101. Definitions.

For the purpose of this regulation, the following definitions shall apply:

A.Abuse. Physical abuse or psychological abuse.

1. Physical Abuse. The act of intentionally inflicting or allowing to be inflicted physical injury on a resident by an act or failure to act. Physical abuse includes, but is not limited to, slapping, hitting, kicking, biting, choking, pinching, burning, actual or attempted sexual battery, use of medication outside the standards of reasonable medical practice for the purpose of controlling behavior, and unreasonable confinement. Physical abuse also includes the use of a restrictive or physically intrusive procedure to control behavior for the purpose of punishment except that a therapeutic procedure prescribed by a licensed physician or other legally authorized healthcare professional or that is part of a written ICP by a physician or another legally authorized healthcare professionals are not considered physical abuse. Physical abuse does not include altercations or acts of assault between residents.

2. Psychological Abuse. The deliberate use of any oral, written, or gestured language or depiction that includes disparaging or derogatory terms to a resident or within the resident’s hearing distance, regardless of the resident’s age, ability to comprehend, or disability, including threats or harassment or other forms of intimidating behavior causing fear, humiliation, degradation, agitation, confusion, or other forms of serious emotional distress.

B.Activities of Daily Living (ADL). Those personal functions performed by an individual in the course of a day that include, but are not limited to, walking; bathing; shaving; brushing teeth; combing hair; dressing; eating; getting in or getting out of bed; toileting; ambulating; doing laundry; cleaning room; managing money; shopping; using public transportation; making telephone calls; obtaining appointments; administration of medication; and other similar activities.

C.Administrator. The staff member designated by the licensee to have the authority and responsibility to manage the facility, is in charge of all functions and activities of the facility, and is appropriately licensed as a community residential care facility administrator by the S.C. State Board of Long Term Health Care Administrators.

D.Adult. A person 18 years of age or older.

E.Airborne Infection Isolation (AII). A room designed to maintain Airborne Infection Isolation, formerly called a negative pressure isolation room. An Airborne Infection Isolation room is a single-occupancy resident care room used to isolate persons with suspected or confirmed infectious tuberculosis (TB) disease. Environmental factors are controlled in Airborne Infection Isolation rooms to minimize the transmission of infectious agents that are usually spread from person-to- person by droplet nuclei associated with coughing or aerosolization of contaminated fluids. Airborne Infection Isolation rooms may provide negative pressure in the room (so that air flows under the door gap into the room), an air flow rate of six to twelve (6 to 12) air changes per hour (ACH), and direct exhaust of air from the room to the outside of the building or recirculation of air through a high efficiency particulate air (HEPA) filter.

F. Alzheimer’s Special Care Unit or Program. A facility or area within a facility providing a secure, special program or unit for residents with a diagnosis of probable Alzheimer’s disease and/or related dementia to prevent or limit access by a resident outside the designated or separated areas, and that advertises, markets, or otherwise promotes the facility as providing specialized care/services for persons with Alzheimer’s disease and/or related dementia or both.

G.Annual. A time period that requires an activity to be performed at least every twelve to thirteen (12 to 13) months.

H.Assessment. A procedure for determining the nature and extent of the problem(s) and needs of a resident/potential resident to ascertain if the facility can adequately address those problems, meet those needs, and to secure information for use in the development of the individual care plan. Included in the process are an evaluation of the physical, emotional, behavioral, social, spiritual, nutritional, recreational, and, when appropriate, vocational, educational, legal status/needs of a resident/potential resident. Consideration of each resident’s needs, strengths, and weaknesses shall be included in the assessment.

I. Authorized Healthcare Provider. An individual authorized by law and currently licensed in South Carolina to provide specific treatments, care, or services to residents, e.g., advanced practice registered nurse, physician assistant.

J. Blood Assay for Mycobacterium tuberculosis (BAMT). A general term to refer to in vitro diagnostic tests that assess for the presence of tuberculosis (TB) infection with M. tuberculosis. This term includes, but is not limited to, IFN-γ release assays (IGRA).

K.Boarding House. A business/entity which provides room and board to an individual(s) and which does not provide a degree of personal care to more than one individual.

