reglab/statecodes huggingface dataset:
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-15 - CERTIFICATION OF NEED FOR HEALTH FACILITIES AND SERVICES › Part A - QUESTIONNAIRE-APPLICATION › Chapter 1 - DEFINITIONS AND APPLICABILITY › Section 61-15.A.1.105 - South Carolina Health Plan

Current through Register Vol. 48, No. 6, June 28, 2024
1. With the advice of the health planning committee, the Department shall prepare a South Carolina Health Plan for use in the administration of the Certificate of Need Program. The plan, at a minimum, must include:
a. an inventory of existing health care facilities, beds, specified health services, and equipment;
b. projections of need for additional health care facilities, beds, health services, and equipment;
c. standards for distribution of health care facilities, beds, specified health services, and equipment including scope of services to be provided, utilization, and occupancy rates, travel time, regionalization, other factors relating to proper placement of service, and proper planning of health care facilities; and
d. a general statement as to the project review criteria considered most important in evaluating Certificate of Need applications for each type of facility, service, and equipment, including a finding as to whether the benefits of improved accessibility to each such type of facility, service, and equipment, may outweigh the adverse affects caused by the duplication of any existing facility, service, or equipment.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-15 - CERTIFICATION OF NEED FOR HEALTH FACILITIES AND SERVICES › Part A - QUESTIONNAIRE-APPLICATION › Chapter 2 - APPLICATION PROCEDURES › Section 61-15.A.2.201 - Public Notification

Current through Register Vol. 48, No. 6, June 28, 2024
1. Within twenty (20) calendar days prior to submission of an application, the applicant shall publish notification that an application is to be submitted to the Department in the legal section of a daily newspaper serving the area where the project is to be located for three (3) consecutive days. The notification must contain at least the following information:
a. that a Certificate of Need is being applied for;
b. a description of the scope and nature of the project; and
c. the estimated project capital cost.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-15 - CERTIFICATION OF NEED FOR HEALTH FACILITIES AND SERVICES › Part A - QUESTIONNAIRE-APPLICATION › Chapter 3 - DISPOSITION OF APPLICATION › Section 61-15.A.3.301 - Submission of Application

Current through Register Vol. 48, No. 6, June 28, 2024
1. The application shall be submitted utilizing the web-based application available on the Department's website or by such other means the Department may provide.
2. A non-refundable filing fee of five hundred dollars ($500) shall be received by the Bureau of Operations Support, S.C. Department of Health and Environmental Control, 2600 Bull Street, Columbia, SC, 29201, within twenty (20) calendar days of the public notification pursuant to Section 201 and the Certificate of Need application pursuant to Section 301.1.
3. Applicants are encouraged to involve the Department in the development of proposed projects prior to the submission of an application.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-15 - CERTIFICATION OF NEED FOR HEALTH FACILITIES AND SERVICES › Part A - QUESTIONNAIRE-APPLICATION › Chapter 3 - DISPOSITION OF APPLICATION › Section 61-15.A.3.302 - Additional Information

Current through Register Vol. 48, No. 6, June 28, 2024
1. Within fifteen (15) calendar days of acceptance of the application, the Department may request additional information as may be necessary to complete the application. Should additional information be required for an application to be considered complete, the applicant will have fifteen (15) calendar days from the date of the request to submit the requested information. If the applicant does not submit the requested information within fifteen (15) calendar days, the application will be deemed withdrawn.
2. If any deadline provided for in this section falls on a weekend or State holiday, the deadline will be extended until the next calendar day that is not a weekend or State holiday.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-15 - CERTIFICATION OF NEED FOR HEALTH FACILITIES AND SERVICES › Part A - QUESTIONNAIRE-APPLICATION › Chapter 3 - DISPOSITION OF APPLICATION › Section 61-15.A.3.303 - Payment of Filing and Application Fees

Current through Register Vol. 48, No. 6, June 28, 2024
1. When the application is determined to be complete, the Department shall invoice the applicant, by certified mail, for the Certificate of Need application fee. The applicant shall have fifteen (15) calendar days from the date of receipt of the invoice to pay the fee by valid check or credit card made payable to the S.C. Department of Health and Environmental Control. Should the application fee not be received from the applicant within fifteen (15) calendar days from receipt of the Department's invoice, the application will be considered withdrawn.
2. The application fee is one half of one percent (.5%, .005) of the total project cost (as defined in Section 102), which is payable when the application is deemed complete. The application fee shall not exceed seven thousand dollars ($7,000).
3. If any deadline provided for in this section falls on a weekend or State holiday, the deadline will be extended until the next calendar day that is not a weekend or State holiday.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-15 - CERTIFICATION OF NEED FOR HEALTH FACILITIES AND SERVICES › Part A - QUESTIONNAIRE-APPLICATION › Chapter 3 - DISPOSITION OF APPLICATION › Section 61-15.A.3.304 - Relative Importance Criteria

