with
Mycobacterium tuberculosis. A recently-infected person who has no sign or
symptom of tuberculosis disease on chest x-ray or medical history shall receive
preventative therapy with Isoniazid for six (6) months, unless medically
contraindicated, as determined by a licensed physician. Medication shall be
administered only upon the written order of a physician or other ordering
personnel acting within their statutory scope of practice. If an individual is
unable to take Isoniazid therapy, the individual shall be advised of the
clinical symptoms of the disease, and shall have an interval medical history
and a chest x-ray taken and evaluated for tuberculosis every six (6) months during
the two (2) years following conversation, for a total of five (5) x-rays; and
7. A staff member who documents
completion of preventive treatment with Isoniazid shall be exempt from further
screening requirements; and
(d) An employee file, which shall include
at least the following information for each employee:
1. Name, address, Social Security number;
2. Evidence of current professional
registration, certification, or licensure;
3. Complete record of training,
experience, and in-service;
4. Records of performance evaluation;
5. Records of incidents and accidents in
which the employee was involved; and
6. Documentation of current tuberculin
screening.
(3) Personnel in-service training. Center
personnel shall participate in quarterly in-service training programs relating
to their respective job duties and activities, which shall include at least the
following:
(a) Job orientation for new personnel and
recurring in-service training, including a requirement that each staff member
shall be knowledgeable of the center’s policies;
(b) Quarterly in-service training for all
staff emphasizing professional competence, quality assurance, policy development;
and the physical, nutritional, environmental, and social components necessary
for effective health care;
(c) Quarterly in-service training
pertaining to medical documentation and maintenance of medical records;
(d) Reporting, identifying, and
preventing abuse and neglect of children and adults; and
(e) Maintaining privacy and
confidentiality of patient-specific information and records.
Section 6. Medical Records. (1)
Maintenance of records. The center or the main provider shall maintain a
medical record at the center for each patient to include at least the
following:
(a) Medical and social history, including
data from other providers;
(b) Description of each medical visit or
contact, including identification of the condition or reason for the visit or
contact, assessment performed, medical diagnosis, services provided,
medications and treatments prescribed, and disposition;
(c) Reports of all laboratory, x-ray, and
other test findings;
(d) Documentation pertaining to a patient
referred to the center for treatment, including the reason for the referral, to
whom the patient was referred, and information obtained from the referral
source;
(e) Physicians’ orders, nurses’ notes,
and surgical and medical consent forms;
(f) History and physical examination
record prior to surgery;
(g) For surgical patients, the complete
medical record signed by the operating surgeon, including anesthesia record,
preoperative diagnosis, operative procedures and findings, postoperative diagnosis
and, if required, tissue diagnosis by a pathologist on specimens surgically
removed;
(h) Charts, including records of
temperature, pulse, respiration, and blood pressure; and
(i) Discharge summary completed at the
time of discharge which includes condition on discharge and post-treatment instructions
to the patient;
(2) Confidentiality. Confidentiality of
patient records shall be maintained at all times;
(3) Transfer of records. The center shall
establish systematic procedures to assist in continuity of care if the patient
moves to another provider of care, and the center shall, upon proper release,
transfer medical records or an abstract, if requested;
(4) Attending signature. The attending
physician shall complete and sign the medical record of each patient as soon as
practicable after discharge, but not to exceed ten (10) days; and
(5) Retention of records. Medical records
shall be maintained by the center for a period of five (5) years following the
last treatment, assessment, or visit made by the patient.
Section 7. Linkage Agreements. The center
shall have linkages through written agreements.
(1) Linkage agreements. Linkage
agreements shall be established with other providers of other levels of care
which may be medically indicated to supplement the services available in the center
and shall include:
(a) Hospitals;
(b) Emergency medical transportation
services in the service area;
(c) In-patient care facilities; and
(d) Other agreements as necessary.
(2) Inpatient agreements. Linkage
agreements with inpatient care facilities shall incorporate provisions for:
(a) Appropriate referral and acceptance
of patients from the center;
(b) Provisions for appropriate
coordination of discharge planning with center staff; and
(c) Provisions for the center to receive
a copy of the discharge summary for each patient referred to the center.