L.Community Residential Care Facility (CRCF). A facility that offers room and board and which, unlike a boarding house, provides/coordinates a degree of personal care for a period of time in excess of 24 consecutive hours for two or more persons, 18 years old or older, not related to the licensee within the third degree of consanguinity. It is designed to accommodate residents’ changing needs and preferences, maximize residents’ dignity, autonomy, privacy, independence, and safety, and encourage family and community involvement. Included in this definition is any facility (other than a hospital), which offers or represents to the public that it offers a beneficial or protected environment specifically for individuals who have mental illness or disabilities. These facilities may be referred to as “assisted living” provided they meet the above definition of a community residential care facility.

M. Contact Investigation. Procedures that occur when a case of infectious TB is identified, including finding persons (contacts) exposed to the case, testing and evaluation of contacts to identify Latent TB Infection (LTBI) or TB disease, and treatment of these persons, as indicated.

N.Controlled Substance. Medication or other substances included in Schedule I, II, III, IV, and V of the Federal Controlled Substances Act and the South Carolina Controlled Substances Act.

O.Consultation. A visit by Department representative(s) who will provide information to the licensee with the goal of facilitating compliance with these regulations.

P. Department. The S.C. Department of Health and Environmental Control (DHEC).

Q.Designee. A staff member designated by the administrator to act on his/her behalf.

R.Direct Care Staff Member/Direct Care Volunteer. Those individuals who provide assistance with activities of daily living to residents.

S. Discharge. The point at which residents in a facility is terminated and the facility no longer maintains active responsibility for the care of the resident.

T.Dispensing Medication. The transferor possession of one (1) or more doses of a medication or device by a licensed pharmacist or individual as permitted by law, to the ultimate consumer or his or her agent pursuant to a lawful order of a practitioner in a suitable container appropriately labeled for subsequent
administration to, or use by a resident.

U.Exploitation. 1) Causing or requiring a resident to engage in an activity or labor that is improper, unlawful, or against the reasonable and rational wishes of a resident. Exploitation does not include requiring a resident to participate in an activity or labor that is a part of a written ICP or prescribed or authorized by the resident’s attending physician; 2) an improper, unlawful, or unauthorized use of the funds, assets, property, power of attorney, guardianship, or conservatorship of a resident by an individual for the profit or advantage of that individual or another individual; or 3) causing a resident to purchase goods or services for the profit or advantage of the seller or another individual through undue influence, harassment, duress,
force, coercion, or swindling by overreaching, cheating, or defrauding the resident through cunning arts or devices that delude the resident and cause him or her to lose money or other property.

V.Facility. A community residential care facility licensed by the Department.

W. Health Assessment. An evaluation of the health status of a staff member/volunteer by a physician, another authorized healthcare provider, or registered nurse, pursuant to written standing orders and/or protocol approved by a physician’s signature. The standing orders/protocol shall be reviewed annually by the
physician, with a copy maintained at the facility.

X.Incident. An unusual unexpected adverse event resulting in harm, injury, or death of staff or residents, accidents, e.g., medication errors, adverse medication reactions, elopement of a resident.

Y.Individual Care Plan (ICP). A documented regimen of appropriate care/services or written action plan prepared by the facility for each resident based on resident’s needs and preferences and which is to be implemented for the benefit of the resident.

Z.Inspection. A visit by a Department representative(s) for the purpose of determining compliance with this regulation.

AA. Investigation. A visit by a Department representative(s) to a licensed or unlicensed entity for the purpose of determining the validity of allegations received by the Department relating to this regulation.

BB. Latent TB Infection (LTBI). Infection with M. tuberculosis. Persons with Latent TB Infection carry the organism that causes TB but do not have TB disease, are asymptomatic, and are noninfectious. Such persons usually have a positive reaction to the tuberculin skin test and/or positive BAMT.

CC. Legend Drug.
1. A drug when, under Federal law, is required, prior to being dispensed or delivered, to be labeled with any of the following statements:
a. “Caution: Federal law prohibits dispensing without prescription”;
b. “Rx only” or;
2. A drug which is required by any applicable Federal or State law to be dispensed pursuant only to a
prescription drug order or is restricted to use by practitioners only;
3. Any drug products considered to be a public health threat, after notice and public hearing as
designated by the S.C. Board of Pharmacy; or
4. Any prescribed compounded prescription drug within the meaning of the Pharmacy Act.

DD. License. The authorization to operate a facility as defined in this regulation and as evidenced by current certificate issued by the Department to a facility.

