South Carolina Code of Regulations
Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL
Subchapter 61-16 - Minimum Standards for Licensing Hospitals and Institutional General Infirmaries
Sec2 61-16.1200 - PATIENT CARE AND SERVICES
Section 61-16.1202 - Optional Hospital Services (I)
Universal Citation: SC Code Regs 61-16.1202
Current through Register Vol. 48, No. 9, September 27, 2024
A. Surgical Services.
If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered, the services must be consistent in quality with inpatient care in accordance with the complexity of services offered.
1. The organization
of the surgical services must be appropriate to the scope of the services
offered.
a. The operating rooms must be
supervised by an experienced registered nurse or a doctor of medicine or
osteopathy.
b. Licensed practical
nurses (LPNs) and surgical technologists (operating room technicians) may serve
as "scrub nurses" under the supervision of a registered nurse.
c. Qualified registered nurses may perform
circulating duties in the operating room. In accordance with applicable State
laws and approved medical staff policies and procedures, LPNs and surgical
technologists may assist in circulatory duties under the supervision of a
qualified registered nurse who is immediately available to respond to
emergencies.
d. Surgical privileges
must be delineated for all practitioners performing surgery in accordance with
the competencies of each practitioner. The surgical service must maintain a
roster of practitioners specifying the surgical privileges of each
practitioner.
2. Surgical
services must be consistent with needs and resources. Policies governing
surgical care must be designed to assure the achievement and maintenance of
high standards of medical practice and patient care.
a. Prior to surgery or a procedure requiring
anesthesia services and except in the case of emergencies:
i. A medical history and physical examination
must be completed and documented no more than 30 days before or 24 hours after
admission or registration, and except as provided under Section
1202.A.2.a.iii.
ii. An updated
examination of the patient, including any changes in the patient's condition,
must be completed and documented within 24 hours after admission or
registration when the medical history and physical examination are completed
within 30 days before admission or registration, and except as provided under
Section 1202.A.2.a.iii.
iii. An
assessment of the patient must be completed and documented after registration
(in lieu of the requirements of Section 1202.A.2.a.i and -ii) when the patient
is receiving specific outpatient surgical or procedural services and when the
medical staff has chosen to develop and maintain a policy that identifies
specific patients as not requiring a comprehensive medical history and physical
examination, or any update to it, prior to specific outpatient surgical or
procedural services.
b. A
properly executed informed consent form for the operation must be in the
patient's chart before surgery, except in emergencies.
c. The following equipment must be available
to the operating room suites: call-in-system, cardiac monitor, resuscitator,
defibrillator, aspirator, and tracheotomy set.
d. There must be adequate provisions for
immediate post-operative care.
e.
The operating room register must be complete and up-to-date.
f. An operative report describing techniques,
findings, and tissues removed or altered must be written or dictated
immediately following surgery and signed by the surgeon.
g. Hospitals shall provide surgical equipment
and instruments in good repair and free of potentially harmful microorganisms
to assure safe and aseptic treatment. Any indication of contamination shall be
immediately called to the attention of the nursing supervisor or the physician
in charge of the service.
B. Anesthesia Services.
1. Anesthesia shall be administered according
to the South Carolina Code of Laws and the South Carolina Code of State
Regulations by:
a. A qualified
anesthesiologist;
b. A doctor of
medicine or osteopathy other than an anesthesiologist;
c. A dentist, oral surgeon, or podiatrist who
is qualified to administer anesthesia under State law;
d. A certified registered nurse anesthetist
(CRNA), as defined in S.C. Code Ann. Section
40-33-20(20), is
under the supervision of the operating practitioner or of an anesthesiologist
who is immediately available if needed; or
e. An anesthesiologist's assistant, as
defined in S.C. Code Ann. Section
40-47-1210(2),
who is under the supervision of an anesthesiologist who is immediately
available if needed.
2.
The organization of anesthesia services must be appropriate to the scope of the
services offered.
3. Operations
under a general anesthetic shall not be performed nor a general anesthetic
given until the patient has had a physical examination except in emergency
situations. The results of these examinations shall be entered in the patient's
record. The history and physical must be readily available in the patient
medical record.
