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South Carolina
Department of Health and
Environmental Control (DHEC)
Selected Regulations – Chapter 61
(Adapted from South Carolina's Legislature website)

TABLE OF CONTENTS
Selected Rules Addressing Medical Accidents / Incidents

Chapter 61 - Department of Health
Section
 
Description
Chapter 12 – Abortion Clinics
Reports.
Chapter 13 – Habilitation Centers for the Mentally Retarded
Definitions.
Management, Reports and Records.
Chapter 16 – Hospitals
Interpretations
Reports.
Nursing Procedures.
Chapter 17 – Nursing Homes
Definitions and interpretations
Management. – Reports and Records.
Pharmaceutical Services
Chapter 75 – Adult Day Care Facilities
Incidents and Accidents Reports
Chapter 78 – Hospice
Incidents / Accidents
Patient Death
Fire / Disasters
Chapter 84 – Community Residential Care Facilities
Incidents / Accidents
Fire / Disasters
Chapter 90 – Chiropractic Facilities
Reports
Chapter 91 – Ambulatory Surgical Centers
Violation Classification
Incidents / Accidents
Fire / Disasters
Chapter 93 – Substance-Abuse Facilities
Incidents / Accidents
Fire / Disasters
Chapter 97 – Renal Dialysis Facilities
Incidents and Accident Reporting
Chapter 103 – Residential Treatment Facilities for Children/Adolescents
Governing Authority and Management - Administative Records
Chapter 108 – Standards for Licensing Freestanding or Mobile Technology
Incidents / Accidents
Fire / Disasters
Chapter 109 – Body Piercing Facilities
Incidents/Accidents
Fire / Disasters
 
PDF – 1996 Policy Statement and Reportable Incident / Accident Form from DHCE

61-12. Standards for Licensing Abortion Clinics.

Part IV - Medical Records and Reports
Section 403. Reports. (II)

  • A. The following shall be reported to Vital Records and Public Health Statistics of this Department:
    • 1. Any abortion performed, to be reported by the performing physician on the standard form for reporting abortions, within seven days after the abortion is performed;
    • 2. A fetal death when the fetus has completed or passed the age or weight requiring a report, pursuant to the standards in Department R. 61-19, Vital Statistics.
  • B. A record of each accident or incident occurring in the facility which involves patients, staff, or visitors, including medication errors and adverse drug reactions, shall be prepared immediately. Accidents or incidents resulting in serious injury shall be reported, in writing, to the Department within 10 days of the occurrence; if a death occurs, other than a fetal death, it shall be reported to the Department not later than the next Department work day (Monday through Friday). Accidents and incidents that must be reported include, but are not limited to:
    • 1. Those leading to hospitalization;
    • 2. Those leading to death, other than a fetal death;
    • 3. Adverse drug reactions.

61-13. Standards for Licensing Habilitation Centers for the Mentally Retarded or Persons with Related Conditions.

61-13 A. Definitions and Interpretations. – Section 1. Definitions

  • (1) Definitions: For the purpose of these standards the following definitions shall apply:
    • (a)  "Accident/Incident" shall be considered as, but not limited to, medication errors, adverse drug reactions, missing residents, and verbal or written threats to harm the health and welfare of the residents.
    • - - - 

61-13 B. Management – Section 7. Reports and Records

  • (7) Reports & Records
    • (a) Accidents/Incident Reports: A record of each accident and/or incident, involving clients, staff or visitors, occurring in the facility or on facility grounds shall be retained. Accidents/Incidents resulting in death or serious injury shall be reported in writing to the Division of Health Licensing within 10 days of the occurrence.
    • (b) Serious injuries shall be considered as, but not limited to, fractures of major limbs or joints, severe burns, severe lacerations, severe hematomas, and suspected abuse.
    • (c) All accidents/incidents shall be reviewed, investigated if necessary and evaluated in accordance with facility policy.
    • (d) Monthly Statistical Record: An accurate and up-to-date monthly statistical record shall be kept and must contain at least the following information: name; case number; age; sex; dates of admission, discharge or death; and days of care rendered during the month.
    • (e) The Department requires each health care facility to annually complete a questionnaire named “Joint Annual Report” and to return this report within the time period as specified in the report's accompanying cover letter.
    • (f) Fire Reports: A complete written report regarding every fire regardless of size or damage that occurs in the facility shall be prepared and promptly submitted to the Department within 10 days of the fire.

61-16. Minimum Standards for Licensing Hospitals and Institutional General Infirmaries.

Section 102. INTERPRETATIONS

  • F. Inspections. Each facility shall be inspected prior to initial licensure and at least annually thereafter by authorized representatives of the Department.
    • 1. All licensed facilities are subject to inspection at any time.
    • 2. Department inspectors shall have access to all properties and areas, objects, records and reports, and shall have the authority to make photocopies of those documents required in the course of inspections or investigations. (II)

61-16. Minimum Standards for Licensing Hospitals and Institutional General Infirmaries.

Section 101. DEFINITIONS

For the purpose of these Standards, the following definitions shall apply:

  • A.  The Department:

    The South Carolina Department of Health and Environmental Control

  • B.  Licensee:

    The "licensee" is the individual with whom rests the ultimate responsibility for maintaining approved standards for the facility.

  • C.  Patient:

    The term "patient" shall mean any individual who is being treated by a physician in a hospital.

