South Carolina Code of Regulations
(Unannotated)
Current through State Register Volume 31, Issue 9, effective September 28, 2007.
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CHAPTER 61. - CONTINUED
DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL
61-80. Neonatal Screening For Inborn Metabolic Errors and Hemoglobinopathies.
Contents:
Section A. Purpose and Scope
Section B. Definitions
Section C. Testing
Section D. Collection of Specimen
Section E. Assurance of Diagnosis and Follow-Up
Section F. Storage of Specimen
Section G. Use of Stored Specimen
Section H. Forms
Section I. Enforcement Provision
Appendix A. Religious Objection Form: DHEC 1804, Newborn Screening Program, Parental Statement of Religious Objection
Appendix B. Information Release Form: DHEC 1878, Consent to Release Information Relative to Newborn Screening for Inborn Metabolic Errors and Hemoglobinopathies
Appendix C. Blood Sample Storage Options Form: DHEC 1812, Blood Sample Storage Options, Screening of Inborn Metabolic Errors and Hemoglobinopathies
Section A-Purpose and Scope
This regulation establishes rules implementing provisions of Section 44-37-30 of the South Carolina Code of Laws, 1976, as amended, regarding testing of newborn children for inborn metabolic errors and hemoglobinopathies. The Department of Health and Environmental Control has been given the legislative mandate to promulgate rules and regulations for screening for inborn metabolic errors and hemoglobinopathies and to ensure compliance with the screening of every child born in South Carolina. The responsibilities of the various agencies, institutions and persons involved in the screening process are defined. Procedures for storage and use of blood specimens and maintenance of confidentiality are included.
Section B-Definitions
1. Inborn Metabolic Errors--shall mean inborn errors of metabolism.
2. Hemoglobinopathy--shall mean a hematologic disorder or carrier state caused by alteration in the genetically determined molecular structure of hemoglobin which may result in overt anemia as well as clinical and other laboratory abnormalities.
3. Identifying Information--shall mean child's legal name, sex, race, birth date, time of birth, place of birth, birth weight, current weight, feeding type; parent's or legal guardian's complete name, complete address and telephone number; mother's Social Security Number.
4. Attending Physician--shall mean the physician who has entered into an agreement to provide care during and/or after delivery for the mother and/or her child. The physician listed on the laboratory form will be assumed to be the attending physician until notification to the contrary is received in accordance with Official Departmental Instructions.
5. Department--shall mean the South Carolina Department of Health and Environmental Control.
6. Laboratory--shall mean the South Carolina Department of Health and Environmental Control Bureau of Laboratories.
7. Bureau of Maternal and Child Health--shall mean an organizational unit of the South Carolina Department of Health and Environmental Control.
8. Official Departmental Instructions--shall mean detailed instructions approved by the Commissioner of the South Carolina Department of Health and Environmental Control or his designee under which the public and private health care providers, including hospitals, laboratories, clinics, physicians and their staffs screen all children born in South Carolina for designated Inborn Metabolic Errors and Hemoglobinopathies.
Section C-Testing
1. The Laboratory shall perform all screening tests for inborn metabolic errors and hemoglobinopathies using procedures compliant with the Clinical Laboratories Improvement Act of 1988, as amended, and approved by the Food and Drug Administration. If any result is abnormal, the appropriate test shall be repeated and confirmatory tests performed in accordance with Official Departmental Instructions.
2. The Laboratory, in conjunction with the Bureau of Maternal and Child Health, shall adopt standards for the quality assurance and interpretation of approved tests and for the collection of specimens.
3. Confirmation and repeat specimen testing are available from the Laboratory at no charge to patients suspected or diagnosed as having one of the diseases if the analysis is completed at the Laboratory.
4. Test results and identifying information are to be reported and recorded in accordance with Official Departmental Instructions.
Section D-Collection of Specimen
1. A specimen shall be collected from every child born in South Carolina for the purpose of screening for inborn metabolic errors and hemoglobinopathies.
2. Births in a Hospital
a. The attending physician is responsible for the collection of the specimen from every child born in the hospital in accordance with Official Departmental Instructions and is responsible for submission of the specimen to the Laboratory on the day of collection.
b. Under the direction of the attending physician, the specimen shall be collected under the most favorable conditions following the procedures specified in the Official Departmental Instructions. The brochure produced by the Department that explains newborn screening for inborn metabolic errors and hemoglobinopathies and blood specimen storage options shall be given to the parent or legal guardian of the child.
c. A specimen shall be collected from every child born in the hospital prior to release from the hospital (except when the parents object due to religious convictions) in accordance with the procedure specified in the Official Departmental Instructions. If the parent objects to the screening on the basis of religious convictions, the parent shall complete the procedure specified in the Official Departmental Instructions.
d. If for some reason the specimen is not collected at the hospital, the hospital shall then be responsible for notifying the Bureau of Maternal and Child Health as specified in the Official Departmental Instructions.
e. The Hospital shall review the patient record for each child born in the hospital no later than ten (10) days after delivery to ensure that a specimen was collected and submitted to the Laboratory.
3. Births Outside a Hospital
a. The attending physician is responsible for the collection of the specimen from every child in accordance with the Official Departmental Instructions and for submission of the specimen to the Laboratory on the day of collection.
b. Under the direction of the attending physician, the specimen shall be collected under the most favorable conditions following the procedure specified in the Official Departmental Instructions. The brochure produced by the Department that explains newborn screening for inborn metabolic errors and hemoglobinopathies and blood specimen storage options shall be given to the parent or legal guardian of the child.
c. If the parents object to the screening on the basis of religious convictions, the parents shall complete the procedure specified in the Official Departmental Instructions.
d. If for some reason the specimen is not collected within three (3) days of delivery by the attending physician, this physician shall notify the Bureau of Maternal and Child Health as specified in the Official Departmental Instructions.
e. If there is not an attending physician, then the person in attendance is responsible for the collection of the specimen. If there is no other person in attendance, then the parents or legal guardian shall notify the Health Department in the county in which the child resides within three (3) days of delivery so that a specimen may be collected.
Section E-Assurance of Diagnosis and Follow-up
1. Information obtained as a result of the tests conducted for screening for inborn metabolic errors and hemoglobinopathies is confidential and may be released only to the infant's physician or other staff acting under the direction of the physician, the child's parent or legal guardian, and the child when he/she is eighteen years of age or older.
2. Normal and abnormal test results will be forwarded by the Laboratory and/or Bureau of Maternal and Child Health to the attending physician who shall be responsible for informing the parents or legal guardian of test results.
3. If the child is not under the care of the attending physician, as specified in the Official Departmental Instructions, the person in attendance shall notify the Bureau of Maternal and Child Health. The Department will then notify the parents or legal guardian of the test results.