4. Anesthesia
apparatus shall be equipped with a device to measure the oxygen concentration
of the gas being inhaled by the patient. The device shall emit an audible
and/or visual alarm should the proportion of oxygen fall below a safe
level.
C. Nuclear Medicine Services.
If the hospital provides nuclear medicine services, those services must meet the needs of the patients in accordance with acceptable standards of practice.
1. The
organization of the nuclear medicine service must be appropriate to the scope
and complexity of the services offered.
a.
There must be a director who is a doctor of medicine or osteopathy qualified in
nuclear medicine.
b. The
qualifications, training, functions, and responsibilities of nuclear medicine
personnel must be specified by the service director and approved by the medical
staff.
2. Radioactive
materials must be prepared, labeled, used, transported, stored, and disposed of
in accordance with acceptable standards of practice.
a. In-house preparation of
radiopharmaceuticals is by, or under the supervision of, an appropriately
trained registered pharmacist or a doctor of medicine or osteopathy.
b. There is proper storage and disposal of
radioactive material.
c. If
laboratory tests are performed in the nuclear medicine service, the service
must meet the applicable requirement for laboratory services.
3. Equipment and supplies must be
appropriate for the types of nuclear medicine services offered and must be
maintained for safe and efficient performance. The equipment must be:
a. Maintained in safe operating condition;
and
b. Inspected, tested, and
calibrated at least annually by qualified personnel.
4. The hospital must maintain signed and
dated reports of nuclear medicine interpretations, consultations, and
procedures.
a. The hospital must maintain
copies of nuclear medicine reports for at least 5 years.
b. The practitioner approved by the medical
staff to interpret diagnostic procedures must sign and date the interpretation
of these tests.
c. The hospital
must maintain records of the receipt and disposition of
radiopharmaceuticals.
d. Nuclear
medicine services must be ordered only by a practitioner whose scope of Federal
or State licensure and whose defined staff privileges allow such referrals.
D. Outpatient Services.
If the hospital provides outpatient services, the services must meet the needs of the patients in accordance with acceptable standards of practice.
1. Outpatient services must
be appropriately organized and integrated with inpatient services.
2. The hospital must:
a. Assign one or more individuals to be
responsible for outpatient services.
b. Have appropriate professional and
nonprofessional personnel available where outpatient services are offered,
based on the scope and complexity of outpatient services.
3. Outpatient services must be ordered by a
practitioner who meets the following conditions:
a. Is responsible for the care of the
patient.
b. Is licensed in the
State where he or she provides care to the patient.
c. Is acting within his or her scope of
practice under State law.
d. Is
authorized in accordance with State law and policies adopted by the medical
staff, and approved by the governing body, to order the applicable outpatient
services. This applies to the following:
i.
All practitioners who are appointed to the hospital's medical staff and who
have been granted privileges to order the applicable outpatient
services.
ii. All practitioners not
appointed to the medical staff, but who satisfy the above criteria for
authorization by the medical staff and the hospital for ordering the applicable
outpatient services for their patients.
E. Rehabilitation Services.
If the hospital provides rehabilitation, physical therapy, occupational therapy, audiology, or speech pathology services, the services must be organized and staffed to ensure the health and safety of patients.
1. The organization of the
service must be appropriate to the scope of the services offered.
a. The director of the services must have the
necessary knowledge, experience, and capabilities to properly supervise and
administer the services.
b.
Physical therapy, occupational therapy, speech-language pathology or audiology
services, if provided, must be provided by qualified physical therapists,
physical therapist assistants, occupational therapists, occupational therapy
assistants, speech-language pathologists, or audiologists.
2. Services must only be provided under the
orders of a qualified and licensed practitioner who is responsible for the care
of the patient, acting within his or her scope of practice under State law, and
who is authorized by the hospital's medical staff to order the services in
accordance with hospital policies and procedures and State laws.
a. All rehabilitation services orders must be
documented in the patient's medical record.
b. The provision of care and the personnel
qualifications must be in accordance with national acceptable standards of
practice.
F. Psychiatric Services.
If the hospital provides psychiatric services, the services must be organized and staffed to ensure the health and safety of patients.