Current through Register Vol. 48, No. 6, June 28, 2024
1. Upon determination by the Department that an application is complete, the Department shall notify the applicant, by certified mail, of the relative importance of the project review criteria to be used in reviewing the application. The applicant will have thirty (30) calendar days from the date of receipt of this notice to submit any additional information. If, subsequent to this notice, the Department determines that the relative importance of the review criteria has changed, the Department must again notify the applicant by certified mail. The applicant will have thirty (30) calendar days from receipt of the revised notice to submit any additional information.
2. The staff may reorder the relative importance of the project review criteria no more than one (1) time. The staff's reordering of the relative importance of the project review criteria does not extend the review period.
3. When an application has been appealed, the Department may not change the weight of the importance of the project review criteria.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-15 - CERTIFICATION OF NEED FOR HEALTH FACILITIES AND SERVICES › Part A - QUESTIONNAIRE-APPLICATION › Chapter 3 - DISPOSITION OF APPLICATION › Section 61-15.A.3.305 - Review Time Frames

Current through Register Vol. 48, No. 6, June 28, 2024
1. Upon determination by the Department that the application is complete, the Department shall publish in the State Register a notice that the review cycle for the project has begun. Any affected person who has notified the Department in writing that they desire to be notified of the beginning of the review period will be sent a copy of the notification.
2. The Department will make a decision on the complete application no earlier than thirty (30) calendar days but no later than ninety (90) calendar days of the date of publication in the State Register unless a public hearing is held. If a public hearing is held pursuant to Section 306, the Department will render its decision no later than one hundred twenty (120) calendar days from the date the affected persons are notified that the application is complete. Notice of a Department decision must be sent by certified mail, return receipt requested, to the applicant and affected persons who have requested in writing to be notified. Affected persons may request in writing to be notified by regular mail or electronic mail in lieu of certified mail.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-15 - CERTIFICATION OF NEED FOR HEALTH FACILITIES AND SERVICES › Part A - QUESTIONNAIRE-APPLICATION › Chapter 3 - DISPOSITION OF APPLICATION › Section 61-15.A.3.306 - Public Hearing

Current through Register Vol. 48, No. 6, June 28, 2024
A public hearing must be requested in writing by an affected person as defined in this regulation within thirty (30) calendar days of the notification of the beginning of a review. Where such a hearing is requested, prior notice of the hearing will be provided to affected persons. The written notification of the hearing shall include the proposed schedule for the review, time, date, and place of such hearing. The public hearing shall provide an opportunity for any person to present information relevant to the application.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-15 - CERTIFICATION OF NEED FOR HEALTH FACILITIES AND SERVICES › Part A - QUESTIONNAIRE-APPLICATION › Chapter 3 - DISPOSITION OF APPLICATION › Section 61-15.A.3.307 - Department Review

Current through Register Vol. 48, No. 6, June 28, 2024
1. The Department may not issue a Certificate of Need unless an application is in compliance with the South Carolina Health Plan as described in this regulation, project review criteria, and other provisions in this regulation which must be identified by the Department. The Department may refuse to issue a Certificate of Need even if an application is in compliance with the South Carolina Health Plan but is inconsistent with project review criteria or other provisions in this regulation. The Department must identify any provisions in this regulation that are used as a basis for denying an application that is in compliance with the South Carolina Health Plan.
2. In the case of competing applications, the Department shall award a Certificate of Need, if appropriate, on the basis of which, if any, most fully complies with the requirements, goals, and purposes of the Certificate of Need program, South Carolina Health Plan, project review criteria, and any provisions in this regulation.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-15 - CERTIFICATION OF NEED FOR HEALTH FACILITIES AND SERVICES › Part A - QUESTIONNAIRE-APPLICATION › Chapter 3 - DISPOSITION OF APPLICATION › Section 61-15.A.3.308 - Department Decision

Current through Register Vol. 48, No. 6, June 28, 2024
On the basis of staff review of the record established by the Department, including but not limited to, the application, comments from affected persons and other persons concerning the application, data, studies, literature and other information available to the Department, the staff of the Department shall make a proposed decision to grant or deny the Certificate of Need.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-15 - CERTIFICATION OF NEED FOR HEALTH FACILITIES AND SERVICES › Part A - QUESTIONNAIRE-APPLICATION › Chapter 3 - DISPOSITION OF APPLICATION › Section 61-15.A.3.309 - Certificate of Need Issuance Fee