  • D.  Definition of Facilities:

    For administrative purposes, hospitals and institutional general infirmaries in South Carolina which are subject to licensure laws as required by Section 44-7-310 of the Code of Laws of South Carolina, of 1976, shall be defined and classified as follows:

    • 1.  General Hospital:

      A "general hospital" is a facility with an organized medical staff to maintain and operate organized facilities and services to accommodate two or more nonrelated persons for the diagnosis, treatment and care of such persons over a period exceeding 24 hours and provides medical and surgical care of acute illness, injury or infirmity and may provide obstetrical care, and in which all diagnoses, treatment or care are administered by or performed under the direction of persons currently licensed to practice medicine and surgery in the State of South Carolina.

    • 2.  Specialized Hospital:

      A "specialized hospital" is a facility which has an organized medical staff, maintains and operates organized facilities and services to accommodate two or more nonrelated persons for the diagnosis, treatment and/or care of such persons over a period exceeding 24 hours and which provides a specialized service for one type of care, such as tuberculosis, maternity, orthopedics, pediatrics, E.E.N.T., etc., and in which all diagnoses, treatment or care are administered by or performed under the direction of persons currently licensed to practice medicine and surgery in the State of South Carolina.

    • 3.  Institutional General Infirmary:

      A "institutional general infirmary" is a facility which is established within the jurisdiction of a larger nonmedical institution and which maintains and operates organized facilities and services to accommodate two or more nonrelated students, residents or inmates with illness, injury or infirmity for a period exceeding 24 hours for the diagnosis, treatment and care of such persons and which provides medical, surgical and professional nursing care, and in which all diagnoses, treatment and care are performed under the direction of persons currently licensed to practice medicine in the State of South Carolina.

    • 4.  Chronic Hospital:

      A "chronic hospital" is a facility which has an organized medical staff and provides skilled nursing and other services in facilities designed and equipped for diagnosis and treatment over a period exceeding 24 hours of two or more non-related persons who have chronic diseases. This includes, as a minimum, diagnostic x-ray service, minor surgery, clinical laboratory and rehabilitation services if the licensee does not already operate these services in a physically attached facility.

    • 5.  Public Health Centers:

      A "public health center" means a publicly owned facility for the provision of public health services, including related facilities such as laboratories, clinics and administrative offices operated in connection with such facilities.

    • 6.  Diagnostic and Treatment Centers:

      The term "diagnostic or treatment center" means a facility for the diagnosis and treatment of ambulatory patients (a) which is operated in connection with a hospital, or (b) in which patient care is under the professional supervision of persons licensed to practice medicine or surgery within the State, or in the case of dental diagnosis or treatment, under the professional supervision of persons licensed to practice dentistry within the State.

    • 7.  Rehabilitation Facilities:

      The term "rehabilitation facility" means a facility which is operated for the rehabilitation of disabled persons through an integrated program of: (a) medical evaluation services, and (b) psychological, social or vocational evaluation services, under competent professional supervision, and in the case of which, (c) the major portion of the required evaluation and services is furnished within the facility, and (d) either (1) the facility is operated in connection with a hospital, or (2) all medical and related health services are prescribed by, or are under the general direction of, persons licensed to practice medicine or surgery in the State of South Carolina.

    • 8.  Privately Owned Educational Institutional Infirmary:

      The term "privately owned educational institutional infirmary" within the scope of the Licensing Standards is defined as a privately owned college infirmary.

  • E.  Designee:

    A physician, dentist, osteopath or podiatrist, who has staff privileges, selected by a prescriber to sign verbal orders for medication or treatment in the prescriber's absence.

  • F.  Existing Facility:

    An "existing facility" is one which was in operation and/or one which began the construction or renovation of a building, for the purpose of operating the facility, prior to the adoption of these Standards. The Licensing Standards governing new facilities apply if and when an existing facility is not continuously operated and licensed under these Standards.

  • G.  New Facilities:

    A "new facility" is one which began operation and/or one which began construction or renovation of a building for the purpose of operating the facility after the adoption of these Standards.

  • H.  Attic:

    The term "attic" when used in these Standards shall mean the space between the finished ceiling of the top habitable story and the roof sheathing or decking.

  • I.  Basement:

    The term "basement" shall mean that portion of the building having less than half its clear height above the average grade of the adjoining ground.

  • J.  Story:

    The term "story" shall mean that portion of a building included between the upper surface of any floor and the under surface of the floor or roof next above. For the purpose of these Standards, this definition does not apply to basements.

  • K.  Multii-Story:

    For the purposes of these Standards, the term "multi-story" shall mean more than one story.

  • L.  First Floor:

    The term "first floor" shall be that story which is of such height above grade that it does not come within the definition of a basement or shall be that story located immediately above a basement.

  • M.  Exit:

    "Exit" is that portion of a means of egress which is separated from the area of the building from which escape is to be made by walls, floors, doors or other means which provide the protected path necessary for the occupants to proceed with safety to the exterior of the building.

  • N.  Fire Resistive Rating:

    The term "fire resistive rating" shall mean time in hours or fractions thereof that materials or their assemblies will resist fire exposure as determined by fire tests conducted in compliance with recognized standards, i.e., ASTM and NFPA.