1. A physician, preferably a
board-certified psychiatrist, shall be designated as physician-in-charge (or
chief) of the psychiatric service. A designated physician who is experienced in
the practice of psychiatry should be on call at all times.
2. A registered nurse who has had at least
two years of training and/or experience in psychiatric nursing shall be
responsible for the nursing care of psychiatric patients. At least one
registered nurse shall be on duty in each nursing unit at all times.
3. Each patient must receive a psychiatric
evaluation that must:
a. Be completed within
60 hours of admission;
b. Include a
medical history;
c. Contain a
record of mental status;
d. Note
the onset of illness and the circumstances leading to admission;
e. Describe attitudes and behavior;
f. Estimate intellectual functioning, memory
functioning, and orientation; and
g. Include an inventory of the patient's
assets in descriptive, not interpretative, fashion.
4. Treatment plan:
a. Each patient must have an individual
comprehensive treatment plan that must be based on an inventory of the
patient's strengths and disabilities. The written plan must include:
i. A substantiated diagnosis;
ii. Short-term and long-range
goals;
iii. The specific treatment
modalities utilized;
iv. The
responsibilities of each member of the treatment team; and
v. Adequate documentation to justify the
diagnosis and the treatment and rehabilitation activities carried
out.
b. The treatment
received by the patient must be documented in such a way to assure that all
active therapeutic efforts are included.
5. Progress notes for the patient must be
documented, in accordance with applicable State scope-of-practice laws and
hospital policies, by the following qualified practitioners: Doctor(s) of
medicine or osteopathy, or other licensed practitioner(s), who is responsible
for the care of the patient; nurse(s) and social worker(s) (or social service
staff) involved in the care of the patient; and, when appropriate, others
significantly involved in the patient's active treatment modalities. The
frequency of progress notes is determined by the condition of the patient but
must be recorded at least weekly for the first 2 months and at least once a
month thereafter and must contain recommendations for revisions in the
treatment plan as indicated, as well as precise assessment of the patient's
progress in accordance with the original or revised treatment plan.
6. The record of each patient who has been
discharged must have a discharge summary that includes a recapitulation of the
patient's hospitalization and recommendations from appropriate services
concerning follow-up or aftercare as well as a brief summary of the patient's
condition on discharge.
G. Respiratory Care Services.
If the hospital provides respiratory care services, the services must be organized and staffed to ensure the health and safety of patients.
1. The organization of the
respiratory care services must be appropriate to the scope and complexity of
the services offered.
a. There must be a
director of respiratory care services who is a doctor of medicine or osteopathy
with the knowledge, experience, and capabilities to supervise and administer
the service properly. The director may serve on either a full-time or part-time
basis.
b. There must be adequate
numbers of respiratory therapists, respiratory therapy technicians, and other
personnel who meet the qualifications specified by the medical staff,
consistent with State law.
2. Services must be delivered in accordance
with medical staff directives.
a. Personnel
qualified to perform specific procedures and the amount of supervision required
for personnel to carry out specific procedures must be designated in
writing.
b. If blood gases or other
laboratory tests are performed in the respiratory care unit, the unit must meet
the applicable requirements for laboratory services.
c. Services must only be provided under the
orders of a qualified and licensed practitioner who is responsible for the care
of the patient, acting within his or her scope of practice under State law, and
who is authorized by the hospital's medical staff to order the services in
accordance with hospital policies and procedures and State laws.
d. All respiratory care services orders must
be documented in the patient's medical record.
H. Inpatient Dialysis Services.
If the hospital provides inpatient dialysis services, the services must be organized and staffed to ensure the health and safety of patients.
1. Written policies and
procedures shall be developed and maintained by the service provider
responsible for the service in consultation with other appropriate health
professionals and the administration. Procedures shall be approved by the
administration and medical staff where such is appropriate.