Current through Register Vol. 48, No. 6, June 28, 2024
Approved projects with a total project cost greater than one million four hundred thousand dollars ($1,400,000) will require payment of a Certificate of Need issuance fee of seven thousand five hundred dollars ($7,500). The Department must receive payment from the applicant within fifteen (15) calendar days from receipt of the certificate for the Certificate of Need to remain valid.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-15 - CERTIFICATION OF NEED FOR HEALTH FACILITIES AND SERVICES › Part A - QUESTIONNAIRE-APPLICATION › Chapter 3 - DISPOSITION OF APPLICATION › Section 61-15.A.3.310 - Project Changes During Review Period

Current through Register Vol. 48, No. 6, June 28, 2024
If an applicant amends the application during the review process, the Department will determine whether or not the amendment is substantial and constitutes a new application. If the change is not substantial and results in an increase in total project cost, the fees will be adjusted accordingly.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-15 - CERTIFICATION OF NEED FOR HEALTH FACILITIES AND SERVICES › Part A - QUESTIONNAIRE-APPLICATION › Chapter 3 - DISPOSITION OF APPLICATION › Section 61-15.A.3.311 - Validity of Certificate of Need Issued

Current through Register Vol. 48, No. 6, June 28, 2024
The Certificate of Need, if issued, is valid only for the project described in the application including location, beds, and services to be offered, physical plant, capital or operating costs, or other factors as set forth in the application, except as may be modified in accordance with this regulation. Implementation of the project or operation of the facility or medical equipment that is not in accordance with the Certificate of Need application or conditions subsequently agreed to by the applicant and the Department may be considered a violation of this regulation.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-15 - CERTIFICATION OF NEED FOR HEALTH FACILITIES AND SERVICES › Part A - QUESTIONNAIRE-APPLICATION › Chapter 3 - DISPOSITION OF APPLICATION › Section 61-15.A.3.312 - Contact with the Board

Current through Register Vol. 48, No. 6, June 28, 2024
1. After a Certificate of Need application has been filed with the Department, state and federal elected officials are prohibited from communicating with the Department with regard to the Certificate of Need application at any time. This prohibition does not include written communication of support or opposition to an application. Such written communication must be included in the administrative record.
2. From the date of publication of notice in the local newspaper that an application is being filed and until the date final review is requested under Section 401 of this regulation:
a. members of the Board and persons appointed by the Board to hold a final review conference on staff decisions may not communicate directly or indirectly with any person in connection with the application; and
b. no person shall communicate, or cause another to communicate, as to the merits of the application with members of the Board and persons appointed by the Board to hold a final review conference on staff decisions.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-15 - CERTIFICATION OF NEED FOR HEALTH FACILITIES AND SERVICES › Part A - QUESTIONNAIRE-APPLICATION › Chapter 4 - APPEALS › Section 61-15.A.4.401 - Appeal of Decision

Current through Register Vol. 48, No. 6, June 28, 2024
1. A Department decision involving the issuance, denial, or revocation of a Certificate of Need may be appealed by an affected person pursuant to applicable law, including S.C. Code Title 44, Chapter 1; Title 1, Chapter 23; and Title 44, Chapter 7.
2. A person may not file a request for final review in opposition to the staff decision on a Certificate of Need unless the person provided written notice to the Department during the staff review that they are an affected person and specifically states their grounds for opposition to the application under review.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-15 - CERTIFICATION OF NEED FOR HEALTH FACILITIES AND SERVICES › Part A - QUESTIONNAIRE-APPLICATION › Chapter 5 - GENERAL PROVISIONS › Section 61-15.A.5.501 - Periodic Reports

Current through Register Vol. 48, No. 6, June 28, 2024
For the purpose of health planning, health care facilities and others who provide services that require a Certificate of Need or who have been exempted, shall on an annual basis submit information requested on the applicable Joint Annual Report.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-15 - CERTIFICATION OF NEED FOR HEALTH FACILITIES AND SERVICES › Part A - QUESTIONNAIRE-APPLICATION › Chapter 5 - GENERAL PROVISIONS › Section 61-15.A.5.502 - Review Under Applicable Plan

Current through Register Vol. 48, No. 6, June 28, 2024
All decisions on Certificate of Need applications shall be made based on the currently approved South Carolina Health Plan in effect at the time such application is accepted. Should a new plan be adopted during any phase of the review or appeals process, the applicant shall have the option of withdrawing the application and resubmitting under the newly adopted plan or continuing the review or appeal process under the plan in use when the application was submitted. In cases where applications are withdrawn and resubmitted under the newly adopted South Carolina Health Plan within forty-five (45) calendar days of the date of withdrawal, no additional filing fee shall be required.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-15 - CERTIFICATION OF NEED FOR HEALTH FACILITIES AND SERVICES › Part A - QUESTIONNAIRE-APPLICATION › Chapter 6 - VOIDANCE AND EXTENSION OF CERTIFICATES OF NEED › Section 61-15.A.6.601 - Voidance and Extension Procedures