  • O.  Automatic Sprinkler System:

    The term "automatic sprinkler system" shall mean an arrangement of piping and sprinklers designed to operate automatically by the heat of fire and to discharge water upon the fire.

Section 206. REPORTS

  • Section 206.1Fire Report:

    A complete written report shall be prepared and promptly submitted to the Department for every fire regardless of size or damage that occurs in the facility.

  • Section 206.2Accident and/or Incident Report:

    A record of each accident and/or incident occurring in the facility, including medication errors and adverse drug reactions, shall be retained. Incidents resulting in death or serious injury, e.g., broken limb, shall be reported, in writing, to the Division of Health Licensing within ten days of the occurrence.

  • Section 206.3Joint Annual Report:

    The Department requires each health care facility to annually complete a questionnaire named “Joint Annual Report” and return this report within the time period as specified in the report's accompanying cover letter.

Section 404. NURSING PROCEDURES

  • Section 404.3Nursing Procedures, Administration of Medications:
    • A. Drugs shall be administered only upon the order of a physician, dentist, osteopath or podiatrist who has been granted medical staff privileges. Such orders shall be properly recorded in the medical record and signed by the prescriber or his designee.
    • B. Verbal and telephone orders shall be given only to a licensed nurse and immediately recorded, dated and signed. This restriction shall not be construed to prohibit the issuance and acceptance of verbal orders in other specialized departments or services as authorized in the medical staff by-laws, e.g., orders pertaining to respiratory therapy modalities and medications administered therewith may be given to respiratory therapy personnel, radiology instructions to radiology technicians, and physical therapy orders to physical therapists. All verbal and telephone orders shall be countersigned by the prescriber or his designee within 48 hours.
    • C. All medications shall be administered by a:
      • 1. medical doctor,
      • 2. osteopath,
      • 3. dentist,
      • 4. podiatrist,
      • 5. registered professional nurse,
      • 6. licensed practical nurse,
      • 7. registered pharmacist,
      • 8. respiratory therapy specialist (in a department under medical direction) for medications administered via respiratory therapy devices,
      • 9. student nurse under the direct supervision of a registered professional nurse who is the student's instructor, or
      • 10. respiratory therapy student under the direct supervision of a Respiratory Therapy Specialist who is the student's instructor.
    • The appropriate committee of the medical staff may, of course, establish more restrictive criteria regarding specific procedures, medications, groups and individuals.
    • D. Self administration of medications by patients may be permitted only when specifically ordered by the physician in writing.
    • E. Medication errors and adverse drug reactions shall be reported immediately to the prescriber, supervising nurse and pharmacist and recorded in the patient's medical record.
    • F. Medications for each patient must be kept in the original container; transferring between containers is forbidden.

61-17. Standards for Licensing Nursing Homes.

