reglab/statecodes huggingface dataset:
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.100 - DEFINITIONS, REFERENCES, AND LICENSE REQUIREMENTS › Section 61-91.100.102 - References

Current through Register Vol. 48, No. 6, June 28, 2024
The following publications/standards are referenced in this regulation:
A. Departmental:
1. R.61-4,
Controlled Substances
;
2. R.61-12,
Standards for Licensing Abortion Clinics
;
3. R.61-16,
Standards for Licensing Hospitals and Institutional General Infirmaries
;
4. R.61-20,
Communicable Diseases
;
5. R.61-25,
Retail Food Establishments
;
6. R.61-58,
State Primary Drinking Water Regulations
;
7. R.61-63,
Title A, Rules and Regulations for Radioactive Materials
;
8. R.61-64,
X-Rays, (Title B)
;
9. R.61-67,
Standards for Wastewater Facility Construction
;
10. R.61-105,
Infectious Waste Management Regulations
;
11. Guidelines for Prevention and Control of Antibiotic Resistant Organisms in Health Care Settings.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.200 - ENFORCING REGULATIONS › Section 61-91.200.201 - General

Current through Register Vol. 48, No. 6, June 28, 2024
The Department shall utilize inspections, investigations, consultations, and other pertinent documentation regarding a proposed or licensed facility in order to enforce this regulation.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.200 - ENFORCING REGULATIONS › Section 61-91.200.202 - Inspections/Investigations

Current through Register Vol. 48, No. 6, June 28, 2024
A. An inspection shall be conducted prior to initial licensing of a facility and subsequent inspections conducted as deemed appropriate by the Department. Other regulatory-related inspections may be considered in determining the appropriateness of Department inspections, e.g., Joint Commission on Accreditation of Health Care Organizations (JCAHO), Accreditation Association for Ambulatory Health Care (AAAHC), American Osteopathic Association (AOA), American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) inspections.
B. All facilities are subject to inspection or investigation at any time without prior notice by individuals authorized by the Department.
C. Individuals authorized by the Department shall be granted access to all properties and areas, objects, and records, and have the authority to require the facility to make photocopies of those documents required in the course of inspections or investigations. Photocopies shall be used for purposes of enforcement of regulations and confidentiality shall be maintained except to verify the identity of individuals in enforcement action proceedings. (II)
D. A facility found noncompliant with the standards of this regulation shall submit an acceptable written plan of correction to the Department that shall be signed by the administrator and returned by the date specified on the report of inspection or investigation. The written plan of correction shall describe: (II)
1. The actions taken to correct each cited deficiency;
2. The actions taken to prevent recurrences (actual and similar);
3. The actual or expected completion dates of those actions.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.300 - ENFORCEMENT ACTIONS › Section 61-91.300.301 - General

Current through Register Vol. 48, No. 6, June 28, 2024
When the Department determines that a facility is in violation of any statutory provision, rule, or regulation relating to the operation or maintenance of such facility, the Department, upon proper notice to the licensee, may impose a mandatory penalty and/or deny, suspend, and/or revoke its license.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.400 - POLICIES AND PROCEDURES › Section 61-91.400.401 - General (II)

Current through Register Vol. 48, No. 6, June 28, 2024
A. The Facility shall maintain and adhere to policies and procedures addressing each section of this regulation regarding care, treatment, procedures, surgery, and/or services, patient rights, and the operation of the facility. The policies and procedures shall follow current accepted standards of medical and surgical practice to ensure services are provided in a manner which protects the health and safety of patients. The Facility shall be in full compliance with the policies and procedures.
B. The Facility shall establish a time period for review, not to exceed two (2) years, of all policies and procedures, and such reviews shall be documented. The Facility shall ensure all policies and procedures are accessible to staff at all times, either by hard copy or electronically.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.500 - STAFF › Section 61-91.500.501 - General (II)