4. Upon notification that a specimen was insufficient or that it is necessary for a test to be repeated, the attending physician shall collect and submit a second specimen to the Laboratory in accordance with Official Departmental Instructions.
5. The attending physician shall initiate appropriate medical follow-up and diagnosis when abnormal test results occur. If that is not possible, the Bureau of Maternal and Child Health shall be notified as specified in the Official Departmental Instructions.
6. The attending physician shall notify the Bureau of Maternal and Child Health of all children born in South Carolina who are diagnosed as having inborn metabolic errors or hemoglobinopathies.
7. Appropriate genetic counseling should be offered to all families of children with abnormal test results as outlined in the Official Departmental Instructions.
Section F-Storage of Specimen
1. Hospital staff or other persons who collect blood specimens for the purpose of screening for inborn metabolic errors and hemoglobinopathies shall inform each child's parent or legal guardian of the blood specimen storage options.
2. Hospital staff or other persons who collect these blood specimens shall give the brochure produced by the Department that explains newborn screening for inborn metabolic errors and hemoglobinopathies to the parent or legal guardian as a means of informing them of the benefits of screening and blood specimen storage. Hospital staff or other persons who collect these blood specimens shall indicate that the brochure was given to the parent or legal guardian by documenting in the appropriate space on the Blood Sample Storage Options Form.
3. The Laboratory shall store all specimens at minus 20° Centigrade and may release specimens for purposes of confidential, anonymous scientific study unless prohibited by the parents, legal guardians, or children from whom the specimens were obtained when the children are eighteen years of age or older.
4. Hospital staff or other persons who collect these specimens shall ensure that the parent's or legal guardian's storage choice is documented on the Blood Sample Storage Options form if the parent or legal guardian does not agree to have their child's blood specimen stored and potentially released for confidential, anonymous scientific study. In these instances, the Laboratory shall maintain all such specimens based upon the storage option chosen by the parent or legal guardian as documented on the Blood Sample Storage Options form.
Section G-Use of Stored Specimen
1. Stored blood specimens may be released for the purposes of confidential, anonymous scientific study unless prohibited by the parent, legal guardian, or child from whom the specimen was obtained when he/she is eighteen years of age or older.
2. The Department's Institutional Review Board shall approve all scientific studies that use stored blood specimens before the specimens are released.
3. Blood specimens released for scientific study shall not contain information that may be used to determine the identity of the children from whom they were obtained by the person(s) to whom the specimens are released. The Department shall code the specimens before releasing them so that the Department can identify the children from whom the blood specimens were obtained if necessary.
4. If any such scientific study identifies genetic or other information that may benefit the children from whom the specimens were obtained, the Department may confidentially provide this information to the parents, legal guardians or children from whom the specimens were obtained when the children are eighteen years of age or older.
Section H-Forms
1. Religious Objection Form: The Religious Objection Form, Appendix A of this regulation, shall be completed if the parents refuse newborn screening for inborn metabolic errors and hemoglobinopathies for their child based upon religious convictions.
2. Information Release Form: The Information Release Form, Appendix B of this regulation, may be completed as needed for release of information regarding newborn screening for inborn metabolic errors and hemoglobinopathies to persons other than those specified elsewhere in this regulation.
3. Blood Sample Storage Options Form: The Blood Sample Storage Options Form, Appendix C of this regulation, shall be completed if the parents or legal guardians do not agree to have their child's specimen stored and potentially released for confidential, anonymous scientific study.
Section I-Enforcement Provision
1. Constitutionality
If any part or provision of these regulations is legally declared unconstitutional or if the application thereof to any persons or circumstances is held invalid, the validity and constitutionality of the remainder of these regulations shall not be affected thereby.
2. Penalties
Violation of these regulations shall be punishable in accordance with Section 44-37-30 of the Code of Laws of South Carolina, 1976, as amended.
APPENDIX A: Religious Objection Form: DHEC 1804, Newborn Screening Program, Parental Statement of Religious Objection
I am the parent or legal guardian of __________, a child born __________ in South Carolina. I request that my child not be tested by blood spot screening in order to detect silent, deadly metabolic diseases and hemoglobinopathies. I certify that this refusal is based on religious grounds. Religious grounds are the only permitted reason for refusal under South Carolina law, Section 44-37-30 (C).
I understand that my child may suffer brain damage, other bodily harm or death if a disease that can be detected by blood spot screening is not diagnosed. I understand that such harm can be lessened or prevented by early diagnosis and treatment. I understand that these diseases are usually silent, and may be present in a child that looks healthy. I understand that the blood spot screening test is the best way to detect these disorders early, and that testing is routinely done for every child. I understand that this testing is quick, easy and that the results are confidential. I understand that this testing has been the standard of care for all children born in South Carolina and the rest of the United States for many years.
I have been fully informed of, and fully understand, the possible devastating consequences to my child's health if blood spot screening is not done. I have been fully informed of, and fully understand the benefits of testing and blood specimen storage. I have been given the brochure produced by the South Carolina Department of Health and Environmental Control that describes the conditions for which testing is currently available and explains the benefits of testing and blood specimen storage. I also understand that my child would have been tested for these conditions except for my objection. I have been given the opportunity to ask questions concerning this testing and these conditions, and all of my questions have been fully answered to my satisfaction.
I release and hold harmless the South Carolina Department of Health and Environmental Control, the hospital or other facility at which the birth occurred, the person(s) responsible for the collection of the blood spots, and any other person or entity relying on this objection, for any injury, illness and/or consequences, including the death of my child, which may result to my child as the result of my refusal of blood spot screening.
Parent: __________ Date: __________
Witness: __________
NOTE TO PROVIDERS: This form is only necessary if the parent or legal guardian refuses testing for inborn metabolic errors and hemoglobinopathies.
APPENDIX B: Information Release Form: DHEC 1878, Authorization to Release Information Relative to Newborn Screening for Inborn Metabolic Errors and Hemoglobinopathies
Please check all boxes that apply.
[ ] A. I agree that information about __________, born __________, obtained as a result of tests conducted for screening for inborn metabolic errors and hemoglobinopathies may be released or exchanged with the following providers:
__________
__________
__________
[ ] B. In cases where this information is immediately needed for continuity of health care, I authorize the South Carolina Department of Health and Environmental Control to provide this information to the providers listed above by fax.
[ ] C. I authorize my signed form to be faxed to the providers listed above.
I understand that my confidentiality cannot be guaranteed when sending this information by fax. I understand that the copy of my signature below may be treated as an original signature.
I am the client, parent or legal guardian. I understand that I am responsible for this information if it is released to me and that my records are protected generally under state laws as well as statutes governing specific types of information and cannot be disclosed without my authorization. I also understand that I may revoke this authorization at any time except to the extent that action has been taken on it.