A. Definitions and Interpretations

  • (1) Definitions
    For the purpose of these Standards the following definitions shall apply:
    • (a) Accidents/Incidents shall be considered as, but not limited to, medication errors, adverse drug reactions, missing residents, and verbal or written threats to harm the health and welfare of the residents.
    • (b) Attic means the space between the finished ceiling of the top habitable story and the roof sheathing or decking.
    • (c) Automatic Sprinkler System means an arrangement of piping and sprinklers designed to operate automatically by the heat of fire and to discharge water upon the fire.
    • (d) Basement means that portion of the building having less than half its clear height above the average grade of the adjoining ground.
    • (e) Department means South Carolina Department of Health and Environmental Control.
    • (f) Designee means a physician, dentist, osteopath or podiatrist selected by a prescriber to sign orders for medication or treatment in the prescriber's absence.
    • (g) Existing Facility means one which was in operation and/or which began the construction or renovation of a building with approved plans for the purpose of operating the facility prior to adoption of these Standards. The Licensing Standards governing “new facilities” apply if and when an “existing facility” is not continuously operated and licensed under these Standards or is an existing building going to be licensed for the first time.
    • (h) Exit means that portion of a means of egress which is separated from the area of the building from which escape is to be made, by walls, floors, doors or other means which provide the protected path necessary for the occupants to proceed with safety to the exterior of the building.
    • (i) Fire-Resistive Rating means the time in hours or fractions thereof that materials and their assemblies will resist fire exposure as determined by fire tests conducted in compliance with recognized standards, i.e., NFPA, ASTM.
    • (j) First Floor means that story which is of such height above grade that it does not come within the definition of a basement or that story located immediately above a basement.
    • (k) Institutional Nursing Home means a nursing home (established within the jurisdiction of a larger nonmedical institution) which maintains and operates organized facilities and services to accommodate only students, residents or inmates of the institution.
    • (l) Licensee means the legal entity with whom rests the ultimate responsibility for maintaining approved Standards for the facility.
    • (m) New Facility means one which began operation and/or one which began construction or renovation of a building for the purpose of operating the facility after adoption of these Standards.
    • (n) Nursing home means a facility with an organized nursing staff to maintain and operate organized facilities and services to accommodate two or more unrelated persons over a period exceeding twenty-four hours which is operated either in connection with a hospital or as a freestanding facility for the express or implied purpose of providing nursing care for persons who are not in need of hospital care.
    • (o) Nursing Station means an area of a facility which is the central focus of resident management, nursing function, and service for a nursing unit. This area may also be used for administrative functions by other disciplines which provide services to the residents of the facility. A nurses' station shall serve not more than 44 beds. (See Section Y.(7) also.)
    • (p) Resident means any person residing in a nursing home.
    • (q) Story means that portion of a building included between the upper surface of any floor and the under surface of the floor or roof next above. For the purpose of these Standards, this definition does not apply to basements.
  • (2) Interpretations
    • (a) License required for facility operation: No facility shall be established, conducted or maintained in the State without first obtaining a license therefor in the manner herein prescribed. (I)
    • (b) A license is issued pursuant to the provisions of Section 44-7-250 et seq. of the South Carolina Code of Laws of 1976, as amended, and the standards promulgated thereunder. The license certificate shall be posted in a conspicuous place in a public lobby, waiting room, or other area immediately accessible to public view. The issuance of a license does not guarantee adequacy of individual care, treatment, personal safety, fire safety or the well-being of any occupant of a facility. A license is not assignable or transferable and is subject to revocation by the Department for failure to comply with the laws of the State of South Carolina.
    • (c) Effective Date and Term of License: A license shall be effective for a 12-month period following the date of issue and shall expire one year following such date; however, a facility that has not been inspected during that year may continue to operate under its existing license until an inspection is made.
    • (d) Separate Licenses: Separate licenses are required for facilities not maintained on the same premises. Separate licenses may be issued for facilities maintained in separate buildings on the same premises. Each building of a licensed facility must be staffed in accordance with Section E.
    • (e) Licensing Fees: Each applicant shall pay an annual license fee prior to issuance of the license. The fee shall be $50.00 for the first 10 beds and $.25 per bed over 10 through December 31, 1991. For licenses issued beginning January 1, 1992, the fee shall be $10.00 per bed.
    • (f) Facilities Exempt from these Standards:
      • (1) Any facility which is owned and operated by the federal government.
      • (2) Facilities providing domiciliary care and personal care services such as room, board, laundry and personal services incidental to the activities of daily living which do not require the technical skill, services or supervision of a licensed nurse.
    • (g) Inspections: All facilities to which these requirements apply shall be subject to inspection at any time without prior notice by properly identified personnel of the Department. Medical records, statistical reports, accident/incident reports, and other documents required by the regulations shall be maintained and available for review during an inspection.
    • (h) Initial License: A new facility, or one that has not been continuously licensed under these or prior Standards, shall not admit residents until it has been issued an initial license. An initial license will not be issued until the applicant has demonstrated to the satisfaction of the Department that the facility is in compliance with the Licensing Standards set forth hereunder.
    • (i) Noncompliance: When noncompliances of the Licensing Standards are detected by means of inspection or investigation, the applicant or licensee will be notified of the violations and at the same time requested to provide information as to when such items will be corrected.
    • (j) Exceptions to Licensing Standards: The Department reserves the right to make exceptions to these Standards where it is determined that the health and welfare of the community requires the services of the facility and that the exception, as granted, will have no significant impact on the safety, security or welfare of the facility's occupants.
    • (k) Change of License: A facility shall request issue of an amended license, by application to the Department, prior to any of the following circumstances: (II)
      • (1) Change of ownership by purchase or lease.
      • (2) Change of facility's name or address.
      • (3) Addition or replacement of beds
      • (4) Reduction of number of licensed beds.
  • (3) Types of Licenses
    Each nursing home license will specify the number and type bed(s) authorized for each facility as indicated below.
    • (a) nursing home;
    • (b) institutional nursing home;
  • (4) Penalties
    As provided in Section 44-7-320 of the South Carolina Code of Laws of 1976, as amended, the department may deny, suspend, or revoke licenses or assess a monetary penalty for violations of provisions of law or departmental regulations. The department shall exercise discretion in arriving at its decision to take any of these actions. The department will consider the following factors: specific conditions and their impact or potential impact on health, safety or welfare; efforts by the facility to correct; overall conditions; history of compliance; any other pertinent conditions. The notations, “(I)” or “(II),” placed within sections of this regulation, indicate those standards whose failure to meet are considered Class I or II violations, respectively. Failure to meet standards not so annotated are considered Class III violations. If a decision is made to assess monetary penalties, the following schedule will be used as a guide to determine the dollar amount.

    Frequency of violation of standard within 24-month Period
    vs. Monetary Penalty Ranges

    24-month
    period
    Class I Class II Class III
    1st $ 200-1000 $ 100-500 $ 0
    2nd $ 200-2,000 $ 200-1,000 $ 100-500
    3rd $ 1000-5000 $ 500-2000 $ 200-1000
    4th $ 5,000 $ 1,000-5,000 $ 500-2,000
    5th $ 5,000 $ 5,000 $ 1,000-5,000
    6th $ 5,000 $ 5,000 $ 5,000
    • (a) Class I violations are those which the Department determines present an imminent danger to the residents of the facility or a substantial probability that death or serious harm could result therefrom. A physical condition, one or more practices, means, methods or operations in use in a facility may constitute such a violation. The condition or practice constituting a Class I violation shall be abated or eliminated immediately unless a fixed period of time, as stipulated by the Department, is required for correction. Each day such violation shall exist after expiration of said time shall be considered a subsequent violation.
    • (b) Class II violations are those which the Department determines have a direct or immediate relationship to the health, safety or security of the facility's residents other than Class I violations. The citation of a Class II violation shall specify the time within which the violation is required to be corrected. Each day such violation shall exist after expiration of said time shall be considered a subsequent violation.
    • (c) Class III violations are those which are not classified as serious in these regulations or those which are against the best practices as interpreted by the Department. The citation of a Class III violation shall specify the time within which the violation is required to be corrected. Each day such violation shall exist after expiration of said time shall be considered a subsequent violation.
    • (d) Violations of Section 44-7-320.A (2) and (4) [See Note] of the South Carolina Code of Laws of 1976, as amended, quoted below, are considered Class I violations: “(2) permitting, aiding, or abetting the commission of any unlawful act relating to the securing of a Certificate of Need or the establishment, maintenance, or operation of a facility requiring certification of need or licensure under this article;” “(4) refusing to admit and treat alcoholic and substance abusers, the mentally ill, or mentally retarded, whose admission or treatment has been prescribed by a physician who is a member of the facility's medical staff; or discriminating against alcoholics, the mentally ill, or mentally retarded solely because of the alcoholism, mental illness, or mental retardation.”
  • [Note: This reference, as printed in the State Register, is incorrect. The correct reference is 44-7-320(A)(1)(b) and (A)(1)(d)]