(3) Transfer agreements. The written
transfer agreements shall include designation of responsibility for:
(a) Transfer of information;
(b) Provision of transportation;
(c) Sharing of services, equipment, and personnel;
(d) Provision of total care or portions
thereof in relation to facility and agency capability; and
(e) Patient record confidentiality.
Section 8. Provision of Services. The
center shall provide the following component services on its campus:
(1) Primary care component. The center
shall provide at least the following services during scheduled hours of
operation that reasonably accommodate various segments of the population:
(a) Medical diagnostic and treatment
services of sufficiently broad scope to accommodate the basic health needs of
all age groups;
(b) Preventive health services of
sufficiently broad scope to provide for the usual and expected health needs of
persons in all age groups;
(c) Educational offerings in the
appropriate use of health services, preventive health services, and health
maintenance;
(d) Chronic illness management;
(e) Laboratory, x-ray, and treatment
services shall be provided directly or arranged through other providers; and
(f) Supplemental services may also be provided
for pharmacy, dentistry, optometry, nutrition, and counseling.
(2) Emergency services component. The
center shall have written policies for operation of the emergency component and
shall assure the following:
(a) A patient presenting for or requesting
emergency care shall be evaluated and triaged by a registered nurse or
emergency department physician in accordance with the center's formal operating
policies and procedures;
(b) The physician, in conjunction with
the administrator and other medical staff, shall establish and maintain
policies and procedures for emergency and nursing care, which shall assure
that:
1. Emergency services shall at all times
be under the direction of a licensed physician;
2. Sufficient medical staff shall be
available and on site at all times to perform emergency medical care in
accordance with accepted standards of practice; and
3. Current medical staff schedules and
telephone numbers shall be posted in the emergency treatment area;
(c) Sufficient nursing and medical
personnel shall be assigned to or designated to cover the provision of
emergency services at all times;
(d) Appropriate facilities shall be
provided to assure prompt diagnosis and emergency treatment for patients
requiring emergency care on arrival;
(e) Adequate diagnostic and treatment
equipment, drugs, and supplies shall be readily available for the provision of
emergency services;
(f) Adequate medical records shall be
kept for each patient seen in the emergency department, which shall include at
least:
1. A log listing the patient visits to
the emergency department in chronological order, including:
a. Patient identification;
b. Means of arrival;
c. Person transporting patient;
d. Time of arrival;
e. History of present complaint and
physical findings;
f. Laboratory and x-ray reports, if
applicable;
g. Diagnosis;
h. Treatment ordered and details of
treatment provided;
i. Patient disposition; and
j. Record of referrals.
2. Instructions to the patient or family
for those not admitted to the center; and
3. Signatures of attending medical staff
member, and nurse if applicable.
(3) Diagnostic imaging and MRI services.
The center shall have written policies for the operation of the component and
shall assure the following:
(a) The center shall have diagnostic
radiology facilities currently licensed or registered pursuant to KRS 211.842
to 211.852, the Kentucky Radiation Control Act of 1978;
(b) The center shall employ or contract
with a radiologist on at least a consulting basis to:
1. Function as the director of the
department; and
2. Interpret films requiring specialized
knowledge for accurate reading;
(c) The center shall employ and have on
duty sufficient personnel to supervise and conduct services, including one (1)
certified radiation operator who shall be on duty or on call at all times;
(d) Written policies and procedures
governing radiologic services and administrative routines that support sound
radiologic practices;
(e) Signed reports shall be filed in the
patient's record, and duplicate copies kept in the department;
(f) Radiologic services shall be
performed only upon written order of qualified personnel in accordance with
their scope of practice and the center's protocols and bylaws, and the order
shall contain a concise statement of the reason for the service or examination;
(g) Reports of interpretations shall be
written or dictated and signed by the radiologist;
(h) Only a certified radiation operator,
under the direction of medical staff, if necessary, shall use any x-ray
apparatus or material. Uses shall include application, administration, and
removal of radioactive elements, disintegration products, and radioactive isotopes.