Current through Register Vol. 48, No. 6, June 28, 2024
A. A facility shall be fully staffed in sufficient numbers and training as required by this Section at all times a patient is in the facility or the facility is open to accept patients, in order to:
1. Effectively meet the needs and condition of the patients, to include the demands of effective emergency on-site action that might arise;
2. Properly operate equipment in accordance with the equipment manufacturer's recommendations;
3. Adhere to current professional organizational standards;
4. Comply with all local, state, and federal laws.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.500 - STAFF › Section 61-91.500.502 - Administrator (II)

Current through Register Vol. 48, No. 6, June 28, 2024
A. The facility shall have an administrator who shall be capable of meeting the responsibilities of operating the facility to ensure that it is in compliance with these regulations, and shall demonstrate adequate knowledge of these regulations. An administrator appointed subsequent to the promulgation of this regulation shall be a registered nurse or shall have a baccalaureate or associate degree with at least three years experience in a health-related field within the past five years.
B. A staff member shall be designated, by name or position, in writing, to act in the absence of the administrator.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.500 - STAFF › Section 61-91.500.503 - Control (I)

Current through Register Vol. 48, No. 6, June 28, 2024
The Facility must have a governing body designated in writing by the licensee that assumes full responsibility for determining, implementing, and monitoring policies governing the Facility's total operations. The governing body has oversight and accountability for the quality improvement program, and ensures that Facility policies and programs are administered so as to provide quality health care in a safe environment.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.500 - STAFF › Section 61-91.500.504 - Medical Director (II)

Current through Register Vol. 48, No. 6, June 28, 2024
A. There shall be a medical director of the facility who is a physician.
B. The administrator and medical director may be the same individual.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.500 - STAFF › Section 61-91.500.505 - Medical Staff (I)

Current through Register Vol. 48, No. 6, June 28, 2024
A. Physicians, dentists, and podiatrists performing surgery and/or procedures shall be appropriately licensed to perform these functions as well as adequately trained in any special requirements that are necessary to perform such surgery/procedures, including being board certified or board eligible.
B. Privileges for each physician, dentist, and podiatrist performing surgery/procedures shall be in accordance with criteria that the facility has established and approved.
C. There shall be a roster of medical staff having surgery, procedures, and anesthesia privileges at the facility, specifying the privileges and limitations of each and a current listing of all types of surgery and/or procedures offered by the facility.
D. A physician shall be physically present or available within 30 minutes until all patients have departed the premises.
E. There shall be at least one physician on staff who has admitting privileges at one or more hospitals.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.500 - STAFF › Section 61-91.500.506 - Nursing Staff (I)

Current through Register Vol. 48, No. 6, June 28, 2024
A. An adequate number of licensed nurses shall be on duty to meet the total nursing needs of patients.
B. At least one registered nurse shall be on duty whenever patients are present in the facility.
C. Nursing staff shall be assigned to duties consistent with their scope of practice as determined through their licensure and educational preparation.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.500 - STAFF › Section 61-91.500.507 - Advanced Cardiac Life Support (I)

Current through Register Vol. 48, No. 6, June 28, 2024
A. An individual who possesses a valid Advanced Cardiac Life Support credential shall be on duty in the facility whenever patients are present in the facility.
B. An individual who possesses a valid Pediatric Advanced Life Support credential shall be on duty in the facility whenever pediatric patients are present in the facility.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.500 - STAFF › Section 61-91.500.508 - Inservice Training (II)

Current through Register Vol. 48, No. 6, June 28, 2024
A. Training for the tasks each staff member performs shall be conducted in order to provide the care, treatment, procedures, surgery, and/or services delineated in Sections 501.A and 800.
B. The following training shall be provided to staff members by appropriate resources, e.g., licensed or registered persons, video tapes, books,
etc.
, to all staff members in context with their job duties and responsibilities, prior to patient contact and at a frequency determined by the facility, but at least annually:
1. Cause, effect, transmission, prevention, and elimination of infections, to include management and care of persons with contagious and/or communicable disease,
e.g.
, hepatitis, tuberculosis, HIV infection;
2. OSHA standards regarding bloodborne pathogens;
3. Confidentiality of patient information and records and the protection of patient rights;
4. Emergency procedures and disaster preparedness within 24 hours of their first day on the job in the facility (see Section 1200).
5. Fire response training within 24 hours of their first day on the job in the facility (see Section 1303);
6. Aseptic techniques such as handwashing and scrubbing practices, proper gowning and masking, dressing care techniques, disinfecting and sterilizing techniques, and the handling and storage of equipment and supplies.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.500 - STAFF › Section 61-91.500.509 - Health Status (I)