61-17. Standards for Licensing Nursing Homes.

Section 61-17B. Management. – Section 7. Reports and Records

  • (7) Reports and Records:
    • (a) Accidents/Incident Reports: A record of each accident and/or incident, involving residents, staff or visitors, occurring in the facility or on facility grounds shall be retained. Accidents/Incidents resulting in death or serious injury shall be reported in writing to the Division of Health Licensing within 10 days of the occurrence.
    • (b) Serious injuries shall be considered as, but not limited to fractures of major limbs or joints, severe burns, severe lacerations, severe hematomas, and suspected abuse.
    • (c) All accidents/incidents shall be reviewed, investigated if necessary and evaluated in accord with facility policy.
    • (d) Monthly Statistical Record: An accurate and up-to-date monthly statistical record shall be kept and must contain at least the following information: name; case number; age; sex; dates of admission, discharge or death; and days of care rendered during the month.
    • (e) The Department requires each health care facility to annually complete a questionnaire named "Joint Annual Report" and to return this report within the time period as specified in the report's accompanying cover letter.
    • (f) Fire Reports: A complete written report regarding every fire regardless of size or damage that occurs in the facility shall be prepared and promptly submitted to the Department within 10 days of the fire.
    • (g) Transfer Agreement: The facility shall have a written transfer agreement with one or more hospitals that provides reasonable assurance that transfer of residents will be made between the hospital and the nursing home whenever such transfer is deemed medically appropriate by the attending physician; or the nursing home shall have on file documented evidence that it has attempted in good faith to effect a transfer agreement. The transfer agreement shall be dated and signed by authorized officials of each facility that is a party to the agreement. The agreement shall provide reasonable assurance of mutual exchange of information necessary or useful in the care and treatment of individuals transferred between the facilities. The agreement shall be updated to assure that it continues in effect following changes in ownership or administration and at any other time as deemed advisable to maintain or further improve continuity of care. (II)

61-17. Standards for Licensing Nursing Homes.

Section 61-17F. Pharmaceutical Services.

  • (7) Conformance with Orders:
    • (a) Drugs shall be administered in accordance with orders of the attending physician, dentist or other person legally qualified to prescribe drugs or biologicals for human consumption. (Also see Sections E. [4] [b], G. [2] [c] and [d], and G. [3]). (I).
    • (b) Procedures shall be established to ensure that drugs are checked against the prescriber's orders and that the dose of drug administered to that resident is recorded in the resident's record by the person who administers the drug. Recording shall include the drug, dosage, mode of administration, date, time and identification of the person administering the drug(s). Initials are acceptable when they can be identified readily by signatures. (I)
  • (8) Medication Errors and Adverse Drug Reactions: Medication errors and adverse drug reactions shall be reported immediately to the prescriber and other personnel as required by facility policy, and an appropriate entry made in the resident's medical record. (I) (Refer to Section B. [7] [b].)

61-75. Standards for Licensing Day Care Facilities for Adults.
Section 61-75F. – Functional Safety

Section 61-75-F(3). (3) Emergency/Disaster Preparedness:

  • Section F.(3)-d.Incident and Accident Reports:
    • Incident and Accident Reports: A record of each accident or incident occurring in the facility shall be prepared immediately. Accidents resulting in serious injury or death shall be reported, in writing, to the Department within 10 days of the occurrence.

61-78. Standards for Licensing Hospices.
Section 61-78-600 – Reporting

Section 61-78-601. Incidents/Accidents (II).