A certified radiation operator under the direction of a physician may
administer medications allowed within his professional scope of practice and
the context of radiological services and procedures being performed; and
(i) The radiology department shall be
free of hazards for patients and personnel. Proper safety precautions shall be
maintained against fire and explosion hazards, electrical hazards, and
radiation hazards.
(4) Ambulatory surgical component
services. The center shall have written policies for the operation of the
component and shall assure the following:
(a) The patient or the patient's legal
representative shall sign a written informed consent prior to all surgical
operations;
(b) A medical history and physical
evaluation shall be performed and entered into the medical record no more than
thirty (30) days prior to surgery on a patient;
(c) Pertinent preoperative diagnostic
studies and laboratory tests shall be performed and made a part of the medical
record prior to surgery. The preoperative diagnosis shall be recorded in the
medical record;
(d) A patient shall be examined by a physician
immediately prior to surgery to evaluate the risk of anesthesia and of the procedure
to be performed, taking into account site of service, the invasive nature of
the procedure, and the need for extended postoperative recovery time or
monitoring;
(e) The center shall employ a registered
nurse who shall serve as operating room supervisor;
(f) A registered nurse shall be available
to circulate in the operating room at all times.
(g) A list of physicians with surgical
privileges at the center and the privileges assigned to each by the medical
staff shall be on file;
(h) The operating room shall have an
up-to-date operating room register;
(i) The operating room shall have
medically-appropriate supplies and equipment available at all times to meet the
needs of the patients, including the following:
1. Oxygen;
2. Mechanical ventilator assistance
equipment including airways, manual breathing bag, and ventilator;
3. Cardiac defibrillator,
4. Cardiac monitoring equipment,
5. Tracheostomy set,
6. Laryngoscopes,
7. Endotracheal tubes,
8. Suction equipment; and
9. Emergency medical equipment and
supplies specified by the medical staff;
(j) The operating room shall have on
hand, or make arrangements for obtaining, an adequate supply of blood in a timely
manner to meet the needs of each patient;
(k) Operating room administrative
regulations shall be posted;
(l) Physicians' orders shall be in
writing and signed by the physician;
(m) Except for cases requiring only local
infiltration anesthetics, a physician qualified to administer anesthesia, a
dentist qualified to administer anesthesia, or a registered nurse anesthetist
acting under the direction of the operating surgeon shall administer the anesthetics
and shall remain present during the surgical procedure and until the patient is
discharged to home or observation;
(n) The patient’s attending physician
shall be responsible for assuring that tissue removed during surgery is
delivered to the center's pathologist and that an examination and report is made
on the tissue, if required by the center's written policies;
(o) Voluntary interruption of pregnancy.
The center shall comply with the applicable Kentucky statutes, including KRS
311.710 to 311.810;
(p) The center shall have written surgery
policies and protocols that shall include:
1. Infection control policies addressing
the use of aseptic techniques and procedures for surgical patients;
2. Protocols for sterilization of
surgical equipment and supplies;
3. Protocols for disposal of patient
waste and other potentially-infectious materials;
4. Protocol for obtaining pathological
examination of tissues removed during surgery; and
5. Policies for granting and withdrawing
surgical privileges and privileges for the administration of anesthetics.
(q) The center shall have the following
postanesthesia recovery services:
1. At least one (1) postanesthesia
recovery unit;
2. Adequate staff available in the
recovery unit so that no patient is left alone at any time;
3. At least one (1) licensed physician shall
be present until all surgical patients are discharged;
4. A registered nurse shall be present in
the recovery unit while a patient is recovering from anesthesia;
5. A registered nurse shall be available
to the recovery unit at all times;
6. A person staffing the postanesthesia
recovery unit shall be adequately trained in all aspects of postoperative and
postanesthetic care; and
7. The recovery unit nurse shall record a
nursing note on the patient, noting the following:
a. Postoperative abnormalities or
complications;
b. Pulse;
c. Respiration;
d. Blood pressure;
e. Presence or absence of swallowing
reflex;
f. Cyanosis; and
g. The general condition of the patient.