Signature: __________ Date: __________
Witness: __________ Date: __________
Revoked: __________ Date: __________
Some babies are born with diseases of the blood or body function. A baby with one of these diseases looks healthy. However, these diseases can cause mental retardation, abnormal growth, infections, or death. Some of these diseases can be found by early testing. This testing, called newborn screening, is important so that your baby is not harmed by one of these diseases. During newborn screening, a small sample of your baby's blood is taken from the heel. The blood is tested. The blood shows if your baby has any of the "newborn screening" diseases. If your baby has one of these diseases, your doctor can treat your baby.
DHEC can store your baby's blood sample for special study. Studies help DHEC find out new information about diseases. If a study finds something in your child's blood sample that can help your child, DHEC can confidentially notify you (or your child if he/she is 18 years or older).
APPENDIX C: Blood Sample Storage Options Form: DHEC 1812, Blood Sample Storage Options, Screening for Inborn Metabolic Errors and Hemoglobinopathies
Child's complete legal name: __________
Child's date of birth: __________
Parent or legal guardian's complete name: __________
Parent or legal guardian's complete address: __________
South Carolina law requires the Department of Health and Environmental Control to store your child's blood sample in a manner required by law. The blood sample is collected on a special piece of filter paper. This is called "newborn screening." The blood is tested to see if your child has one of the "newborn screening" diseases that can cause mental retardation, abnormal growth or even death. After the tests are done, the filter paper is stored in a freezer at the state laboratory. This storage is highly protected, and each sample is held under strict confidentiality. A child's blood sample can only be released for approved research, without any identifying information, to learn new information about diseases. The law allows you to choose one of the options below, if you do not want your child's blood sample handled this way. However, you are not required to check one of the boxes below.
[ ] I want my child's blood sample stored by the South Carolina Department of Health and Environmental Control, but I do not want my child's blood sample to be used for research.
[ ] I want my child's blood sample destroyed by the South Carolina Department of Health and Environmental Control two years after the date of testing.
[ ] I want my child's blood sample to be returned to me two years after the date of testing. I understand that it is my responsibility to notify the South Carolina Department of Health and Environmental Control, 2600 Bull Street, Columbia, SC, 29201, of address or name changes.
I have been given the brochure produced by the South Carolina Department of Health and Environmental Control that describes the conditions for which testing is currently available and explains the benefits of testing and blood sample storage.
Parent: __________ Date: __________
I have given the brochure produced by the South Carolina Department of Health and Environmental Control to the parent/legal guardian of the child named above.
Name: __________ Date: __________
DHEC can store your baby's blood sample for special study. Studies help DHEC find out new information about diseases. If a study finds something in your child's blood sample that can help your child, DHEC can confidentially notify you (or your child if he/she is 18 years or older).
IF THIS FORM IS NOT SIGNED BY A PARENT/LEGAL GUARDIAN AND/OR NONE OF THE ABOVE BOXES ARE CHECKED, THE BLOOD SAMPLE WILL BE STORED AS REQUIRED BY SC CODE ANN. Section 44-37-30 AT -20 DEGREES CENTIGRADE AND MAY BE RELEASED ONLY FOR CONFIDENTIAL, ANONYMOUS SCIENTIFIC STUDY.
NOTE TO PROVIDERS: The parent or legal guardian is not required to sign this form. However, the person who gives the brochure that explains neonatal testing and blood sample storage to the parent or legal guardian must sign this form.
61-81. State Environmental Laboratory Certification Program.
Table of Contents
A. Authority
B. Purpose
C. Scope
D. Definitions
E. Parameters Requiring Certification
F. Certification Criteria
G. Certification
H. Loss of Certification
I. Recertification
J. Contract Laboratories
K. Appeals
L. Reciprocity
M. Effective Date
A. Authority
This Regulation implements Code Section 44-55-10 et seq., known as the South Carolina Safe Drinking Water Act; Code Section 48-1-10 et seq., known as the South Carolina Pollution Control Act; and Act #436 of 1978, known as the South Carolina Hazardous Waste Management Act.
B. Purpose
This Regulation provides the mechanism to assure the validity and quality of the data being generated for compliance with State regulations.
C. Scope
This Regulation applies to any laboratory performing analyses to determine the quality of air, drinking water, hazardous waste, solid waste, or wastewater; performing bioassays; or performing any other analyses related to environmental quality evaluations required by the Department or which will be officially submitted to the Department.
D. Definitions
(1) "Acceptable results" means a variance of less than plus or minus two (2) standard deviations from the true value of a performance audit sample, as utilized by the EPA for its evaluation of state laboratories, unless another variance for a specific parameter is announced prior to the analysis.
(2) "Board" means the governing body of the South Carolina Department of Health and Environmental Control.
(3) "Certificate" means that document issued by the State Environmental Laboratory Certification Officer showing those parameters for which a laboratory has received certification. The certificate remains the property of the Department and must be surrendered at the direction of the Department.
(4) "Certification" means a declaration by the Department that a laboratory has been evaluated under the State Environmental Laboratory Certification Program and found acceptable to analyze specified parameters.
(5) "CFR" means the Code of Federal Regulations.
(6) "Commissioner" means the duly constituted Commissioner of the Department or his authorized agent.
(7) "Department" means the South Carolina Department of Health and Environmental Control, including personnel thereof authorized and empowered by the Board to act on behalf of the Department or Board.
(8) "EPA" means the United States Environmental Protection Agency.
(9) "Evaluation" means a complete review of the quality control procedures, records keeping, reporting procedures, methodology, and analytical technique of a laboratory for specific parameters.
(10) "Interim approval" means a declaration by the Department that a laboratory has been evaluated under the State Environmental Laboratory Certification Program prior to the date of required certification and has been determined to be in substantial compliance with its requirements.
(11) "Laboratory" means any facility that performs analyses to determine the quality of air, drinking water, solid waste, hazardous waste, wastewater, performs bioassays; or any other analyses related to environmental quality evaluations required by the Department or which will be officially submitted to the Department.
(12) "Laboratory Director" means that person who has been given the responsibility by the laboratory's governing body (owners, directors, commissioners, councilmen, mayor, board members or who so ever occupies the status of proprietor) of supervising the operations of the laboratory and insuring the quality of data reported.
(13) "Performance audit sample" means a sample in which the concentrations of the constituents required for certification are known only to the State Environmental Laboratory Certification Officer and is used to determine analysts' proficiency.
(14) "State Environmental Laboratory Certification Officer" means that person designated by the Department who is responsible for the management of the State Environmental Laboratory Certification Program or his authorized delegate.
E. Parameters Requiring Certification
Certification of the laboratory is required before the Department will accept analytical data for any parameter required by the following:
(1) State Safe Drinking Water Act and Regulation
(2) State Pollution Control Act and Regulations
(3) State Solid Waste Management Regulation
(4) State Hazardous Waste Act and Regulations
F. Certification Criteria
It is the responsibility of the Department to inform laboratories certified under this regulation and those who have applied for certification of requirements in acceptable procedures, methodology, techniques, facilities, quality control, records keeping, and equipment, including any changes in those requirements. At no time shall requirements be imposed on a laboratory as a condition of certification that are not also imposed on the environmental laboratories of the Department.