Current through Register Vol. 48, No. 6, June 28, 2024
1. The Certificate of Need shall become void twelve months (one year) from the date of issuance unless implemented as described in this subsection or a timely extension request is received pursuant to Section 602. The Department may void a Certificate of Need if requested by the applicant. Implementation may be evidenced by, but not limited to, a properly negotiated valid construction contract or appropriate purchase order for service projects.
2. A Certificate of Need must be issued with a timetable submitted by the applicant, and approved by the Department, to be followed for completion of the project. The holder of the Certificate of Need must submit quarterly progress reports documenting compliance with the aforementioned timetable. Failure to meet the timetable will result in the revocation of the Certificate of Need by the Department unless the Department determines that extenuating circumstances beyond the control of the holder of the Certificate of Need are the cause of the delay. If the applicant has not met the approved timetable, documented evidence that extenuating circumstances beyond the control of the holder of the Certificate of Need should be provided to the Department. This information can also be included in a request for an extension as provided in Section 602.
3. The Department may grant up to two (2) extensions of up to nine (9) months each. In order to obtain an extension, the applicant must have demonstrated substantial progress and must either be complying with the approved timetable or have submitted documentation satisfactory to the Department that extenuating circumstances beyond the control of the applicant have prevented compliance with the timetable. After the nine (9) month extension period, the Certificate of Need will expire and become void.
4. However, the Board may grant further extensions of the Certificate of Need of up to nine (9) months each if it determines that substantial progress has been made. A request to the Board must be made at least three (3) months prior to the expiration of the Certificate of Need and must contain justification for such extension.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-15 - CERTIFICATION OF NEED FOR HEALTH FACILITIES AND SERVICES › Part A - QUESTIONNAIRE-APPLICATION › Chapter 6 - VOIDANCE AND EXTENSION OF CERTIFICATES OF NEED › Section 61-15.A.6.602 - Extension Request

Current through Register Vol. 48, No. 6, June 28, 2024
1. A Certificate of Need extension shall be requested in writing by the applicant at least thirty (30) calendar days before the expiration date of the Certificate of Need.
2. The written request for an extension shall include at least the following:
a. A detailed description of any changes in the configuration, costs, services, or scope of the project.
b. A detailed description and documentation of any progress on the project including preparation of construction drawings, the securing of necessary funds and building permits, and commencement of any construction.
c. An estimated timetable for commencement and completion of all remaining components of the project.
d. Documentation of compliance with the approved timetable or documented evidence that extenuating circumstance beyond the control of the applicant if the timetable was not met.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-15 - CERTIFICATION OF NEED FOR HEALTH FACILITIES AND SERVICES › Part A - QUESTIONNAIRE-APPLICATION › Chapter 6 - VOIDANCE AND EXTENSION OF CERTIFICATES OF NEED › Section 61-15.A.6.603 - Criteria for Extension

Current through Register Vol. 48, No. 6, June 28, 2024
The following criteria shall be used to determine whether substantial progress has been made by the applicant:
1. Site procurement: The applicant should have made definitive progress toward permanent acquisition of the intended site. Such progress may include purchase of property previously under option or consummation of long-term lease agreements.
2. Architectural Progress: The facility architect should have been employed and definitive progress should be made toward development of final drawings.
3. Financial Status: The applicant should document definitive progress toward finalizing any necessary loans or lease-purchase arrangements.
4. The applicant should provide reasonable assurance that the project will be under construction or implemented within the requested extension time frame.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-15 - CERTIFICATION OF NEED FOR HEALTH FACILITIES AND SERVICES › Part A - QUESTIONNAIRE-APPLICATION › Chapter 6 - VOIDANCE AND EXTENSION OF CERTIFICATES OF NEED › Section 61-15.A.6.604 - Non-Transferability of Certificate of Need

Current through Register Vol. 48, No. 6, June 28, 2024
1. A Certificate of Need is nontransferable. A Certificate of Need or rights there under may not be sold, assigned, leased, transferred, mortgaged, pledged, or hypothecated, and any actual transfer or attempt to make a transfer of this sort will result in the immediate voidance of the Certificate of Need. Any of the aforementioned transactions involving an entity directly or indirectly holding a Certificate of Need before fulfillment of the Certificate of Need will result in the transfer and the subsequent voidance of the Certificate of Need.
2. The sale or transfer of the controlling interest or majority ownership in a corporation, partnership, or other entity holding, either directly or indirectly, a Certificate of Need, will result in the transfer and voidance of a Certificate of Need.
3. Fulfillment of the Certificate of Need occurs upon the submission of an adequate final completion report pursuant to Section 607.3.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-15 - CERTIFICATION OF NEED FOR HEALTH FACILITIES AND SERVICES › Part A - QUESTIONNAIRE-APPLICATION › Chapter 6 - VOIDANCE AND EXTENSION OF CERTIFICATES OF NEED › Section 61-15.A.6.605 - Project Changes After Receipt of Certificate of Need