(r) The ambulatory surgery component
shall assure the following equipment is available to the operating area:
1. Suction machine;
2. Stethoscope;
3. Sphygmomanometer;
4. Emergency crash cart;
5. Necessary drugs; and
6. Oxygen.
(s) The surgical center shall provide
suitable accommodations for its patients, including:
1. Adequate floor space, furnishings, bed
linens, and utensils, equipment, and supplies reasonably required for the
proper care and comfort of patients accommodated;
2. Holding-observation and convalescent
accommodations within the following limitations:
a. Holding-observation and convalescent
accommodations shall not exceed twenty-three (23) hours postadmission for
medical observation, recuperation, or convalescence in anticipation of discharge
to the patient's home;
b. The decision to hold a patient shall
be the responsibility of a physician on the medical staff of the center, who
shall document the reason for and duration of the hold in the patient's medical
record and shall date and sign the entry; and
c. A physician or registered nurse shall
be on duty at the center, if a patient is held in the center's accommodations beyond
regularly scheduled hours.
(5) Physical and sanitary environment.
(a) The condition of the physical plant
and the overall environment shall be maintained in such a manner that the safety
and well-being of patients, personnel, and visitors are assured.
(b) There shall be an infection control
committee charged with the responsibility of investigating, controlling, and
preventing infections. This committee shall develop written infection control
policies that are consistent with Centers for Disease Control guidelines and
include:
1. Prevention of disease transmission to
and from patients, visitors, and employees, including:
a. Universal blood and body fluid
precautions;
b. Precautions against airborne
transmittal of infections; and
c. Work restrictions for employees with
infectious diseases;
2. Use of environmental cultures. Culture
testing results shall be recorded and reported to the Infection Control Committee;
and
3. Cleaning, disinfection, and
sterilization methods used for equipment and the environment.
(c) The center shall provide in-service
education programs on the cause, effect, transmission, prevention, and
elimination of infections.
(d) The center’s buildings, equipment, and
surroundings shall be kept in a condition of good repair, neat, clean, free
from accumulation of dirt, rubbish, and foul, stale, or musty odors.
(e) Hazardous cleaning solutions,
compounds, and substances shall be labeled, stored in closed metal containers,
and kept separate from other cleaning materials.
(f) The facility shall be kept free from
insects and rodents, and their nesting places, and entrances shall be
eliminated.
(g) Garbage and trash:
1. Shall be stored in areas separate from
those used for preparation and storage of food;
2. Shall be removed from the premises
regularly; and
3. Containers shall be cleaned on a
regular basis.
(h) Sharp wastes:
1. Sharp wastes, including needles,
scalpels, razors, or other sharp instruments used for patient care procedures,
shall be segregated from other wastes and placed in puncture-resistant
containers immediately after use.
2. A needle or other contaminated sharp
shall not be purposely bent, broken, or otherwise manipulated by hand as a
means of disposal, except as permitted by Occupational Safety and Health Administration
guidelines at 29 C.F.R. 1910.1030(d)(2)(vii).
3. A sharp waste container shall be
incinerated or shall be rendered nonhazardous.
4. Nondisposable sharps, such as
large-bore needles or scissors, shall be placed in a puncture-resistant
container for transport to the Central Medical and Surgical Supply Department
in accordance with 902 KAR 20:009, Section 22.
(i) Disposable waste:
1. Disposable waste shall be placed in a
suitable bag or closed container so as to prevent leakage or spillage, and
shall be handled, stored, and disposed of in such a way as to minimize direct
exposure of personnel to waste materials.
2. The center shall establish specific
written policies regarding handling and disposal of waste material.
3. The following wastes shall receive
special handling:
a. Microbiology laboratory waste
including a viral or bacterial culture, contaminated swab, or a specimen
container or test tube used for microbiologic purposes shall be incinerated,
autoclaved, or otherwise rendered nonhazardous; and
b. Pathological waste including a tissue
specimen from a surgical or necropsy procedure shall be incinerated.
(6) Utilization review and medical audit.
In order to determine the appropriateness of the services delivered, the center
shall establish procedures for the medical audit and utilization review of services
provided in the center. The center may use professional capabilities and
assistance obtainable from other agencies and sources. There shall be a written
plan for utilization review developed by the center including frequency of review
and composition of the body conducting the review. (32 Ky.R. 2407; 33 Ky.R.
814; 1083; eff. 10-13-2006.)