G. Certification
It is the responsibility of the laboratory to initiate the application for certification under this Regulation. A pre-evaluation form must be filed with the Department, if requested by the State Environmental Laboratory Certification Officer. Upon review of the information provided, an on-site evaluation will be scheduled.
Each laboratory requesting certification will be evaluated by the State Environmental Laboratory Certification Officer who may be assisted by members of the Department's environmental laboratory staff upon his request. A written report will be filed with the State Environmental Laboratory Certification Officer within thirty (30) days following the evaluation. A copy of this report will be mailed to the Laboratory Director and the governing body.
(1) Issuance of Certification
Within seven (7) days of the receipt of the written report of the evaluation, the State Environmental Laboratory Certification Officer will notify the laboratory of his determination. If the adequacy of the laboratory capability and its proficiency have been established and in the absence of substantial deficiencies, certification will be issued to the laboratory for the evaluated parameters. The certificate will remain the property of the Department.
If there is an equipment deficiency, certification may be granted upon the receipt of a copy of a purchase order; or a repeat visit may be made to substantiate proper use of the item.
(2) Certification Continuance Between Evaluations
(a) In order to maintain certification for each parameter, the laboratory will analyze a minimum of one performance audit sample annually where technically feasible.
(b) In order to maintain certification, the laboratory will participate in split sampling with the Department Laboratory when required by the State Environmental Laboratory Certification Officer.
(3) Frequency of Certification
The laboratory will be evaluated for renewal of certification every three (3) years.
At any time during the certification period, at the discretion of the State Environmental Laboratory Certification Officer, an on site evaluation will be performed. For the convenience of the laboratory personnel and the evaluators, advanced notice of the inspection will be given.
(4) Laboratory Name
Any facility certified under this program will maintain only one name for the facility. This name will be used in all official correspondence with the Department.
H. Loss of Certification
(1) Total Laboratory Certification
Once certified, a laboratory's certificate will be withdrawn for knowingly and willfully falsifying data.
(2) Parameter Certification
Once certified, a laboratory will have its certification for a parameter withdrawn by failure to:
(a) Obtain acceptable results on a performance audit sample and a repeat audit sample.
(b) Comply with any part of Section F of this Regulation.
(c) Report results of performance audit samples within thirty (30) calendar days of receipt of samples.
I. Recertification
(1) A laboratory having lost certification for falsifying reports or misrepresenting data will not be eligible for recertification for a period of one (1) year, unless the responsible individual(s) is/are no longer associated with the laboratory.
(2) A laboratory having lost parameter certification as described in Section H(2) will have its certification reinstated after obtaining acceptable results on a performance audit sample.
J. Contract Laboratories
Any laboratory which sub-contracts analytical work to another must establish that the contracted laboratory has been certified by the Department for the appropriate parameters. Laboratory records must indicate who performs the analyses and the name of the contract laboratory must be included in these records.
K. Appeals
In the event a Laboratory Director disagrees with a decision affecting certification, an appeal, in accordance with Department Regulation #72, December 28, 1976, entitled "Procedures for Contested Cases", can be made to the Board.
L. Reciprocity
Laboratories, located in other states, which have been certified under an equivalent program, as determined by the State Environmental Laboratory Certification Officer, are eligible for certification under this Regulation. A notarized copy of the laboratory's certificate and a copy of the program, if requested, must be received by the Department prior to consideration for State certification.
Laboratories in states without an equivalent program may be evaluated under this Regulation upon payment of a fee, set by the Board, and expenses incurred by the Department evaluator(s).
M. Effective Date
This Regulation shall become effective January 1, 1981. Prior to the effective date, the Department may evaluate laboratories and make recommendations to assure compliance with the requirements of this Regulation, and issue an interim approval should the requirements be met before the effective date.
61-82. Proper Closeout of Wastewater Treatment Facilities.
Section I: Definitions
The definition of any work or phrase employed in Sections II, III, IV and V shall be the same as given in the S.C. Pollution Control Act. The following words or phrases, which are not defined in said law, shall be defined as follows:
1. Lagoon--Lagoon shall mean a relatively small body of water contained in an earthen basin of controlled shape which is designed for treatment or handling wastewater.
2. Package Plant--Package plant shall include prefabricated factory assembled units and other modular type units designed for the treatment of wastewater through activated sludge processes and modifications thereof. Although not generally considered a package plant, for the purpose of this Regulation, Imhoff tanks shall be considered a package plant.
3. Closeout--Closeout shall mean the cessation of waste treatment facility operations in accordance with the appropriate sections of this Regulation.
4. Abandonment--Abandonment shall mean the cessation of daily visits to the waste treatment facility by the certified operator in charge for the purpose of insuring proper operation and maintenance of a waste treatment facility.
5. "Should" and "Shall"--Should is permissive and shall is mandatory.
Section II: Proper closeout of lagoons
1. Lagoons shall be drained only after written permission has been obtained from DHEC and in accordance with one of the below procedures, (procedures in order of decreasing desirability):
a. Sewage from the lagoon may be pumped into the treatment facility or receiving system replacing the lagoon, provided that the rate is such that hydraulic and/or organic overloading and surging of the replacement system is prevented and provided that permission is obtained from the owner of the replacement system; or
b. If the above method is not possible, the lagoon may be drained into the receiving stream at a rate not exceeding the maximum design flow of the lagoon, provided that before draining, the lagoon is allowed to stabilize without additional inflowing sewage for a period not less than the design retention time of the lagoon.
c. If neither of the above methods is possible, an alternative method of closeout may be proposed for DHEC consideration.
2. In each of the above alternatives, the lagoon shall be drained from the surface of the lagoon to prevent accumulated solids on the bottom of the lagoon from being carried out of the lagoon.
3. After the treated sewage has been drained from the lagoon, solid accumulation on the bottom of the lagoon shall be allowed to dry. A disinfectant suitable for control of odors and vectors shall be applied to all remaining solids when determined necessary by DHEC. After drying, the solids should be mixed with soil and left on the bottom of the lagoon, be removed for disposal in an approved landfill, or disposed in some other approved method.
4. The lagoon may be filled with soil or may be allowed to remain bowlshaped, so as to be utilized for purposes other than waste handling, i.e., fish ponds, irrigation ponds, etc., provided that this practice does not violate local health and vector control regulations and DHEC approval of the close-out is obtained prior to any alternative use of the facility.