  • Section 601Incidents / Accidents
    • A. A record of each incident and/or accident, including the use of mechanical/physical restraints and medication errors involving patients or staff members/volunteers in the hospice facility or on the hospice facility grounds, shall be prepared and retained.
      • 1. Incidents/Accidents resulting in unexpected death or inpatient hospitalization shall be reported via telephone to the next-of-kin or responsible party immediately and in writing to the Department's Division of Health Licensing within 10 days of the occurrence.
      • 2. Incidents/Accidents shall be considered as, but are not limited to: fractures of major limbs or joints, severe burns, severe lacerations, severe hematomas, and actual/suspected abuse/neglect/exploitation/mistreatment of patients.
    • B. Reports shall contain at a minimum: hospice name, patient age and sex, date of incident/accident, location, witness names, extent/type of injury and how treated, e.g., hospitalization, identified cause of incident/accident, internal investigation results if cause unknown, and the date of the report.
    • C. Incidents where patients have left the premises of the hospice facility without notice to staff members/volunteers of intent to leave and have not returned within 24 hours shall be reported to the next-of-kin or responsible party and to local law enforcement immediately. When patients who are cognitively impaired leave the premises without notice to staff members/volunteers, law enforcement, and next-of-kin shall be contacted immediately upon discovery of the patient's absence. The Division of Health Licensing shall be notified not later than 10 days of the occurrence.
    • D. Medication errors and adverse medication reactions shall be reported immediately to the next-of-kin or responsible party, prescriber, emergency contact, and other personnel as required by agency policy.
  • Section 602Patient Death
    The hospice shall have a written plan to be followed at the time of patient death. The plan must provide for:
    • A. Collection of data needed for the death certificate, as required by state law;
    • B. Recording time of death;
    • C. Pronouncement of death;
    • D. Notification of attending physician responsible for signing death certificate;
    • E. Notification of next-of-kin or responsible party;
    • F. Authorization and release of body to funeral home;
    • G. Notification to the Department of any death resulting from an injury, accident, or other possible unnatural causes.
  • Section 603Fire/Disasters (II)
    • A. The Division of Health Licensing shall be notified immediately via telephone or fax regarding any fire in the hospice facility followed by a complete written report, to include fire department reports, if any, to be submitted within a time-period determined by the hospice facility, but not to exceed 72 hours from the occurrence of the fire.
    • B. Any natural disaster or fire that jeopardizes the safety of any persons in the hospice facility shall be reported to the Division of Health Licensing via telephone or fax immediately, with a complete written report which includes the fire report from the local fire department, if appropriate, submitted within a time-period as determined by the hospice facility, but not to exceed 72 hours.

61-84. Standards for Licensing Community Residential Care Facilities.
Section 61-84-600 – Reporting

Section 61-84-601. Incidents/Accidents (II).

  • Section 601Incidents / Accidents
    • A. A record of each incident and/or accident, including usage of mechanical/physical restraints, involving residents or staff members/volunteers, occurring in the facility or on the facility grounds, shall be retained.
      • 1. Incidents/accidents and/or serious medical conditions as defined below and any illness resulting in death or inpatient hospitalization shall be reported via telephone to the next-of-kin or responsible party immediately and the sponsoring agency at the earliest practicable hour, but not to exceed 12 hours of the occurrence, and in writing to the Department's Division of Health Licensing (DHL) within 10 days of the occurrence.
      • 2. Serious medical conditions shall be considered as, but not limited to: fractures of major limbs or joints, severe burns, severe lacerations, severe hematomas, and actual/suspected abuse/neglect/exploitation of residents.
    • B. Reports shall contain at a minimum: facility name, resident age and sex, date of incident/accident, location, witness names, extent/type of injury and how treated, (e.g., hospitalization), identified cause of incident/accident, internal investigation results if cause unknown, identity of other agencies notified of incident/accident and the date of the report.
    • C. Incidents where residents have left the premises without notice to staff members/volunteers of intent to leave and have not returned to the facility within 24 hours, shall be reported to the next-of-kin, sponsoring agency or any agency providing services to the resident and local law enforcement immediately. When residents who are cognitively impaired leave the premises without notice to staff members/volunteers, regardless of the time-period of departure, law enforcement, next-of-kin, and sponsoring agency shall be contacted immediately. DHL shall be notified not later than 10 days of the occurrence.
    • D. Medication errors and adverse medication reactions shall be reported immediately to the next-of-kin or responsible party, prescriber, supervising staff member, and administrator, and no later than 12 hours, as applicable to the sponsoring agency, and recorded in the resident record.
    • E. Changes in the resident's condition, to the extent that serious health concerns, e.g., heart attack, are evident, shall be reported immediately to the attending physician and the next-of-kin/responsible party, and no later than 12 hours afterwards to the administrator and the sponsor. (I)
  • Section 602. Fire/Disasters (II)
    • A. DHL shall be notified immediately via telephone or fax 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 72 hours from the occurrence of the fire.
    • B. Any natural disaster or fire, which requires displacement of the residents, or jeopardizes or potentially jeopardizes the safety of the residents, shall be reported to DHL via telephone/fax immediately, with a complete written report which includes the fire department report from the local fire department, if appropriate, submitted within a time-period as determined by the facility, but not to exceed 72 hours.

61-90. Minimum Standards for Licensing Chiropractic Facilities
Section 61-90-206 – Reports

Section 61-90-206. Reports

  • Section 206.1Fire Report:

    A complete written and signed report shall be prepared and promptly submitted to the Department of every fire regardless of size or damage that occurs in the facility.

  • Section 206.2Accident and/or Incident Report:

    A record of each accident and/or incident occurring in the facility shall be retained. Incidents resulting in death or serious injury, e.g., broken limb, shall be reported, in writing, to the Division of Health Licensing within ten days of the occurrence.

61-91. Ambulatory Surgical Centers
Section 61-91-302 – Violation Classifications.