Current through Register Vol. 48, No. 6, June 28, 2024
A. All staff members who have contact with patients shall have, within 12 months prior to initial patient contact, a health assessment as defined in Section 101.R.
B. The health assessment shall include a tuberculin skin test as described in Sections 1505 and 1506.
C. If a staff member is working at multiple facilities operated by the same licensee, copies of records for tuberculin skin testing and the pre-employment health assessment shall be acceptable at each facility. (II)
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.600 - REPORTING › Section 61-91.600.601 - Incidents/Accidents (II)

Current through Register Vol. 48, No. 6, June 28, 2024
A. The licensee shall report a record of each accident and/or incident occurring at the facility to the Department within five (5) days of occurrence. Reports submitted to the Department shall contain only: facility name, license number, type of accident/incident, date of accident/incident occurred, number of patients directly injured or affected, patient medical record identification number, patient age and sex, number of staff directly injured or affected, number of visitors directly injured or affected, witness(es) name(s), identified cause of accident/incident, internal investigation results if cause unknown, a brief description of the accident/incident including location where occurred, and treatment of injuries. The report retained by the facility, in addition to the minimum reported to the Department, shall contain: names of patient(s), staff, and/or visitor(s), the injuries and treatment associated with each patient, staff, and/or visitor. Records of all accidents and incidents shall be retained by the facility for ten (10) years after the patient stops receiving services at the facility.
B. The licensee shall report each accident and/or incident resulting in unexpected death or serious injury to the next of kin or party responsible for each affected individual at the earliest practicable hour, not exceeding twenty-four (24) hours. The licensee shall notify the Department immediately, not to exceed twenty-four (24) hours, via telephone, email or facsimile. The licensee shall submit a report of the licensee's investigation of the accident and/or incident to the Department within five (5) days. Accidents and/or incidents requiring reporting include, but are not limited to,:
1. Surgical or Invasive Procedure Events
a. Surgery or other invasive procedure performed on the wrong site;
b. Surgery or other invasive procedure performed on the wrong patient;
c. Wrong surgical or other invasive procedure performed on a patient;
d. Unintended retention of a foreign object in a patient after surgery or other invasive procedure; and
e. Intraoperative or immediately/postprocedure death.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.600 - REPORTING › Section 61-91.600.602 - Fire/Disasters (II)

Current through Register Vol. 48, No. 6, June 28, 2024
A. The Department shall be notified immediately via telephone, email or facsimile regarding any fire in the facility, and followed by a complete written report, to include fire department reports, if any, to be submitted within a time-period determined by the facility, but not to exceed seventy-two (72) hours from the occurrence of the fire.
B. Any natural disaster that requires displacement of the patients or jeopardizes or potentially jeopardizes the safety of the patients, shall be reported to the Department via telephone, email or facsimile immediately, with a complete written report submitted within a time-period as determined by the facility, but not to exceed seventy-two (72) hours.
C. Where a required fire protection system is out of service, the facility shall notify the fire department and the fire code official immediately, and where required by the fire code official, the building shall either be evacuated or the facility shall provide an approved fire watch for all occupants left unprotected by the shut down until the fire protection system has been returned to service, as applicable to Division of Health Facilities Construction (DHFC) Guidelines Manual.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.600 - REPORTING › Section 61-91.600.603 - Communicable Diseases (I)

Current through Register Vol. 48, No. 6, June 28, 2024
All cases of diseases that are required to be reported to the appropriate county health department shall be accomplished in accordance with R.61-20.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.600 - REPORTING › Section 61-91.600.604 - Administrator Change

Current through Register Vol. 48, No. 6, June 28, 2024
The Department shall be notified in writing by the licensee within 10 days of any change in administrator. The notice shall include at a minimum the name of the newly-appointed individual, documented qualifications as required by Section 502, and the effective date of the appointment.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.600 - REPORTING › Section 61-91.600.605 - Joint Annual Report