EE. Licensed Nurse. A person to whom the S.C. Board of Nursing has issued a license as a registered the nurse or licensed practical nurse or an individual licensed as a registered nurse or licensed practical nurse who resides in another state that has been granted multi-state licensing privileges by the South Carolina Board of Nursing may practice nursing in any facility or activity licensed by the Department subject to the provisions and conditions as indicated in the Nurse Licensure Compact Act.

FF. Licensee. The individual, corporation, organization, or public entity that has received a license to provide care/services at a facility and with whom rests the ultimate responsibility for compliance with this regulation.

GG. Local Transportation. The maximum travel distance the facility shall undertake, at no cost to the resident, as addressed by the resident’s written agreement, to secure/provide health care for the resident. Local transportation shall be based on a reasonable assessment of the proximity of customary health care resources in the region, e.g., nearest hospitals, physicians and other health care providers, and appropriate consideration of resident preferences.

HH. Medication. A substance that has therapeutic effects, including, but not limited to, legend, nonlegend, herbal products, over-the-counter, nonprescription, vitamins, and nutritional supplements, etc.

II.Neglect. The failure or omission of a direct care staff member or direct care volunteer to provide the care, goods, or services necessary to maintain the health or safety of a resident including, but not limited to, food, clothing, medicine, shelter, supervision, and medical services. Failure to provide adequate supervision resulting in harm to residents, including altercations or acts of assault between residents, may constitute neglect. Neglect may be repeated conduct or a single incident that has produced or could result in physical or psychological harm or a substantial risk of death. Noncompliance with regulatory standards alone does not constitute neglect.

JJ. Nonlegend Drug. A drug that may be sold without a prescription and which is labeled for use b the consumer in accordance with the requirements of the laws of this State and the Federal government.

KK. Nursing Home. A facility with organized nursing staff to maintain and operate organized facilities and services to accommodate two (2) or more unrelated individuals over a period exceeding twenty-four (24) hours which is operated either in connection with a hospital or as a freestanding facility for the express or implied purpose of providing intermediate or skilled care for persons who are not in need of hospital care.

LL. Peak Hours. Those hours from 7 a.m. to 7 p.m., or as otherwise approved in writing by the Department.

MM. Personal Care. The provision by the staff members/direct care volunteers of the facility of one or more of the following services, as required by the individual care plan or orders by the physician or other an authorized healthcare provider or as reasonably requested by the resident, including:
1. Assisting and/or directing the resident with activities of daily living;
2. Being aware of the resident’s general whereabouts, although the resident may travel independently in the community;
3. Monitoring of the activities of the resident while on the premises of the residence to ensure his/her health, safety, and well-being.

NN. Personal Monies. All monies are available to the resident for his/her personal use, including family donations.

OO. Physical Examination. An examination of a resident by a physician or other authorized healthcare provider addresses those issues identified in Section 1101 of this regulation.

PP. Physician. An individual currently licensed to practice medicine by the S.C. Board of Medical Examiners.

QQ. Physician Assistant. An individual currently licensed as such by the S.C. Board of Medical Examiners.

RR. Private Sitter. A private contractor not associated with or employed by the facility with whom the resident or the resident’s responsible party contracts to provide sitter or companion services.

SS. Quality Improvement Program. The process used by a facility to examine its methods and practices of providing care/services, identify the ways to improve its performance, and take actions that result in a higher quality of care/services for the facility’s residents.

TT. Quarterly. A time period that requires an activity to be performed at least four (4) times a year within intervals ranging from eighty-one to ninety-nine (81 to 99) days.

UU. Related/Relative. This degree of kinship is considered “within the third degree of consanguinity,”
e.g., a spouse, son, daughter, sister, brother, parent, aunt, uncle, niece, nephew, grandparent, great-grandparent, grandchild, or great-grandchild.

VV. Repeat Violation. The recurrence of a violation cited under the same section of the regulation within a 36-month period. The time-period determinant of repeat violation status is applicable in instances when there are ownership changes.

WW. Resident. Any individual, other than staff members/volunteers or owner and their family members, who resides in a facility.

XX. Resident Room. An area enclosed by four ceiling-high walls that can house one or more residents of the facility.

YY. Respite Care. Short-term care (a period of six weeks or less) provided to an individual to relieve the
family members or other persons caring for the individual, but for not less than twenty- four (24) hours.

ZZ. Responsible Party. A person who is authorized by law to make decisions on behalf of a resident, to include, but not be limited to, a court-appointed guardian (or legal guardian as referred to in the Resident’s Bill of Rights) or conservator, or health care or other durable power of attorney.