Section III: Proper closeout of package plants
Package plants shall be drained in accordance with one of the following procedures:
a. Sewage may be pumped into the treatment facility or receiving system replacing the package plant, provided that the rate is such that overloading of the replacement system is prevented and provided that permission is obtained from the owner of the replacement system; or
b. Sewage may be pumped into portable tanks for transfer and disposal in a sewer system, provided that permission is obtained from the owner of the receiving system.
Section IV: Proper closeout of waste treatment facilities not defined as lagoons and package plants.
Waste treatment facilities not defined as lagoons and package plants shall be closed out in accordance with guidelines issued by DHEC on an individual basis. These guidelines shall be designed to prevent health hazards and to promote safety in and around the abandoned sites.
Section V: Procedures applicable to all closeouts
1. A request for site inspection for closeout shall be made by the responsible official to DHEC.
2. A site inspection shall be conducted by DHEC and authorization to proceed with closeout granted by DHEC.
3. Monitoring as deemed necessary by DHEC to prevent water quality violations or nuisance conditions will be established on a case-by-case basis and carried out in accordance with DHEC guidance.
4. Upon completion of closeout the responsible party shall request an inspection by DHEC. The results of the inspection shall be reduced to writing and forwarded to the responsible official approving or disapproving the closeout. In cases of disapproval discrepancies shall be noted and a follow-up inspection scheduled.
5. Closeout will be considered accomplished only after approval in writing from DHEC.
6. Areas around all waste treatment facilities undergoing closeout shall remain secured until closeout has been accomplished. In an instance of package plant closeout, the plant shall remain secured until electrical power has been disconnected and the plant is removed from the premises and depressions resulting from the removal of the system filled.
Section VI: Penalties
Any person determined to be in violation of the procedures outlined in this Regulation or found to have abandoned a waste treatment facility without initiating and completing approved closeout of the waste treatment facility shall be subject to civil and criminal penalties prescribed in Section 48-1-320 and 48-1-330 of the South Carolina Code of Laws, 1976.
61-83. Transportation of Radioactive Waste Into or Within South Carolina.
Table of Contents
Section 1 Scope
Section 2 Definition
Section 3 Permits
Section 4 Shipper's Requirements
Section 5 Carrier's Requirements
Section 6 Disposal Facility Operator
Section 7 Penalties
Section 8 Severability Clause
Attachments:
Attachment I . . . . . Form RHA-200P "Application for Radioactive Waste Transport Permit"
Attachment II . . . . . Form RHA-PNC "Radioactive Waste Shipment Prior Notification and Manifest Form"
Attachment III . . . . . Form RHA-CT "Radioactive Waste Shipment Certification Form"
1. SCOPE
1.1 This regulation applies to any shipper, carrier or other person who transports radioactive waste into or within this State, to any persons involved in the generation of radioactive waste within this State, and to any shipper whose radioactive waste is transported into or within this State or is delivered, stored, or disposed of within this State.
1.2 All persons subject to the provisions of this regulation shall comply with all applicable provisions of the Nuclear Regulatory Commission Title 10 CFR Part 71 as revised January 1, 2006, (with the exception of sections 71.2, 71.6, 71.14(b), 71.19, 71.24, 71.31, 71.33, 71.35, 71.37, 71.38, 71.39, 71.41, 71.43, 71.45, 71.51, 71.52, 71.53, 71.55, 71.59, 71.61, 71.63, 71.64, 71.65, 71.71, 71.73, 71.74, 71.75, 71.77, 71.99 and 71.100), Regulation 61-83 of the 1976 Code of Laws of South Carolina, and any disposal facility radioactive material license requirements regarding the packaging, transportation, disposal, storage or delivery of radioactive materials.
2. DEFINITIONS
2.1 "Carrier" means any person transporting radioactive wastes into or within the State for storage, disposal or delivery.
2.2 "Department" means the Department of Health and Environmental Control including personnel authorized to act on behalf of the Department.
2.3 "Disposal facility" means any facility located within the State, which accepts radioactive waste for storage or disposal.
2.4 "Generation" means the act or process of producing radioactive wastes.
2.5 "Manifest" means the document used for identifying the quantity, composition, origin, and destination of radioactive waste during its transport to a disposal facility.
2.6 "Operator" means every person who drives or is in actual physical control of a vehicle transporting radioactive waste.
2.7 "Persons" means any individual, public or private corporation, political subdivision, government agency, municipality, industry, partnership or any other entity whatsoever.
2.8 "Permit" means an authorization issued by the Department to any person involved in the generation of radioactive waste, to transport such radioactive wastes or offer such waste for transport.
2.9 "Radioactive waste" means any and all equipment or materials, including irradiated nuclear reactor fuel, which are radioactive or have radioactive contamination and which are required pursuant to any governing laws, regulations, or licenses to be disposed of as radioactive waste.
2.10 "Radiological violation" means radioactive contamination or the emission of radiation in excess of applicable limits.
2.11 "Shipper" means any person, whether a resident of South Carolina or a non-resident:
2.11.1 who transfers radioactive waste to a carrier for transportation into or within the State; or,
2.11.2 who transports his own radioactive waste into or within the State; or,
2.11.3 who transfers radioactive waste to another person if such wastes are transported into or within the State.
2.12 "Transport" means the movement of radioactive wastes into or within South Carolina.
3. PERMITS
3.1 Before any shipper transports or causes to be transported radioactive waste into or within the State of South Carolina, he shall purchase an annual radioactive waste transport permit from the Department. An application for a permit shall be submitted on Department Form RHA-200P "Application for Radioactive Waste Transport Permit" together with the necessary fee to: Chief, Bureau of Radiological Health, S.C. Department of Health and Environmental Control, 2600 Bull Street, Columbia, South Carolina, 20201.
3.2 Before a permit shall be issued, the shipper must deposit and maintain with the Department a cash or corporate surety bond in the amount of Five Hundred Thousand Dollars ($500,000.00); or, provide to the Department satisfactory evidence of liability insurance.
3.2.1 For purposes of this regulation, liability insurance shall mean coverage of Five Hundred Thousand Dollars ($500,000.00) per occurrence and One Million Dollars ($1,000,000.00) aggregate, or as otherwise provided by State law.
3.2.2 Any insurance carried pursuant to Section 2210 of Title 42 of the United States Code and Part 140 of Title 10 of the Code of Federal Regulations shall be sufficient to meet the requirements of this section.
3.2.3 Liability insurance shall be specific to the packaging, transportation, disposal, storage and delivery of radioactive waste.
3.2.4 Shippers maintaining liability insurance for the purpose of this regulation may provide to the Department a certificate of insurance from their insurer indicating the policy number, limits of liability, policy date and specific coverage for packaging, transportation, disposal, storage and delivery of radioactive materials.
3.2.5 A cash or corporate surety bond previously posted will be returned to the shipper upon notification to the Department in writing of his intention to cease shipments of radioactive waste into or within the State. Such bond will be returned after the last such shipment is accepted safely at its destination.