Current through Register Vol. 48, No. 6, June 28, 2024
Facilities shall complete and return a "Joint Annual Report" to the Department's Planning and Certificate of Need Division within the time-period specified by that division.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.600 - REPORTING › Section 61-91.600.606 - Accounting of Controlled Substances (I)

Current through Register Vol. 48, No. 6, June 28, 2024
Any facility registered with the Department's Bureau of Drug Control and the federal Drug Enforcement Agency shall report any theft or loss of controlled substances to local law enforcement and to the Bureau of Drug Control within three working days of the discovery of the loss/theft. Any facility permitted by the S.C. Board of Pharmacy shall report the loss or theft of drugs or devices within three working days of the discovery of the loss/theft.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.600 - REPORTING › Section 61-91.600.607 - Facility Closure

Current through Register Vol. 48, No. 6, June 28, 2024
A. Prior to the permanent closure of a facility, the Department shall be notified in writing of the intent to close and the effective closure date. Within 10 days of the closure, the facility shall notify the Department of the provisions for the maintenance of the records. On the date of closure, the current original license shall be returned to the Department.
B. In instances where a facility temporarily closes, the Department shall be given written notice within a reasonable time in advance of closure. At a minimum this notification shall include, but not be limited to: the reason for the temporary closure, the manner in which the records are being stored, and the anticipated date for reopening. The Department shall consider, upon appropriate review, the necessity of inspecting and determining the applicability of current construction standards to the facility prior to its reopening. If the facility is closed for a period longer than one year, and there is a desire to re-open, the facility shall re-apply to the Department and shall be subject to all licensing requirements at the time of that application, including construction-related requirements for a new facility.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.600 - REPORTING › Section 61-91.600.608 - Zero Census

Current through Register Vol. 48, No. 6, June 28, 2024
In instances when there have been no patients in a facility for any reason, for a period of 90 days or more, the facility shall notify the Department in writing no later than the 100th day following the date of the last procedure/surgery performed. At the time of that notification, the Department shall consider, upon appropriate review of the situation, the necessity of inspecting the facility prior to any new and/or re-admissions to the facility. The facility shall still apply and pay the licensing fee to keep the license active despite being at zero census or temporarily closed. If the facility has no patients for a period longer than one year, and there is a desire to re-open, the facility shall re-apply to the Department and shall be subject to all licensing requirements at the time of that application, including construction-related requirements for a new facility.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.700 - PATIENT RECORDS › Section 61-91.700.701 - Content (II)

Current through Register Vol. 48, No. 6, June 28, 2024
A. The facility shall initiate and maintain an organized record for each patient. The record shall contain: sufficient documented information to identify the patient; the person responsible for each patient; the description of the diagnosis and the care, treatment, procedures, surgery, and/or services provided, to include the course of action taken and results; and the response and reaction to the care, treatment, procedures, surgery, and/or services provided. All entries shall be indelibly written, authenticated by the author, and dated.
B. Specific entries/documentation shall include at a minimum:
1. Consultations by physicians or other legally authorized healthcare providers;
2. Physical examination report, including pertinent medical history;
3. Orders and recommendations for all care, treatment, procedures, surgery, and/or services from physicians or other legally authorized healthcare providers, completed prior to, or at the time of patient arrival at the facility, and subsequently, as warranted;
4. Care, treatment, procedures, surgery, and/or services provided;
5. Record of administration of each dose of medication;
6. Medications administered and procedures followed if an error is made;
7. Special procedures and preventive measures performed,
e.g.
, isolation for symptoms of tuberculosis;
8. Notes of observation during recovery, to include vital signs pre- and post-operative;
9. Discharge summary, including condition at discharge or transfer, instructions for self-care and instructions for obtaining postoperative emergency care;
10. Special information,
e.g.
, allergies,
etc
. Documentation regarding organ donation shall be included in the record at the patient's request;
11. Signed informed consent;
12. If applicable, anesthesia records of pertinent preoperative and postoperative reports including pre-anesthesia evaluation, type of anesthesia, technique and dosage used, and post-anesthesia follow-up note;
13. Operative report (dictated or written into the record after surgery/procedure) to include at least:
a. Description of findings;
b. Techniques utilized to perform procedure/surgery;
c. Specimens removed, if applicable;
d. Primary surgeon and assistants.
14. Reports of all laboratory, radiological, and diagnostic procedures along with tests performed and the results appropriately authenticated.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.700 - PATIENT RECORDS › Section 61-91.700.702 - Authentication