AAA. Restraint. Any means by which movement of a resident is inhibited, i.e., physical, mechanical, chemical. In addition, devices shall be considered a restraint if a resident is unable to easily release from the device.

BBB. Revocation of License. An action by the Department to cancel or annul a facility license by recalling, withdrawing, or rescinding its authority to operate.

CCC. Risk Assessment. An initial and ongoing evaluation of the risk for transmission of M. tuberculosis in a particular healthcare setting. To perform a risk assessment, the following factors shall be considered: the community rate of TB, the number of TB patients encountered in the setting, and the speed with which patients with TB disease are suspected, isolated, and evaluated. The TB risk assessment determines the types of administrative and environmental controls and respiratory protection needed for a setting.

DDD. Self-Administration. A procedure by which any medication is taken orally, injected, inserted, or topically or otherwise administered by a resident to himself or herself without prompting. The procedure is performed without assistance and includes removing an individual dose from a previously dispensed and labeled container (including a unit dose container), verifying it with the directions on the label, taking it orally, injecting, inserting, or applying topically or otherwise administering the medication.

EEE. Sponsor. The public agency or individual involved in one or more of the following: protective custody authorized by law, placement, providing ongoing services, or assisting in providing services to a resident(s) consistent with the wishes of the resident or responsible party or specific administrative or court order.

FFF. Staff Member. An adult, to include the administrator, who is a compensated employee of the facility on either a full or part-time basis.

GGG. Suspension of License. An action by the Department requiring a facility to cease operations for a
period of time or to require a facility to cease admitting residents, until such time as the Department rescinds
that restriction.

HHH. Volunteer. An adult who performs tasks at the facility at the direction of the administrator without compensation.

102. References.
A.The following Departmental publications are referenced in these regulations:
1. R.61-20, Communicable Diseases;
2. R.61-25, Retail Food Establishments;
3. R.61-51, Public Swimming Pools;
4. R.61-58, State Primary Drinking Water Regulations;
5. R.61-67, Standards for Wastewater Facility Construction;
7 | Regulation 61-84
6. R.61-105, South Carolina Infectious Waste Management Regulations;
B.The following non-Departmental publications are referenced within this regulation:
1. Underwriters Laboratories–Fire Resistance Directory;
2. Underwriters Laboratories–Building Materials List;
3. Occupational Safety and Health Act of 1970 (OSHA);
4. Omnibus Adult Protection Act;
5. Alzheimer’s Special Care Disclosure Act;
6. Food and Nutrition Board of the National Research Council, National Academy of Sciences;
7. National Sanitation Federation;
8. Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings,
December 30, 2005;
9. U.S. Pharmacopoeia.

103. License Requirements (II).

A.License. No person, private or public organization, political subdivision, or governmental agency shall establish, operate, maintain, or represent itself (advertise/market) as a community residential care facility in S.C. without first obtaining a license from the Department. The facility shall not admit residents prior to the effective date of the license. When it has been determined by the Department that room, board, and a degree of personal care to two or more adults unrelated to the owner is being provided at a location, and the owner has not been issued a license from the Department to provide such care, the owner shall cease operation immediately and ensure the safety, health, and well-being of the occupants. Current/previous violations of the S.C. Code and/or Department regulations may jeopardize the issuance of a license for the facility or the licensing of any other facility, or addition to an existing facility that is owned/operated by the licensee. The facility shall provide only the care/services it is licensed to provide pursuant to the definitions in Sections 101.L and 101.LL of this regulation. (I)

B.Compliance. An initial license shall not be issued to a proposed facility that has not been previously and continuously licensed under Department regulations until the licensee has demonstrated to the Department that the proposed facility is in substantial compliance with the licensing standards. In the event a licensee who already has a facility/activity licensed by the Department makes an application for another facility or increase in licensed bed capacity, the currently licensed facility/activity shall be in substantial compliance with the applicable standards prior to the Department issuing a license to the proposed facility or amended license to the existing facility. A copy of the licensing standards shall be maintained at the facility and accessible to all staff members/volunteers. Facilities shall comply with applicable local, state, and Federal laws, codes, and regulations.

C.Compliance with Structural Standards. Facilities licensed at the time of promulgation of this regulation shall be allowed to continue utilizing the previously-licensed structure without modification.