Current through Register Vol. 48, No. 6, June 28, 2024
If an applicant amends or alters their project after receipt of a Certificate of Need, the Department will decide whether or not the amendment is substantial and thereby constitutes a new project.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-15 - CERTIFICATION OF NEED FOR HEALTH FACILITIES AND SERVICES › Part A - QUESTIONNAIRE-APPLICATION › Chapter 6 - VOIDANCE AND EXTENSION OF CERTIFICATES OF NEED › Section 61-15.A.6.606 - Maximum Capital Expenditures

Current through Register Vol. 48, No. 6, June 28, 2024
In issuing a Certificate of Need, the Department shall specify the approved total project cost. A project is only approved for the amount specified in the Certificate of Need. The Department will review cost overruns on an individual basis.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-15 - CERTIFICATION OF NEED FOR HEALTH FACILITIES AND SERVICES › Part A - QUESTIONNAIRE-APPLICATION › Chapter 6 - VOIDANCE AND EXTENSION OF CERTIFICATES OF NEED › Section 61-15.A.6.607 - Periodic Reporting of Certificate of Need Implementation

Current through Register Vol. 48, No. 6, June 28, 2024
1. The applicant is required to submit a quarterly progress report that corresponds with the timetable included in the Certificate of Need application beginning ninety (90) calendar days after receipt of the Certificate of Need. Failure to meet the timetable will result in the revocation of the Certificate of Need by the Department unless a determination is made by the Department that circumstances beyond the control of the holder of the Certificate of Need are the cause of the delay.
2. The applicant shall report on, if applicable:
(1) costs incurred on the project;
(2) construction activity;
(3) program or service activity; and
(4) any deviations from the submitted application with supporting documentation.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-15 - CERTIFICATION OF NEED FOR HEALTH FACILITIES AND SERVICES › Part A - QUESTIONNAIRE-APPLICATION › Chapter 7 - PENALTIES FOR NON-COMPLIANCE › Section 61-15.A.7.701 - Health Services to be Offered or Developed

Current through Register Vol. 48, No. 6, June 28, 2024
Undertaking any activity requiring Certificate of Need review, pursuant to Section 102 of this regulation, without prior approval of the Department or failing to comply with any of the above stated regulations shall be grounds for the denial, suspension, or revocation of the Certificate of Need, or other penalties, under the provisions of the Health Facility Licensure Act, S.C. Code Ann. Sections 44-7-110
et seq.
, as amended.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-15 - CERTIFICATION OF NEED FOR HEALTH FACILITIES AND SERVICES › Part A - QUESTIONNAIRE-APPLICATION › Chapter 8 - PROJECT REVIEW CRITERIA › Section 61-15.A.8.801 - Applicability and Weighting

Current through Register Vol. 48, No. 6, June 28, 2024
1. The criteria listed in Section 802 are to be used in reviewing all projects under the Certification of Need program. These criteria have been grouped under the following general categories:
Need for the Proposed Project (Section 802.1 through 802.4)
Economic Consideration (Section 802.5 through 802.9)
Health System Resources (Section 802.10 through 802.14)
Site Suitability (Section 802.15)
Special Consideration (Section 802.16 through 802.18)
2. The Department shall notify the applicant of the relative importance of the project review criteria to be used in reviewing the application. The relative importance assigned to each specific criterion is established by the Department depending upon the importance of the criterion applied to the specific project. The relative importance must be consistent for competing projects.
3. A project does not have to satisfy every criterion in order to be approved, but no project may be approved unless it is consistent with the South Carolina Health Plan. A project may be denied if the Department determines that the project does not sufficiently meet one (1) or more of the criteria.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-15 - CERTIFICATION OF NEED FOR HEALTH FACILITIES AND SERVICES › Part A - QUESTIONNAIRE-APPLICATION › Chapter 8 - PROJECT REVIEW CRITERIA › Section 61-15.A.8.802 - Criteria for Project Review