Current through Register Vol. 48, No. 6, June 28, 2024
A. Each document generated by a user shall be separately authenticated.
B. Written signatures or initials and electronic signatures or computer-generated signature codes are acceptable as authentication.
C. In order for a facility to employ electronic signatures or computer-generated signature codes for authentication purposes, staff shall be identified who are authorized to authenticate patient records utilizing electronic or computer-generated signatures.
1. At a minimum, the facility shall provide authentication safeguards to ensure confidentiality, including, but not limited to, the following:
a. Each user shall be assigned a unique identifier that is generated through a confidential code;
b. The facility shall certify in writing that each identifier is kept strictly confidential. This certification shall include a user's commitment to terminate his or her use of an assigned identifier if it is found that the identifier has been misused, meaning that the user has allowed another person(s) to use his or her personally-assigned identifier, or that the identifier has otherwise been inappropriately utilized;
c. The user shall certify in writing that he or she is the only person with access to the identifier and the only person authorized to use the signature code.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.700 - PATIENT RECORDS › Section 61-91.700.703 - Record Maintenance

Current through Register Vol. 48, No. 6, June 28, 2024
A. The licensee shall provide accommodations, space, supplies, and equipment adequate for the protection, security, and storage of patient records.
B. When a patient is transferred to an emergency facility, a transfer summary to include, at a minimum, the diagnosis and medication administration record, shall accompany the patient to the receiving facility at the time of transfer or forwarded immediately after the transfer. Documentation of the information forwarded shall be maintained in the facility's patient record. (I)
C. The patient record is confidential. Records containing protected or confidential health information shall be made available only to individuals granted access to that information, in accordance with state and federal laws. The facility shall have a written policy designating the persons allowed to access confidential patient information. (II)
D. Records generated by organizations or individuals contracted by the facility for care, treatment, procedures, surgery, and/or services shall be maintained by the facility that has admitted the patient. Appropriate information shall be provided to assure continuity of care.
E. The facility shall determine the medium in which information is stored. The information shall be readily retrievable and accessible by facility staff, as needed, and for regulatory compliance inspections.
F. Upon discharge of a patient, the record shall be completed within 60 days and filed in an inactive/closed file maintained by the licensee. Prior to the closing of a facility for any reason, the licensee shall arrange for preservation of records to ensure compliance with these regulations and other applicable law. The licensee shall notify the Department, in writing, describing these arrangements and the location of the records.
G. Records of patients shall be maintained for at least six years following the discharge of the patient. Other documents required by the regulation,
e.g.
, fire drills, shall be retained at least 12 months or until the next Department inspection, whichever is longer.
H. Patient records are the property of the facility; the original record shall not be removed without court order. (II)
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.800 - CARE/TREATMENT/PROCEDURES/SURGERY/SERVICES › Section 61-91.800.801 - General (I)