3.3 Each permit application shall include a certification to the Department that the shipper will comply fully with all applicable State or Federal laws, administrative rules and regulations, licenses, or license conditions of the disposal facility regarding the packaging, transportation, storage, disposal and delivery of radioactive wastes.
3.4 Each permit application shall include a certification that the shipper will hold the State of South Carolina harmless for all claims, actions, or proceedings in law or equity arising out of radiological injury or damage to persons or property occurring during the transportation of its radioactive waste into or within the State including all costs of defending the same; provided, however, that nothing contained herein shall be construed as a waiver of the State's sovereign immunity; and, further provided, that agencies of the State of South Carolina shall not be subject to the requirements of this provision.
3.5 Permit fees will be annually determined and assessed by the Department based on the following classifications:
3.5.1 Class X--more than an annual total of 75 cubic feet or more than 100 curies of radioactive waste for disposal within the State.
3.5.2 Class Y--an annual total of 75 cubic feet or less of radioactive waste consisting of 100 curies or less total activity for disposal within the State.
3.5.3 Class Z--any shipment of radioactive waste which is not consigned for storage or disposal within the State, but which is transported into or within the State.
3.6 Permits will be valid from the date of issuance through December 31 of each calendar year. Permit fees are not refundable. Permits may be renewed by filing a new application with the Department.
4. SHIPPER'S REQUIREMENTS
4.1 Before any shipment of radioactive waste may be transported into or within the State, the shipper shall give written notice to the Department not less than 72 hours nor more than 30 days before the expected date of arrival of the shipment or departure from the shipper's facility within the State as the case may be, except as provided in paragraph 4.1.3.
4.1.1 All prior notifications shall be filed on a Department form designated as RHA-PNC "Radioactive Waste Shipment Prior Notification and Manifest Form."
4.1.2 The shipper shall immediately notify the Department of any cancellations or significant changes in the prior notification or manifest summary which may occur prior to the shipment departing his facility. For example, such changes include changes in date of arrival, carrier, route, waste description, curie content, volume, or waste classification.
4.1.3 For shipments consisting of 75 cubic feet or less containing one curie of radioactive material or less which may be consigned as non-exclusive use shipments according to applicable U.S. Department of Transportation regulations, the requirement for prior notification contained in paragraph 4.1 is waived. Such shipments must otherwise comply with all other applicable requirements regarding the packaging, transportation, storage, disposal and delivery of radioactive wastes.
4.2. The shipper shall provide to the carrier with each separate shipment a copy of the RHA-PNC "Radioactive Waste Shipment Prior Notification and Manifest Form" required by paragraph 4.1. Such copy shall show any changes made pursuant to paragraph 4.1.2 above. Each shipper shall instruct the carrier to comply with the route and schedule contained therein.
4.3 The manifest accompanying each shipment of radioactive waste shall include a copy of the shipper's certification prepared on Department form RHA-CT, Part I, "Radioactive Waste Shipment Certification Form," which shall include certification that the shipment has been inspected and complies with all applicable State and Federal laws and administrative rules and regulations, license or license conditions of the disposal facility regarding the packaging, transportation, storage, disposal and delivery of radioactive wastes.
4.4 Following acceptance of each separate shipment at a disposal facility or at the consignee's facility, it shall be the responsibility of each shipper to provide to the Department for such shipment a copy of Department form RHA-PNC "Radioactive Waste Prior Notification and Manifest Form" with the Consignee Acknowledgement properly executed and to provide the Department with the "Radioactive Waste Shipment Certification Form," Department form RHA-CT, which accompanied that shipment.
5. CARRIER REQUIREMENTS
5.1 For each shipment of radioactive waste materials shipped into or within the State, a carrier shall complete Part II: Carrier's Certification on the form RHA-CT provided by the shipper. The certificate shall be signed by a principal, officer, partner, responsible employee or other authorized agent of the carrier.
5.1.1 The carrier shall certify that the shipment is properly placarded for transport and that all shipping papers required by law and administrative rules and regulations have been properly executed; and,
5.1.2 that the transport vehicle has been inspected and meets the applicable requirements of the Federal government and the State of South Carolina, and that all safety and operational components are in good operative condition; and,
5.1.3 that the carrier has received a copy of the shipper's "Radioactive Waste Prior Notification and Manifest Form," specified in paragraph 4.2 and the "Radioactive Waste Shipment Certification Form," form RHA-CT specified in paragraph 4.3; and,
5.1.4 that the carrier shall comply fully with all applicable laws and administrative rules and regulations, both State and Federal, regarding the transportation of such waste.
5.2 A carrier shall immediately notify the Department of any variance, occurring after departure, from the primary route and estimated date of arrival of shipment as provided by the shipper on Form RHA-PNC.
5.3 The copies of Forms RHA-CT and RHA-PNC shall accompany the shipment to the destination and shall be presented together with the manifest and other shipping papers.
6. DISPOSAL FACILITY OPERATOR
6.1 Owners and operators of disposal facilities shall permanently record, and report to the Department within twenty-four (24) hours after discovery, all conditions in violation of the requirements of this regulation discovered as a result of inspections required by any license under which the facility is operated.
6.2 Prior to the receipt of radioactive wastes at a disposal facility in this State, the owners and operators of such facility shall notify each shipper of any special requirements, if any, in effect regarding the packaging, transportation, storage, disposal or delivery of such wastes at that facility.
6.3 No owner or operator of a disposal facility located within this State shall accept radioactive waste for storage or disposal unless the shipper of such waste has a valid, unsuspended permit issued pursuant to this regulation.
7. PENALTIES
7.1 Any person who commits a radiological violation shall:
7.1.1 be fined not less that One Thousand Dollars ($1,000.00) nor more than Five Thousand Dollars ($5,000.00); and,
7.1.2 if such person is a shipper, have his permit suspended for a period of not less than thirty (30) days and until such time as he demonstrates to the Department's satisfaction that adequate measures have been taken to prevent reoccurrence of the violation.
7.2. Any person who commits a second radiological violation within twelve (12) months of the first such violation shall:
7.2.1 be fined not less than Five Thousand ($5,000.00) nor more than Twenty-five Thousand Dollars ($25,000.00); and,
7.2.2 if such person is a shipper, have his permit suspended for a period of not more than one year and until such time as he demonstrates to the satisfaction of the Department that adequate measures have been taken to prevent reoccurrence of the violations.
7.3 Any person who commits a non-radiological violation of the provisions of this regulation shall be fined not more than One Thousand Dollars ($1,000.00) for each violation; provided, that should the Department determine that a series of such violations has occurred, the Department shall suspend or revoke that person's permit for a period of not more than twelve (12) months.
7.4. Any person to whom an order, injunction, suspension, or fine issued under this article is directed shall comply therewith immediately, but on application to the Department, within twenty (20) days after the date of the order, shall be afforded a hearing within thirty (30) days of such application.