2. Renal Dialysis Service Equipment and
Supplies
a. Equipment and supplies shall
include at least:
i. A dialysis machine or
equivalent (with appropriate monitoring equipment) for each bed or station.
ii. Dialysis equipment appropriate
for pediatric patients, if treated.
b. Water used for dialysis purposes shall be
analyzed for bacteriological quality at least monthly and chemical quality at
least quarterly and treated as necessary to maintain a continuous water supply
that is biologically and chemically compatible with acceptable dialysis
techniques. Water used to prepare a dialysate shall not contain concentrations
of elements or organisms in excess of those specified below:
|
ELEMENTS |
LIMIT IN MILLIGRAMS PER LITER |
|
Aluminum |
.01 |
|
Arsenic |
.005 |
|
Barium |
.100 |
|
Cadmium |
.001 |
|
Calcium |
2.0 |
|
Chloramines (Tested Daily) |
.001 |
|
Chlorine (Tested Daily) |
.500 |
|
Chromium |
.014 |
|
Copper |
.100 |
|
Fluorides |
.200 |
|
Lead |
.005 |
|
Magnesium |
4.0 |
|
Mercury |
.0002 |
|
Nitrates (Nitrogen) |
2.0 |
|
Potassium |
8.0 |
|
Selenium |
.090 |
|
Silver |
.005 |
|
Sodium |
70.0 |
|
Sulfates |
100.0 |
|
Zinc |
.100 |
|
Bacteria |
200 colonies per milliliter |
c. A
written preventive maintenance program for all equipment used in dialysis and
related procedures including, but not limited to, all patient monitoring
equipment, isolated electrical systems, conductive flooring, patient ground
systems, and medical gas systems shall be developed and implemented. This
equipment shall be checked and/or tested at such intervals to ensure proper
operation and a state of good repair. After repairs and/or alterations are made
to any equipment or system, the equipment or system shall be thoroughly tested
for proper operation before returning it to service. Records shall be
maintained on each piece of equipment to indicate its history of testing and
maintenance.
I. Chemical and Substance Abuse Treatment Services.
If the hospital provides chemical and substance abuse treatment services, the services must be organized and staffed to ensure the health and safety of patients.
1. A
physician, who is experienced in the treatment of chemical and substance abuse,
shall be designated as physician-in-charge of this service. Such a physician
shall also be on call at all times.
2. A registered nurse who has had at least
two years training and/or experience in chemical and substance abuse care shall
be responsible for the nursing care of this service. At least one registered
nurse shall be on duty in each nursing unit at all times who has demonstrable
training in chemical and substance abuse treatment. Relevant content of this
training shall include physical and psychological assessment,
psychopharmacology, basic counseling and intervention techniques, and the role
of self-help groups in the recovery process. The training may be received
through on-the-job training, specialized workshops, or classroom experience.
J. Pediatric Services.
If the hospital provides pediatric services, the services must be organized and staffed to ensure the health and safety of patients.
1. Organization: Pediatric
services, if provided, shall be under the supervision of a registered
nurse.
2. Facilities: Pediatric
services shall have separate facilities for the care of children. Facilities
and procedures shall be provided for isolation of children having contagious
infections or communicable diseases.
3. Pediatric Nursery: Pediatric nurseries
shall provide at least 40 square feet per bassinet or 80 square feet per crib.
K. Cardiovascular Care Services.
1. Prior to establishing
or offering any cardiac catheterization or cardiac surgery services, the
hospital must have applied for and be in the process of obtaining accreditation
for such services from the American College of Cardiologists, Accreditation for
Cardiovascular Excellence, or other nationally recognized accrediting
organization approved by the Department with standards at least equal to those
of the Accreditation for Cardiovascular Excellence or American College of
Cardiologists. To continue offering such services, a hospital must obtain such
accreditation within two years from application unless otherwise approved by
the Department. Hospitals must maintain documentation evidencing their
application for accreditation and accreditation for such services. If a
hospital is denied accreditation or has its accreditation revoked, the hospital
must immediately notify the Department in writing, cease offering such
services, and cannot resume offering such services until the hospital is
accredited or re-accredited.
2.
Hospitals that offer cardiac catheterization services without onsite cardiac
surgery shall have written protocols ensuring immediate, efficient, and safe
transfer of patients to the nearest hospital with onsite cardiac surgery in the
case of an emergency.
Disclaimer: These regulations may not be the most recent version. South Carolina may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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