Current through Register Vol. 48, No. 6, June 28, 2024
A. Care, treatment, procedures, surgery, and/or services shall be provided, given, or performed effectively and safely in accordance with orders from physicians or other legally authorized healthcare providers, and precautions shall be taken for patients with special conditions,
e.g.
, pacemakers, pregnancy, Alzheimer's disease, etc., and/or for those who may be susceptible to deleterious effects as a result of the treatment.
B. The facility shall comply with all current federal, state, and local laws and regulations related to patient care, treatment, procedures, surgery, and/or services, and protection.
C. When a facility engages a source other than the facility to provide services normally provided by the facility,
e.g.
, staffing, training, food service, maintenance, housekeeping, there shall be a written agreement with the source that describes how and when the services are to be provided, the exact services to be provided, and a statement that these services are to be provided by qualified individuals. The source shall comply with this regulation in regard to patient care, treatment, procedures, surgery, and/or services, confidentiality, and rights. (II)
D. The Facility shall have a written transfer agreement with one (1) or more hospitals that provides reasonable assurance that transfer of patients will be made between the hospital and the facility. The transfer agreement shall be dated and signed by authorized officials who are a party to the agreement. The agreement shall be updated following a change of Administrator; the agreement shall be updated following changes in licensee or at any other time as deemed advisable to maintain or further improve continuity of care.
Exception: A facility which has attempted, but has been unable to secure such an agreement shall maintain documentation of its efforts, and shall provide the local hospitals written notice of its hours of operation and patient population.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.800 - CARE/TREATMENT/PROCEDURES/SURGERY/SERVICES › Section 61-91.800.802 - Physical Examination (I)

Current through Register Vol. 48, No. 6, June 28, 2024
A. A preoperative history and physical examination, pertaining to the procedure to be performed, shall be completed by a physician or legally authorized healthcare provider no earlier than 14 days prior to surgery/procedure, or 30 days prior to surgery/procedure with the condition that, on the day of surgery/procedure, the physician or legally authorized healthcare provider documents no notable changes in the original history and physical examination. If notable changes are discovered at that time, a history and physical examination shall be completed. A discharge summary from a health care facility that includes a history and physical examination may be acceptable as the preoperative history and physical examination, provided the summary is within the time requirements of this section, and is reviewed by the physician or legally authorized healthcare provider performing the surgery/procedure.
B. If a patient or potential patient has a communicable disease, a physician or other legally authorized healthcare provider shall insure that the facility has the capability to provide adequate care and prevent the spread of the disease, and that the staff members are adequately trained and qualified to manage the patient, or transfer the patient to an appropriate facility, if necessary.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.800 - CARE/TREATMENT/PROCEDURES/SURGERY/SERVICES › Section 61-91.800.803 - Surgical Services

Current through Register Vol. 48, No. 6, June 28, 2024
If surgical services are provided, a current listing of all types of surgical services offered by the facility shall be available.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.800 - CARE/TREATMENT/PROCEDURES/SURGERY/SERVICES › Section 61-91.800.804 - Anesthesia Services (I)

Current through Register Vol. 48, No. 6, June 28, 2024
A. Anesthesia shall be administered only by:
1. An anesthesiologist;
2. A physician, other than an anesthesiologist, or dentist, or podiatrist who is qualified to administer anesthesia pursuant to the S.C. Code of Laws;
3. A certified registered nurse anesthetist; or
4. An anesthesiologist's assistant.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.800 - CARE/TREATMENT/PROCEDURES/SURGERY/SERVICES › Section 61-91.800.805 - Laboratory Services (II)

Current through Register Vol. 48, No. 6, June 28, 2024
A. Each facility shall provide or make arrangements for obtaining laboratory services required in connection with the surgery/procedure to be performed.
B. Should the facility conduct tests that involve human specimens by utilizing any laboratory equipment such as finger-stick glucose, hemoglobin, monitoring devices,
etc.
, for the purpose of providing information for the diagnosis, prevention, or treatment of disease or impairment, or assessment of health, the facility shall obtain a Certificate of Waiver from the Clinical Laboratories Improvement Amendments (CLIA) Program through the Department's CLIA Program.
C. Laboratory supplies shall not be expired.
D. A pathologist shall examine all surgical specimens except for those types of specimens that the medical staff has determined and documented do not require examination.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.800 - CARE/TREATMENT/PROCEDURES/SURGERY/SERVICES › Section 61-91.800.806 - Radiology Services (II)

Current through Register Vol. 48, No. 6, June 28, 2024
A. Each facility shall have the capability of providing or obtaining diagnostic radiology services in connection with the surgery/procedure to be performed.
B. Those facilities where radiological equipment and materials are used shall be in compliance with R.61-63 and R.61-64.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.800 - CARE/TREATMENT/PROCEDURES/SURGERY/SERVICES › Section 61-91.800.807 - Cardiovascular Care Services