8. SEVERABILITY CLAUSE
8.1 It is hereby declared that each of the sections and provisions of this regulation are severable, and in the event that any one or more of such sections are declared unconstitutional or invalid, the remaining sections and provisions of this regulation shall remain in effect.
ATTACHMENTS
Form RHA-200P SOUTH CAROLINA DEPARTMENT OF HEALTH AND
( 10/80) ENVIRONMENTAL CONTROL APPLICATION
FOR RADIOACTIVE WASTE TRANSPORT PERMIT
Instructions: Complete Items 1 through 8. Submit original and one copy to
Chief, Bureau of Radiological Health, S.C. Dept. of Health and
1501. Arrangements for Fire Department Response/Protection
1502. Tests and Inspections
1503. Fire Response Training
1504. Fire Drills
Section 1600--MAINTENANCE
1601. General
Section 1700--INFECTION CONTROL AND ENVIRONMENT
1701. Staff Practices
1702. Tuberculin Skin Testing
1703. Housekeeping
1704. Infectious Waste
1705. Pets
1706. Clean/Soiled Linen and Clothing
Section 1800--QUALITY IMPROVEMENT PROGRAM
1801. General
Section 1900--DESIGN AND CONSTRUCTION
1901. General
1902. Local and State Codes and Standards
1903. Construction/Systems
1904. Submission of Plans and Specifications
Section 2000--GENERAL CONSTRUCTION REQUIREMENTS
2001. Height and Area Limitations
2002. Fire-Resistive Rating
2003. Vertical Openings
2004. Wall and Partition Openings
2005. Ceiling Openings
2006. Firewalls
2007. Floor Finishes
2008. Wall Finishes
2009. Curtains and Draperies
Section 2100--HAZARDOUS ELEMENTS OF CONSTRUCTION
2101. Furnaces and Boilers
2102. Dampers
Section 2200--FIRE PROTECTION EQUIPMENT AND SYSTEMS
2201. Firefighting Equipment
2202. Automatic Sprinkler System
2203. Fire Alarms
2204. Smoke Detectors
2205. Flammable Liquids
2206. Gases
2207. Furnishings/Equipment
Section 2300--EXITS
2301. Number and Locations of Exits
Section 2400--WATER SUPPLY/HYGIENE
2401. Design and Construction
2402. Disinfection of Water Lines
2403. Temperature Control
2404. Stop Valves
2405. Cross-connections
2406. Design and Construction of Wastewater Systems
Section 2500--ELECTRICAL
2501. General
2502. Panelboards
2503. Lighting
2504. Receptacles
2505. Ground Fault Protection
2506. Exit Signs
2507. Emergency Electric Service
Section 2600--HEATING, VENTILATION, AND AIR CONDITIONING
2601. General
Section 2700--PHYSICAL PLANT
2701. Facility Accommodations/Floor Area
2702. Resident Rooms
2703. Resident Room Floor Area
2704. Bathrooms/Restrooms
2705. Doors
2706. Elevators
2707. Corridors
2708. Ramps
2709. Landings
2710. Handrails/Guardrails
2711. Screens
2712. Windows/Mirrors
2713. Janitor's Closet
2714. Storage Areas
2715. Telephone Service
2716. Location
2717. Outdoor Area
Section 2800--SEVERABILITY
2801. General
Section 2900--GENERAL
2901. General
Section 100--DEFINITIONS AND LICENSE REQUIREMENTS
101. Definitions.
For the purpose of this regulation, the following definitions shall apply:
A. 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; writing letters; making telephone calls; obtaining appointments; administration of medication; and other similar activities.
B. Administering Medication. The direct application of a single dose of a medication to the body of a resident by injection, ingestion, or any other means.
C. Administrator. The individual 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. Advanced Practice Registered Nurse. An individual who has Official Recognition as such by the S.C. Board of Nursing.
F. Alzheimer's Special Care Unit or Program. A facility or area within a facility providing a secure, segregated 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. Once each 365 days.
H. Architect. An individual currently registered as such by the S.C. State Board of Architectural Examiners.
I. Assessment. A procedure for determining the nature and extent of the problem(s) and needs of a potential resident/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 potential resident/resident. Consideration of each resident's needs, strengths, and weaknesses shall be included in the assessment.
J. Authorized Healthcare Provider. An individual authorized by law and currently licensed in S.C. to provide specific treatments, care, or services to residents. Examples of individuals who may be authorized by law to provide the aforementioned treatment/care/services may include, but are not limited to, advanced practice registered nurses, physician's assistants.
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 which 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 community residential care facility.
M. Controlled Substance. A medication or other substance included in Schedule I, II, II, IV, and V of the Federal Controlled Substances Act and the South Carolina Controlled Substances Act.
N. Consultation. A visit to a licensed facility by individuals authorized by the Department to provide information to facilities to enable/encourage facilities to better comply with the regulations.
O. Dentist. An individual currently licensed to practice dentistry by the S.C. Board of Dentistry.
P. Dietitian. A person who is registered by the Commission on Dietetic Registration.
Q. Department. The S.C. Department of Health and Environmental Control (DHEC).
R. Designee. A staff member designated by the administrator to act on his/her behalf.
S. Direct Care Staff Member/Direct Care Volunteer. Those individuals who provide assistance with activities of daily living to residents.
T. Discharge. The point at which residence in a facility is terminated and the facility no longer maintains active responsibility for the care of the resident.
U. Dispensing Medication. The transfer of possession of one or more doses of a drug or device by a licensed pharmacist or person as permitted by law, to the ultimate consumer or his/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.
V. Existing Facility. A facility which was in operation and/or one which, as approved by the Department, began the construction or renovation of a building, for the purpose of operating the facility, prior to the promulgation of this regulation. The licensing standards governing new facilities apply if and when an existing facility is not continuously operated and licensed under this regulation.
W. Facility. A community residential care facility licensed by the Department.
X. Health Assessment. An evaluation of the health status of a staff member/volunteer by a physician, other 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.
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 assessment data and which is to be implemented for the benefit of the resident.
Z. Initial License. A license granted to a new facility.
AA. Inspection. A visit by authorized individuals to a facility or to a proposed facility for the purpose of determining compliance with this regulation.
BB. Investigation. A visit by authorized individuals to a licensed or unlicensed entity for the purpose of determining the validity of allegations received by the Department relating to this regulation.
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 is a legend 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 a 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 nurse or licensed practical nurse.
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, to secure/provide health care for residents. 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 and needs.
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. New Facility. All buildings or portions of buildings, new and existing building(s), that are:
1. Being licensed for the first time;
2. Providing a different service that requires a change in the type of license;
3. Being licensed after the previous licensee's license has been revoked, suspended, or after the previous licensee has voluntarily surrendered the license and the facility has not continuously operated.