Current through Register Vol. 48, No. 6, June 28, 2024
1. Need:
The proposal shall not be approved unless it is in compliance with the South Carolina Health Plan.
2. Community Need Documentation:
a. The target population should be clearly identified as to the size, location, distribution, and socioeconomic status (if applicable).
b. Projections of anticipated population changes should be reasonable and based upon accepted demographic or statistical methodologies, with assumptions and methodologies clearly presented in the application. The applicant must use population statistics consistent with those generated by the South Carolina Revenue and Fiscal Affairs Office.
c. The proposed project should provide services that meet an identified (documented) need of the target population. The assumptions and methods used to determine the level of need should be specified in the application and based on a reasonable approach as judged by the reviewing body. Any deviation from the population projection used in the South Carolina Health Plan should be explained.
d. In the case of a reduction, relocation, or elimination of a facility or service, the applicant should address the need that the population presently has for the service, the extent to which that need will be met by the proposed relocation or by alternative arrangements, and the effect of the reduction, elimination, or relocation of the service on the ability of low income persons, racial and ethnic minorities, women, the elderly, handicapped persons, and other underserved groups, to obtain needed health care.
e. Current and/or projected utilization should be sufficient to justify the expansion or implementation of the proposed service.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-16 - Minimum Standards for Licensing Hospitals and Institutional General Infirmaries › Sec2 61-16.200 - LICENSE REQUIREMENTS AND FEES › Section 61-16.202 - Variance to Licensing Standards

Current through Register Vol. 48, No. 6, June 28, 2024
A variance is an alternative method that ensures the equivalent level of compliance with the standards in this regulation. The Facility may request a variance to this regulation in a format as determined by the Department. Variances shall be considered on a case-by-case basis by the Department. The Department may revoke issued variances as determined to be appropriate by the Department.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-16 - Minimum Standards for Licensing Hospitals and Institutional General Infirmaries › Sec2 61-16.200 - LICENSE REQUIREMENTS AND FEES › Section 61-16.203 - Exceptions to Licensing Standards

Current through Register Vol. 48, No. 6, June 28, 2024
The Department reserves the right to make exceptions to these
				  standards where it is determined that the health and welfare of the community
				  requires the services of the facility. When an "exception" applies to an
				  existing facility, it will continue to meet the standards in effect at the time
				  it was licensed.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-16 - Minimum Standards for Licensing Hospitals and Institutional General Infirmaries › Sec2 61-16.300 - ENFORCING REGULATIONS AND ENFORCEMENT ACTIONS › Section 61-16.301 - General

Current through Register Vol. 48, No. 6, June 28, 2024
The Department shall utilize inspections, investigations, consultations, and other pertinent documentation regarding a proposed or licensed facility in order to enforce this regulation.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-16 - Minimum Standards for Licensing Hospitals and Institutional General Infirmaries › Sec2 61-16.300 - ENFORCING REGULATIONS AND ENFORCEMENT ACTIONS › Section 61-16.302 - Inspections and Investigations

Current through Register Vol. 48, No. 6, June 28, 2024
A. An inspection shall be conducted prior to initial licensing. Inspections shall be conducted as deemed appropriate by the Department. (I)
B. All facilities, proposed facilities, or unlicensed facilities are subject to inspection or investigation at any time without prior notice by individuals authorized by South Carolina Code of Laws. (II)
C. Individuals authorized by the Department shall be granted access to all properties and areas, objects, and records. If photocopies are made for the Department inspector, they shall be used only for purposes of enforcement of regulations and confidentiality shall be maintained except to verify individuals in enforcement action proceedings. Physical area of inspections shall be determined by the extent to which there is potential impact or effect upon patients as determined by the inspector. (I)
D. A facility or proposed facility found noncompliant with the standards of this regulation shall submit an acceptable plan of correction to the Department that shall be signed by the administrator and returned by the date specified on the report of inspection or investigation. The written plan of correction shall describe: (II)
1. The actions taken to correct each cited deficiency;
2. The actions taken to prevent recurrences (actual and similar); and
3. The actual or expected completion dates of those actions.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-16 - Minimum Standards for Licensing Hospitals and Institutional General Infirmaries › Sec2 61-16.300 - ENFORCING REGULATIONS AND ENFORCEMENT ACTIONS › Section 61-16.303 - Compliance

Current through Register Vol. 48, No. 6, June 28, 2024
A. A license shall not be issued until the licensee has demonstrated to the Department that the proposed facility is in compliance with the licensing standards. In the event a licensee who already has a facility or activity licensed by the Department makes application for another facility or activity or increase in licensed capacity, the currently licensed facility or activity shall be in substantial compliance with the applicable standards prior to the Department issuing a license to the proposed facility or activity or an amended license to the existing facility. Facilities shall comply with applicable State, Federal, and local laws, codes, and regulations. (II)
B. The license is considered property of the Department and may not be duplicated in such a manner that it cannot be distinguished from the original. (II)
C. Any additions or renovations to an existing facility shall be approved by the Department prior to occupancy.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-16 - Minimum Standards for Licensing Hospitals and Institutional General Infirmaries › Sec2 61-16.300 - ENFORCING REGULATIONS AND ENFORCEMENT ACTIONS › Section 61-16.304 - Enforcement Actions