D.Licensed Bed Capacity. No facility that has been authorized to provide a set number of licensed beds, as identified on the face of the license, shall exceed the bed capacity. No facility shall establish new care/services or occupy additional beds or renovated space without first obtaining authorization from the Department. Beds for use of staff members/volunteers are not included in the licensed bed capacity number, provided such beds and locations are so identified and used exclusively by staff members/volunteers. (I)

E.Persons Received in Excess of Licensed Bed Capacity. No facility shall receive for care or services persons in excess of the licensed bed capacity, except in cases of justified emergencies. (I)

F. Living Quarters for Staff Members. In addition to residents, only staff members, volunteers, or owners of the facility and members of the owner’s immediate family may reside in facilities licensed under this regulation. Resident rooms shall not be utilized by any individuals other than facility residents, nor shall bedrooms of staff members/family members of the owner or the licensee be utilized by residents. Staff members/family members of the owner or licensee/volunteers shall not use resident living rooms, recreational areas or dining rooms unless they are on duty.

G.Issuance and Terms of License.
1. A license is issued by the Department and shall be posted in a conspicuous place in a public area within the facility.
2. The issuance of a license does not guarantee the adequacy of individual care, services, personal safety, fire safety, or the well-being of any resident or occupant of a facility.
3. A license is not assignable or transferable and is subject to revocation at any time by the Department
for the licensee’s failure to comply with the laws and regulations of this State.
4. A license shall be effective for a specified facility, at a specific location(s), for a specified period following the date of issue as determined by the Department. A license shall remain in effect until the Department notifies the licensee of a change in that status.
5. Facilities owned by the same entity but which are not located on the same adjoining or contiguous property shall be separately licensed. Roads or local streets, except limited access, e.g., interstate highways, shall not be considered as dividing otherwise adjoining or contiguous property. Facilities owned by the same entity, separate licenses are not required for separate buildings on the same or adjoining grounds where a single level or type of care is provided.
6. Multiple types of facilities on the same premises shall be licensed separately even though owned by the same entity.
7. Facilities may furnish respite care provided compliance with the standards of this regulation are met.

H.Facility Name. No proposed facility shall be named nor shall any existing facility have its name changed to the same or similar name as any other facility licensed in S.C. The Department shall determine if names are similar. If the facility is part of a “chain operation” it shall then have the geographic area in which it is located as part of its name.

I. Application. Applicants for a license shall submit to the Department a complete and accurate application on a form prescribed and furnished by the Department prior to initial licensing and periodically thereafter at intervals determined by the Department. The application includes both the applicant’s oath assuring that the contents of the application are accurate/true, and that the applicant will comply with this regulation. The application shall be signed by the owner(s) if an individual or partnership; in the case of a corporation, by two of its officers; or in the case of a governmental unit, by the head of the government department having jurisdiction. The application shall set forth the full name and address of the facility for
which the license is sought and of the owner in the event his/her address is different from that of the facility, the names of the persons in control of the facility. The Department may require additional information, including affirmative evidence of the applicant’s ability to comply with these regulations. Corporations or limited partnerships, limited liability companies, or any other organized business entity must be registered with the S.C. Office of the Secretary of State if required to do so by S.C. state law.

J. Licensing Fees. The annual license fee shall be $10.00 per licensed bed or $75.00 whichever is greater. Such fee shall be made payable by check or credit card to the Department and is not refundable. Fees for additional beds shall be prorated based upon the remaining months of the licensure year. If the application is denied or withdrawn, a portion of the fee may be refunded based upon the remaining months of the licensure year, or $75.00 whichever is lesser.

K.Late Fee. Failure to submit a renewal application or fee 30 days or more after the license expiration date may result in a late fee of $75.00 or 25% of the licensing fee amount, whichever is greater, in addition to the licensing fee. Continual failure to submit completed and accurate renewal applications and/or fees by the time period specified by the Department may result in an enforcement action.

L.License Renewal. For a license to be renewed, applicants shall file an application with the Department, pay a license fee, and shall not be undergoing enforcement actions by the Department. If the license renewal is delayed due to enforcement actions, the renewal license shall be issued only when the matter has been resolved satisfactorily by the Department, or when the adjudicatory process is completed, whichever is applicable.

M. Change of License.
1. A facility shall request the issuance of an amended license by application to the Department prior to
any of the following circumstances:
a. Change of ownership;
b. Change of licensed bed capacity;
c. Change of facility location from one geographic site to another.
2. Changes in facility name or address (as notified by the post office) shall be accomplished by
application or by a letter from the licensee.

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