Current through Register Vol. 48, No. 6, June 28, 2024
A. Prior to establishing or offering invasive cardiac procedures, including cardiac catheterization services, a facility 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 providing such services, a facility must obtain such accreditation within two years from application unless otherwise approved by the Department. Facilities must maintain documentation evidencing their application for accreditation and accreditation for such services. If a facility is denied accreditation or has its accreditation revoked, the facility must immediately notify the Department in writing, cease offering such services, and cannot resume offering such services until the facility is accredited or re-accredited.
B. Facilities that offer cardiac catheterization services 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.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.800 - CARE/TREATMENT/PROCEDURES/SURGERY/SERVICES › Section 61-91.800.808 - Adverse Conditions (I)

Current through Register Vol. 48, No. 6, June 28, 2024
Patients in whom any adverse condition exists or in whom a complication is known or suspected to have occurred during or after the performance of the operative procedure shall remain in the facility until the condition/complication is eliminated, as determined by the physician, and the patient is stabilized. Patients requiring care for periods in excess of those set forth in Section 101.RR shall be transferred to a hospital.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.800 - CARE/TREATMENT/PROCEDURES/SURGERY/SERVICES › Section 61-91.800.809 - Patient Instruction (I)

Current through Register Vol. 48, No. 6, June 28, 2024
Written instructions shall be issued to all patients upon discharge and shall include, at a minimum, the following:
A. Signs and symptoms of possible complications;
B. Telephone number of the facility or the attending physician or other knowledgeable professional staff member from the facility should any complication occur or question arise;
C. An emergency telephone number should any complication occur. It shall be the responsibility of the attending physician to arrange for needed care;
D. Limitations regarding activities, foods,
etc.
;
E. Date for follow-up or return visit, if applicable.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.900 - RIGHTS AND ASSURANCES › Section 61-91.900.901 - General (II)

Current through Register Vol. 48, No. 6, June 28, 2024
A. The facility shall comply with all current federal, state, and local laws and regulations concerning patient care, treatment, procedures, surgery, and/or services, patient rights and protections, and privacy and disclosure requirements.
B. The facility shall comply with all relevant federal, state, and local laws and regulations concerning discrimination,
e.g.
, Title VII, Section 601 of the Civil Rights Act of 1964, and insure that there is no discrimination with regard to source of payment in the recruitment, location of patient, acceptance or provision of services to patients or potential patients, provided that payment offered is not less than the cost of providing services.
C. The facility shall develop and post in a conspicuous place in a public area of the facility a grievance/complaint procedure to be exercised on behalf of the patients that includes the address and phone number of the Department and a provision prohibiting retaliation should the grievance right be exercised.
D. Care, treatment, procedures, surgery, and/or services provided by the facility, and the charges for such, shall be delineated in writing. Patients shall be made aware of such charges and services, as verified by the signature of the patient or responsible party.
E. Patients shall be permitted to use the telephone and allowed privacy when making calls.
F. Adequate safeguards shall be provided for protection and storage of patients' personal belongings.
G. Patient rights shall be guaranteed, prominently displayed, and the facility shall inform the patient of these rights, to include, at a minimum:
1. The care, treatment, procedures, surgery, and/or services to be provided;
2. Informed consent for care, treatment, procedures, surgery, and/or services;
3. Respect for the patient's property;
4. Freedom from mental and physical abuse and exploitation;
5. Privacy while being treated and while receiving care;
6. Respect and dignity in receiving care, treatment, procedures, surgery, and/or services;
7. Refusal of treatment. The patient shall be informed of the consequences of refusal of treatment, and the reason shall be reported to the physician and documented in the patient record;
8. Refusal of experimental treatment and drugs. The patient's written consent for participation in research shall be obtained and retained in his or her patient record;
9. Confidentiality and privacy of records. Written consent by the patient shall be obtained prior to release of information except to persons authorized by law. If the patient is mentally incompetent, written consent is required from the patient's responsible party. The facility shall establish policies to govern access and duplication of the patient's record.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.1000 - MEDICATION MANAGEMENT › Section 61-91.1000.1001 - General (I)