Current through Register Vol. 48, No. 6, June 28, 2024
When the Department determines that a licensee, proposed licensee, or an unlicensed facility owner is in violation of statutory provisions, rules, or regulations relating to the operation of a facility, the Department, upon proper notice to the licensee, may impose a monetary penalty and/or deny, suspend, revoke, or refuse to issue or renew a license.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-16 - Minimum Standards for Licensing Hospitals and Institutional General Infirmaries › Sec2 61-16.300 - ENFORCING REGULATIONS AND ENFORCEMENT ACTIONS › Section 61-16.306 - Deleted

Current through Register Vol. 48, No. 6, June 28, 2024
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-16 - Minimum Standards for Licensing Hospitals and Institutional General Infirmaries › Sec2 61-16.300 - ENFORCING REGULATIONS AND ENFORCEMENT ACTIONS › Section 61-16.307 - Deleted

Current through Register Vol. 48, No. 6, June 28, 2024
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-16 - Minimum Standards for Licensing Hospitals and Institutional General Infirmaries › Sec2 61-16.300 - ENFORCING REGULATIONS AND ENFORCEMENT ACTIONS › Section 61-16.308 - Deleted

Current through Register Vol. 48, No. 6, June 28, 2024
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-16 - Minimum Standards for Licensing Hospitals and Institutional General Infirmaries › Sec2 61-16.300 - ENFORCING REGULATIONS AND ENFORCEMENT ACTIONS › Section 61-16.309 - Deleted

Current through Register Vol. 48, No. 6, June 28, 2024
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-16 - Minimum Standards for Licensing Hospitals and Institutional General Infirmaries › Sec2 61-16.400 - POLICIES AND PROCEDURES › Section 61-16.401 - General. (II)

Current through Register Vol. 48, No. 6, June 28, 2024
A. The Facility shall maintain and adhere to written policies and procedures addressing the manner in which the requirements of this regulation shall be met. The Facility shall develop, implement, and enforce policies and procedures. The Facility shall be in full compliance with the policies and procedures. (II)
B. The Facility shall establish a time period for review of all policies and procedures, and such reviews shall be documented and signed by the Chief Executive Officer (or his/her designee(s)). All policies and procedures shall be accessible to Facility staff, printed or electronically, at all times.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-16 - Minimum Standards for Licensing Hospitals and Institutional General Infirmaries › Sec2 61-16.400 - POLICIES AND PROCEDURES › Section 61-16.402 - Quality of Care. (II)

Current through Register Vol. 48, No. 6, June 28, 2024
The Facility shall develop, implement, and maintain an effective, ongoing, facility-wide, data-driven quality assessment and performance improvement program. The Facility's governing body shall ensure that the program reflects the complexity of the Facility's organization and services; involves all Facility departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-16 - Minimum Standards for Licensing Hospitals and Institutional General Infirmaries › Sec2 61-16.400 - POLICIES AND PROCEDURES › Section 61-16.403 - Security. (II)

Current through Register Vol. 48, No. 6, June 28, 2024
In order to ensure the safety and well-being of all patients, staff, and visitors, the Facility's governing body (or its designee) shall conduct an annual risk assessment to identify potential areas or situations that may cause harm or where an incident may occur. Based upon the findings of that assessment, the Facility's governing body (or its designee) shall develop and implement a plan to provide for the appropriate level of security necessary.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-16 - Minimum Standards for Licensing Hospitals and Institutional General Infirmaries › Sec2 61-16.500 - STAFF AND TRAINING › Section 61-16.501 - General

Current through Register Vol. 48, No. 6, June 28, 2024
Every facility shall be organized, equipped, staffed and administered in order that adequate care may be provided for each person admitted.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-16 - Minimum Standards for Licensing Hospitals and Institutional General Infirmaries › Sec2 61-16.500 - STAFF AND TRAINING › Section 61-16.502 - Control. (II)

Current through Register Vol. 48, No. 6, June 28, 2024
The Facility shall have a governing body which is effective in carrying out its responsibilities for the conduct of the Facility. In the absence of an organized governing body, the Facility shall maintain written documentation that identifies the individual or individuals that are legally responsible for the conduct of the Facility's operations.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-16 - Minimum Standards for Licensing Hospitals and Institutional General Infirmaries › Sec2 61-16.500 - STAFF AND TRAINING › Section 61-16.503 - Chief Executive Officer