  • Section 302Violations Classification

    Violations of standards in this regulation are classified as follows:

    • A. Class I violations are those that the Department determines to present an imminent danger to the health, safety, or well-being of the persons in the facility or a substantial probability that death or serious physical harm could result therefrom. A physical condition or one or more practices, means, methods or operations in use in a facility may constitute such a violation. The condition or practice constituting a Class I violation shall be abated or eliminated immediately unless a fixed period of time, as stipulated by the Department, is required for correction. Each day such violation exists after expiration of this time established by the Department may be considered a subsequent violation.
    • B. Class II violations are those, other than Class I violations, that the Department determines to have a negative impact on the health, safety, or well-being of persons in the facility. The citation of a Class II violation may specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time may be considered a subsequent violation.
    • C. Class III violations are those that are not classified as Class I or II in these regulations or those that are against the best practices as interpreted by the Department. The citation of a Class III violation may specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time may be considered a subsequent violation.
    • D. The notations "(I)" or "(II)", placed within sections of this regulation, indicate that those standards are considered Class I or II violations, if they are not met, respectively. Standards not so annotated are considered Class III violations.

61-91. Ambulatory Surgical Centers
Section 61-91-600 – Reporting

Section 61-91-601. Incidents/Accidents (II).

  • Section 601Incidents / Accidents
    • A. A record of each incident and/or accident, involving patients or staff members, occurring in the facility or on the facility grounds, shall be retained.
      • 1. Serious incidents/accidents and/or medical conditions as defined below and any illness resulting in death or inpatient hospitalization shall be reported via telephone to the next-of-kin or responsible party immediately and in writing to the Department's Division of Health Licensing within 10 days of the occurrence.
      • 2. Serious medical conditions shall be considered as, but not limited to: major permanent loss of function, hemolytic transfusion reaction involving administration of blood or blood products, surgery on the wrong patient or wrong body part, fractures of major limbs or joints, severe burns, lacerations, or hematomas, and actual or suspected abuse or mistreatment of patients.
    • B. Reports made to the Division of Health Licensing shall contain at a minimum: facility name, patient age and sex, date of incident/accident, location, extent/type of injury, and how treated, e.g., hospitalization.
    • C. Significant medication errors and significant adverse medication reactions that require intervention shall be reported immediately to the patient or next-of-kin or responsible party, prescriber, supervising staff member, and administrator. Significant medication errors and significant adverse medication reactions shall be considered as: unintended, undesirable, and unexpected effects of prescribed medications, or of medication errors that require discontinuing a medication or modifying the dose; require hospitalization; result in disability; require treatment with a prescription medication; result in cognitive deterioration or impairment; are life-threatening; or result in death.
    • D. Changes in the patient's condition, to the extent that serious health concerns are evident, e.g., heart attack, shall be reported immediately to the attending physician, the next-of-kin or responsible party, and the administrator. (I)
  • Section 602Fire/Disasters (II)
    • A. The Department's Office of Fire and Life Safety and the Division of Health Licensing shall be notified immediately via telephone 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 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's Division of Health Licensing via telephone or facsimile immediately, with a complete written report submitted within a time-period as determined by the facility, but not to exceed 72 hours.

61-93. Standards for Licensing Facilities that Treat Individuals for Psychoactive Substance Abuse or Dependence.
Section 61-93-600 – Reporting

Section 61-93-601. Incidents/Accidents (II).

  • Section 601Incidents / Accidents
    • A. A record of each accident and/or incident, including usage of physical restraints, involving clients or staff/volunteers, occurring in the facility or on the facility grounds shall be retained.
      • 1. Incidents/accidents and/or serious medical conditions as defined below and any illness resulting in death or inpatient hospitalization shall be reported via telephone to the next-of-kin or responsible person at the earliest practicable hour, but not to exceed 24 hours of the occurrence, and in writing to the Department's Division of Health Licensing (DHL) within 10 days of the occurrence.
      • 2. Serious medical conditions shall be considered as, but not limited to: fractures of major limbs or joints, severe burns, severe lacerations, severe hematomas, and actual/suspected abuse/neglect/exploitation of clients.
    • B. Reports shall contain at a minimum: facility/program name, client age and sex, date of incident/ accident, location, witness names, extent/type of injury and how treated, e.g., hospitalization, identified cause of incident/accident, internal investigation results if cause unknown, identity of other agencies notified of incident, and the date of the report.
    • C. Medication errors and adverse medication reactions shall be reported immediately, as applicable, to the prescriber, supervising nurse, pharmacist, and administrator and recorded in the client record.
    • D. In medical detoxification facilities only, incidents where clients have left the premises without notice to staff/volunteers of intent to leave and have not returned to the facility within 24 hours, shall be reported to DHL, next-of-kin, responsible person, and, if there is evidence that the client may be a danger to himself or others, local law enforcement.
    • E. In 24-hour facilities, changes in the client's condition to the extent that serious health concerns, e.g., heart attack, are evident, shall be reported immediately to the attending physician, and no later than 12 hours to next-of-kin/responsible person and administrator. (I)
    • F. In NTP facilities, premature or stillborn births to clients shall be reported in writing to DHL within 10 working days.
  • Section 602Fire/Disasters (II)
    • A. DHL shall be notified immediately via telephone or fax regarding any fire in the facility, and followed by a complete written report to include fire reports, if any, to be submitted within a time-period determined by the facility, but not to exceed 72 hours from the occurrence of the fire.
    • B. Any natural disaster or fire, that requires displacement of the clients, or jeopardizes or potentially jeopardizes the safety of the clients, shall be reported to DHL via telephone/fax immediately, followed by a complete written report which includes the fire report from the local fire department, if appropriate, submitted within a time-period as determined by the facility, but not to exceed 72 hours.