Current through Register Vol. 48, No. 6, June 28, 2024
A. Medications, including controlled substances, medical supplies, intravenous solutions, and those items necessary for the rendering of first aid shall be properly managed in accordance with local, state, and federal laws and regulations, to include the securing, storing, and administering of medications, medical supplies, first aid supplies, biologicals and their disposal when discontinued or expired, or at discharge, death, or transfer of a patient.
B. Non-legend medications that can be obtained without a prescription may be retained and labeled as stock in the facility for administration as ordered by a physician or other legally authorized healthcare provider.
C. If controlled substances are to be used, a controlled substances registration from the Department's Bureau of Drug Control and a controlled substance registration from the federal Drug Enforcement Administration (DEA) shall be obtained. The registration(s) shall be displayed in a conspicuous location within the facility.
D. Each facility shall maintain, upon the advice and written approval of the Medical Director or consultant pharmacist, an emergency kit/cart of lifesaving medicines and equipment for the use of physicians or other legally authorized healthcare providers in treating the emergency needs of patients.
1. The kit/cart shall be sealed and stored in such a manner as to prevent unauthorized access and to ensure a proper environment for preservation of the medications within, but in such a manner as to allow immediate access.
2. The exterior of each emergency medication kit/cart shall have displayed the following information:
a. "For Emergency Use Only";
b. Name, address, and telephone number of the consultant pharmacist.
3. Whenever the kit/cart is opened, it shall be restocked and resealed within a reasonable time to prevent risk of harm to a patient.
4. Medications used from the kit/cart shall be replaced pursuant to orders from a physician or other legally authorized healthcare provider according to facility policy.
5. Contents of each section of the kit/cart shall be listed and maintained on or in the kit/cart, and shall correspond to the list. Documentation of monthly checks of expiration dates of medications and supplies is to be retained by the facility for a period of two years or until the Department's next inspection, whichever is longer.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.1000 - MEDICATION MANAGEMENT › Section 61-91.1000.1002 - Medication Orders (I)

Current through Register Vol. 48, No. 6, June 28, 2024
A. Medications, to include oxygen, shall be administered in the facility to patients only upon orders of a physician or other legally authorized healthcare provider.
B. All orders (including verbal) shall be received only by licensed nurses or authorized healthcare providers, and shall be authenticated and dated by a physician or other legally authorized healthcare provider pursuant to the facility's policies and procedures, but no later than 72 hours after the order is given. Verbal orders received shall include the time of receipt of the order, description of the order, and identification of the physician or other legally authorized healthcare provider and the individual receiving the order.
C. Medications and medical supplies ordered for a specific patient shall not be provided to or administered to any other patient.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.1000 - MEDICATION MANAGEMENT › Section 61-91.1000.1003 - Administering Medication (I)

Current through Register Vol. 48, No. 6, June 28, 2024
A. Each medication dose administered shall be properly recorded in the patient's record as the medication is administered. The medication administration record shall include the name of the medication, dosage, mode of administration, date, time, and the signature of the individual administering the medication. Initials may be utilized when recording administration, provided identification of the individual's initials is located within the record.
B. Expired medications shall not be administered to patients.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.1000 - MEDICATION MANAGEMENT › Section 61-91.1000.1004 - Pharmacy Services (I)

Current through Register Vol. 48, No. 6, June 28, 2024
Facilities that maintain stocks of legend medications and biologicals for patient use within the facility shall obtain and maintain from the S.C. Board of Pharmacy a valid, current, nondispensing drug outlet permit, displayed in a conspicuous location in the facility, and have a consultant pharmacist on-call during facility operating hours.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-91 - Standards for Licensing Ambulatory Surgical Facilities › Sec2 61-91.1000 - MEDICATION MANAGEMENT › Section 61-91.1000.1005 - Medication Containers (I)

Current through Register Vol. 48, No. 6, June 28, 2024
Medications for each patient shall be dispensed from their original container(s), to include unit dose systems. There shall be no transferring between containers or opening blister packs to remove medications for destruction or adding new medications for administration, except by direction of a pharmacist.