Current through Register Vol. 48, No. 6, June 28, 2024
The Facility shall appoint a Chief Executive Officer (CEO) who is responsible for the administration of the facility and all its branches and departments. The Facility shall notify the Department of any change in the Chief Executive Officer in writing within twenty-four (24) hours and shall provide the Department the name of the newly-appointed, interim CEO, or other person who is in charge of and responsible for administration of the facility, and the effective date of the appointment.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-16 - Minimum Standards for Licensing Hospitals and Institutional General Infirmaries › Sec2 61-16.500 - STAFF AND TRAINING › Section 61-16.505 - Nursing Services. (II)

Current through Register Vol. 48, No. 6, June 28, 2024
A. Nursing Services shall be organized and staffed at all times to provide safe, appropriate, and individualized care to each patient. The authority, responsibility and function of all patient care providers shall be clearly defined by written Facility policy and position descriptions.
B. The Facility must have an organized nursing service that provides 24-hour nursing services. This service must be under the direction of a Chief Nursing Officer (CNO), who is a registered nurse. A registered nurse shall be designated in writing to act in the absence of the CNO.
C. There shall be a sufficient number of duly licensed registered nurses on duty at all times provide nursing care to meet the needs of the patient population for all areas where nursing care is provided. A registered nurse must be on duty at all times.
D. Facility personnel may be employed to assist the registered nurse in providing nursing care. Licensed practical nurses and all other workers who are employed by a facility in nursing services shall be assigned based on their education, training, and competency.
E. All personnel who render nursing care services in the Facility shall be under the supervision of nursing leadership and shall be subject to all policies and procedures of the facility.
F. All nurses employed in a nursing role in a facility shall be currently licensed to practice in South Carolina or pursuant to the Nurse Licensure Compact.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-16 - Minimum Standards for Licensing Hospitals and Institutional General Infirmaries › Sec2 61-16.500 - STAFF AND TRAINING › Section 61-16.506 - Employees (II)

Current through Register Vol. 48, No. 6, June 28, 2024
A. The Chief Executive Officer shall designate an individual to conduct Human Resources Management within the organization. That individual, and other individuals as needed, shall have responsibility for hiring, personnel management, compensation and benefits, and maintenance of accurate and complete personnel records.
B. The facility shall develop and make available to the employee a written job description for each type of job in the facility. Each job description shall include a written description of the education, experience, license, certification, or other qualifications required for the position.
C. The Facility personnel records shall contain, at a minimum, the following:
1. For clinical personnel, information sufficient to verify the employee's qualifications for the job for which that individual is employed. That information includes, but is not limited to: employee's education, professional certification or licensure status, other training, experience and indication of clinical competence.
2. For non-clinical personnel, information regarding the employee's education, training, experience and professional competence sufficient to verify the employee's qualifications for the job for which that individual is employed. Such information shall be kept current.
3. Records of pre-employment health assessment as described in Section 602.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-16 - Minimum Standards for Licensing Hospitals and Institutional General Infirmaries › Sec2 61-16.500 - STAFF AND TRAINING › Section 61-16.507 - Job Orientation and In-Service Training

Current through Register Vol. 48, No. 6, June 28, 2024
A. Orientation of all new personnel shall be structured to educate them about the organization and environment of the facility, the employees' specific duties and responsibilities, and patients' needs.
B. In-service training programs shall be planned and provided for all personnel to ensure and maintain their understanding of their duties and responsibilities. Records shall be maintained to reflect program content and individuals attending.
C. Either as a component of orientation or in a separate session, all new employees who will have contact with patients or who will handle or potentially handle blood, body fluids or tissue must receive general education regarding infection prevention and control within the hospital.
D. Each employee shall be familiar with the Facility's emergency disaster plan and fire response plans. The hospital must ensure at orientation and annually thereafter that employees receive training regarding emergency management, including surge policies and procedures and events that would indicate a need to implement surge policies and procedures, and fire response.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-16 - Minimum Standards for Licensing Hospitals and Institutional General Infirmaries › Sec2 61-16.500 - STAFF AND TRAINING › Section 61-16.508 - Plans and Training for Fires and Other Internal Emergencies

Current through Register Vol. 48, No. 6, June 28, 2024
A. Each facility
				shall develop, in coordination with its supporting fire department and/or
				disaster preparedness agency, suitable written plans for actions to be taken in
				the event of fire and other emergencies. All employees shall be made familiar
				with these plans and instructed as to required actions.
B. Each employee shall receive instructions
				covering fire protection training.
C. A fire drill shall be conducted for each
				shift at least quarterly. Records of drills shall be maintained to report the
				date, time, shift and a description and evaluation of the drill.
D. Drills shall be designed and conducted to:
1. Assure that all personnel are capable of
				performing assigned tasks or duties;
2. Assure that all personnel know the
				location, use and how to operate firefighting equipment;
3. Assure that all personnel are thoroughly
				familiar with the fire plan; and
4.
				Evaluate the effectiveness of plans and personnel.