JJ. Nonlegend Drug. A drug which may be sold without a prescription and which is labeled for use by the consumer in accordance with the requirements of the laws of this State and the federal government.
KK. Peak Hours. Those hours from 7 a.m. to 7 p.m., or as otherwise determined by the facility, which shall be justifiable and reasonable, and in consideration of residents' presence in the facility, and acuity of their needs.
LL. 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 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.
MM. Personal Monies. All monies which are available to the resident for his/her personal use, including family donations.
NN. Pharmacist. An individual currently registered as such by the S.C. Board of Pharmacy.
OO. Physical Examination. An examination of a resident by a physician or other authorized healthcare provider which 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's Assistant. An individual currently licensed as such by the S.C. Board of Medical Examiners.
RR. 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 higher quality of care/services for the facility's residents.
SS. Ramp. An inclined accessible route that facilitates entrance to or egress from or within a facility.
TT. 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, grandchild, niece, nephew, grandparent, great-grandparent, grandchild, or great-grandchild.
UU. 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.
VV. Resident. Any individual, other than staff members/volunteers or owner and their family members, who resides in a facility.
WW. Resident Room. An area enclosed by four ceiling high walls that can house one or more residents of the facility.
XX. 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.
YY. 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.
ZZ. Restraint A device which inhibits the movement of a resident, e.g., posey vest, geri-chair.
AAA. Revocation of License. An action by the Department to cancel or annul a facility license by recalling, withdrawing, or rescinding its authority to operate.
BBB. 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.
CCC. Staff Member. An adult, to include the administrator, who is a compensated employee of the facility on either a full or part-time basis.
DDD. Suspend 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.
EEE. Volunteer. An adult who performs tasks at the facility at the direction of the administrator without compensation.
102. .
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. S.C. Guidelines for Prevention and Control of Antibiotic Resistant Organisms.
B. The following non-Departmental publications are referenced within this regulation:
1. Standard Building Code;
2. National Fire Protection Association (NFPA) 101, Life Safety Code, and other NFPA standards, as applicable;
3. National Electrical Code;
4. Standard Plumbing Code;
5. Standard Mechanical Code;
6. Standard Gas Code;
7. State Fire Marshal Regulations;
8. American National Standards Institute (ANSI) 117.1, Specifications for Making Building and Facilities Accessible to and Useable by the Physically Handicapped;
11. Occupational Safety and Health Act of 1970 (OSHA);
12. Omnibus Adult Protection Act;
13. Alzheimer's Special Care Disclosure Act;
14. Food and Nutrition Board of the National Research Council, National Academy of Sciences;
15. National Sanitation Federation;
16. Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Healthcare Facilities;
17. U.S. Pharmacopoeia.
C. The Department shall enforce new laws that may change the above-noted standards and at its discretion adopt revisions to the above noted references.
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/assisted living facility in S.C. without first obtaining a license from the Department. Admission of residents prior to the effective date of licensure is a violation of Section 44-7-260(A)(6) of the S.C. Code of Laws, 1976, as amended. 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 which 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 been not 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 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 (existing facilities), and proposed facilities for which the licensee has received written approval from the Department to construct the proposed facility:
1. Shall be allowed to continue utilizing the previously-licensed structure without modification. Facilities are not required to modify square footage of resident rooms, sitting areas, and maximum number of beds in resident rooms, or provide a private resident room except that facilities that have resident rooms with five or more licensed beds shall reduce the maximum number of beds per room to no more than four within 12 months from the date of promulgation of this regulation.
2. Shall comply with the remainder of the standards within this regulation.
D. Compliance with Structural Standards upon Change of Ownership. When changes in ownership occur, the new licensee shall, through coordination with the Department's Division of Health Facilities Construction, formulate a plan for the facility to be in compliance with current building and fire and life safety codes within 24 months of the date of the ownership change, unless specific standards are exempted by the Department. Facilities are not required to modify square footage of resident rooms and maximum number of beds in resident rooms, except that those facilities which have resident rooms with five or more licensed beds shall reduce the maximum number of beds per room to no more than four within 12 months from the date of ownership change.
E. 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)
F. 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)
EXCEPTION: In the event that the facility temporarily provides shelter for evacuees who have been displaced due to a disaster, then for the duration of that emergency, provided the health, safety, and well-being of all residents are not compromised, it is permissible to temporarily exceed the licensed capacity for the facility in order to accommodate these individuals (See Section 606).
G. 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 staff members/family/volunteers nor shall bedrooms of staff members/family/volunteers be utilized by residents.
H. 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 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.
6. Separate licenses are not required, but may be issued, for separate buildings on the same or adjoining grounds where a single level or type of care is provided.
7. Multiple types of facilities on the same premises shall be licensed separately even though owned by the same entity.
8. Facilities may furnish respite care provided compliance with the standards of this regulation is met.
I. 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.
J. Application. Applicants for a license shall submit to the Department a completed 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 governmental 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 partnerships shall be registered with the S.C. Office of the Secretary of State.
K. Licensee. A licensee shall submit original letters of reference from three persons not related to, nor employed by the licensee, that attest to the licensee's reputable and responsible character, and the financial ability and competence to operate a community residential care facility (if owner is a corporation, then references for the chief executive officer of the corporation; if a partnership, then references for each partner owning five percent or more). One of the references shall be the result of a criminal background check with S.C. State Law Enforcement, or by letter from the local police department. For out-of-state licensees, references shall include a criminal background check from that state, in addition to S.C.. The licensee shall be financially able to meet all obligations necessary to the proper operation of the facility.
L. 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 money order 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, a portion of the fee shall be refunded based upon the remaining months of the licensure year, or $75.00, whichever is lesser.
M. 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.
N. 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.
O. Change of License.
1. A facility shall request 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 letter from the licensee.
P. Exceptions to Licensing Standards. The Department has the authority to make exceptions to these standards where it is determined that the health, safety, and well-being of the residents are not compromised, and provided the standard is not specifically required by statute.
Section 200--ENFORCING REGULATIONS
201. General.
The Department shall utilize inspections, investigations, consultations, and other pertinent documentation regarding a proposed or licensed facility in order to enforce this regulation.
202. Inspections/Investigations.
A. Inspections by the Department shall be conducted prior to initial licensing of a facility and subsequent inspections conducted as deemed appropriate by the Department. (I)
B. All facilities are subject to inspection/investigation at any time without prior notice by individuals authorized by S.C. Code of Laws. When staff members/volunteers/residents are absent, the facility shall provide information to those seeking legitimate access to the facility, including visitors, as to the expected return of staff members/volunteers/residents. (I)
C. Individuals authorized by S.C. law shall be granted access to all properties and areas, objects, and records in a timely manner, and have the authority to require the facility to make photocopies of those documents required in the course of inspection