61-97. Standards for Licensing Renal Dialysis Facilities

Section 61-97-310. Incident and Accident Reports.

  • Section 310Incidents and Accident Reports

    A record of each accident or incident occurring in the facility, including medication errors and adverse drug reactions shall be prepared immediately. Accidents resulting in serious injury or death shall be reported, in writing, to the licensing agency within 10 days of the occurrence.

    Accidents and incidents that must be recorded include but are not limited to:

    • 1. Those leading to hospitalization;
    • 2. Those leading to death;
    • 3. Use of wrong dialyzer on patient;
    • 4. Blood spills of more than 75 ml.;
    • 5. Hemolytic transfusion reactions;
    • 6. Reactions to dialyzers.

    Note the policy memorandum regarding the position of DHEC regarding reportable incidents [PDF].

61-103. Residential Treatment Facilities for Children and Adolescents.

Section 61-103C. Governing Authority and Management.

  • Section 103 C. (4)Administrative Records
    • (4) Administrative Records: The following essential documents and references shall be on file in the administrative office of the facility:
      • (a) appropriate documents showing control and ownership;
      • (b) bylaws, policies and procedures of the governing authority;
      • (c) minutes of the governing authority meetings if applicable;
      • (d) minutes of the facility's professional and administrative staff meetings;
      • (e) a current copy of these regulations;
      • (f) reports of inspections, reviews, and corrective actions taken related to licensure;
      • (g) contracts and agreements related to licensure to which the facility is a party; and
      • (h) a record of each accident or incident occurring in the facility, including medication errors and drug reactions. Incidents resulting in hospitalization or death shall be reported in writing to the Department within 10 days.

61-108. Standards for Licensing Freestanding or Mobile Technology

Section 61-108-600. Reporting.

  • Section 601Incidents/Accidents (II)
    • A. A record of each accident and incident involving clients or technicians occurring in the facility shall be retained.
      • 1. Serious incidents/accidents and/or medical conditions as defined below and any illness resulting in death or inpatient hospitalization shall be reported via telephone to the next-of-kin or responsible party immediately and in writing to the Department's Division of Health Licensing within 10 days of the occurrence.
      • 2. Serious medical conditions shall be considered as, but not limited to: major permanent loss of function, hemolytic transfusion reaction involving administration of blood or blood products, a procedure on the wrong patient or wrong body part, fractures of major limbs or joints, severe burns, lacerations, or hematomas, and actual or suspected abuse or mistreatment of patients.
    • B. Reports made to the Division of Health Licensing shall contain at a minimum: facility name, patient age and sex, date of incident/accident, location, extent/type of injury, and means of treatment, e.g., hospitalization.
    • C. Significant medication errors and significant adverse medication reactions that require intervention shall be reported immediately to the patient or next-of-kin or responsible party, prescriber, supervising staff member, and administrator. Significant medication errors and significant adverse medication reactions include events that are unintended and undesirable, as well as unexpected effects of prescribed medications or of medication errors that:
      • 1. Require discontinuing a medication or modifying the dose;
      • 2. Require hospitalization;
      • 3. Result in disability;
      • 4. Require treatment with a prescription medication;
      • 5. Result in cognitive deterioration or impairment;
      • 6. Are life-threatening;
      • 7. Result in death.
    • D. Changes in the patient's condition, to the extent that serious health concerns are evident, e.g., heart attack, shall be reported immediately to the attending physician, the next-of-kin or responsible party, and the on-site manager. (I)
  • Section 602Fire/Disasters (II)

    The Department's Office of Fire and Life Safety and the Division of Health Licensing shall be notified immediately via telephone or facsimile regarding any fire occurring at the equipment location and followed by a complete written report to include fire department reports, if any, submitted within a time period determined by the policies and procedures, but not to exceed 10 days from the occurrence of the fire.

61-109. Standards for Licensing Body Piercing Facilities

Section 61-109-600. Incident and Accident Reports.

  • Section 601Incidents/Accidents (II)
    • A. A record of each accident and incident involving clients or technicians occurring in the facility shall be retained. Incidents or accidents resulting in serious medical conditions, e.g., lacerations, hematomas, actual or suspected abuse of clients by technicians, etc., in which the client is hospitalized, shall be reported via telephone to the next-of-kin or responsible person at the earliest practicable hour, but not to exceed 24 hours of the occurrence, and in writing to DHL within 10 days of the occurrence.
    • B. Reports shall contain at a minimum: facility name, technician name, client age and sex, date of incident or accident, location, witness names, identified cause of incident or accident, extent and type of injury and how treated, e.g., hospitalization, and the date of the report.
  • Section 602Fire/Disasters (II)
    • A. The facility permit holder shall notify DHL immediately via telephone or fax 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 72 hours from the occurrence of the fire.
    • B. Any natural disaster or fire that jeopardizes the safety of any persons in the facility shall be reported to DHL via telephone or fax immediately, with a complete written report which includes the fire report from the local fire department, if appropriate, submitted within a time-period as determined by the facility, but not to exceed 72 hours.
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