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NORTH CAROLINA REGISTER Volume 20, Issue 23 Pages 2007 - 2152 June 1, 2006 This issue contains documents officially filed through May 10, 2006. Office of Administrative Hearings Rules Division 424 North Blount Street (27601) 6714 Mail Service Center Raleigh, NC 27699-6714 (919) 733-2678 FAX (919) 733-3462 Julian Mann III, Director Camille Winston, Deputy Director Molly Masich, Director of APA Services Dana Sholes, Publications Coordinator Julie Brincefield, Editorial Assistant Felicia Williams, Editorial Assistant Lisa Johnson, RRC Administrative Assistant IN THIS ISSUE I. IN ADDITION Secretary of State – Notice.............................................. 2007 Brownfields Property – Imperial Partners....................... 2008 Brownfields Property – Town of Forest City.................. 2009 II. PROPOSED RULES Health and Human Services Facility Services .......................................................... 2010 - 2034 Medical Care Commission .......................................... 2034 – 2035 Labor Mine and Quarry Bureau............................................. 2036 - 2037 III. APPROVED RULES.................................................... 2038 – 2102 Community Colleges Community Colleges, Board of Environment and Natural Resources Radiation Protection Commission Water Treatment Facility Operators Certification Board Wildlife Resources Commission Health and Human Services Child Care Commission Medical Assistance Medical Care Commission Social Services Commission Labor Elevator & Amusement Device Bureau Licensing Boards and Commissions Auctioneer Licensing Board General Contractors, Board of Medical Board Nursing Board Plumbing, Heating & Fire Sprinkler Contractors Veterinary Medical Board Revenue The Department IV. RULES REVIEW COMMISSION.............................. 2103 - 2123 V. CONTESTED CASE DECISIONS Index to ALJ Decisions................................................... 2124 - 2133 Text of Selected Decisions 05 DHR 1077 .............................................................. 2134 - 2141 05 DHR 1392 .............................................................. 2142 - 2152 For the CUMULATIVE INDEX to the NC Register go to: http://reports.oah.state.nc.us/cumulativeIndex.pl North Carolina Register is published semi-monthly for $195 per year by the Office of Administrative Hearings, 424 North Blount Street, Raleigh, NC 27601. North Carolina Register (ISSN 15200604) to mail at Periodicals Rates is paid at Raleigh, NC. POSTMASTER: Send Address changes to the North Carolina Register, 6714 Mail Service Center, Raleigh, NC 27699-6714. NORTH CAROLINA ADMINISTRATIVE CODE CLASSIFICATION SYSTEM The North Carolina Administrative Code (NCAC) has four major classifications of rules. Three of these, titles, chapters, and sections are mandatory. The major classification of the NCAC is the title. Each major department in the North Carolina executive branch of government has been assigned a title number. Titles are further broken down into chapters which shall be numerical in order. Subchapters are optional classifications to be used by agencies when appropriate. NCAC TITLES TITLE 21 LICENSING BOARDS TITLE 24 INDEPENDENT AGENCIES 1 ADMINISTRATION 2 AGRICULTURE & CONSUMER SERVICES 3 AUDITOR 4 COMMERCE 5 CORRECTION 6 COUNCIL OF STATE 7 CULTURAL RESOURCES 8 ELECTIONS 9 GOVERNOR 10A HEALTH AND HUMAN SERVICES 11 INSURANCE 12 JUSTICE 13 LABOR 14A CRIME CONTROL & PUBLIC SAFETY 15A ENVIRONMENT &NATURAL RESOURCES 16 PUBLIC EDUCATION 17 REVENUE 18 SECRETARY OF STATE 19A TRANSPORTATION 20 TREASURER 21* OCCUPATIONAL LICENSING BOARDS 22 ADMINISTRATIVE PROCEDURES (REPEALED) 23 COMMUNITY COLLEGES 24* INDEPENDENT AGENCIES 25 STATE PERSONNEL 26 ADMINISTRATIVE HEARINGS 27 NC STATE BAR 28 JUVENILE JUSTICE AND DELINQUENCY PREVENTION 1 Acupuncture 2 Architecture 3 Athletic Trainer Examiners 4 Auctioneers 6 Barber Examiners 8 Certified Public Accountant Examiners 10 Chiropractic Examiners 11 Employee Assistance Professionals 12 General Contractors 14 Cosmetic Art Examiners 16 Dental Examiners 17 Dietetics/Nutrition 18 Electrical Contractors 19 Electrolysis 20 Foresters 21 Geologists 22 Hearing Aid Dealers and Fitters 25 Interpreter/Transliterator 26 Landscape Architects 28 Landscape Contractors 29 Locksmith Licensing 30 Massage & Bodywork Therapy 31 Marital and Family Therapy 32 Medical Examiners 33 Midwifery Joint Committee 34 Funeral Service 36 Nursing 37 Nursing Home Administrators 38 Occupational Therapists 40 Opticians 42 Optometry 44 Osteopathic Examination (Repealed) 45 Pastoral Counselors, Fee-Based Practicing 46 Pharmacy 48 Physical Therapy Examiners 50 Plumbing, Heating & Fire Sprinkler Contractors 52 Podiatry Examiners 53 Professional Counselors 54 Psychology 56 Professional Engineers & Land Surveyors 57 Real Estate Appraisal 58 Real Estate Commission 60 Refrigeration Examiners 61 Respiratory Care 62 Sanitarian Examiners 63 Social Work Certification 64 Speech & Language Pathologists & Audiologists 65 Therapeutic Recreation Certification 66 Veterinary Medical 68 Substance Abuse Professionals 69 Soil Scientists 1 Housing Finance 2 Agricultural Finance Authority 3 Safety & Health Review Board 4 Reserved 5 State Health Plan Purchasing Alliance Board Note: Title 21 contains the chapters of the various occupational licensing boards and Title 24 contains the chapters of independent agencies. NORTH CAROLINA REGISTER Publication Schedule for January 2006 – December 2006 FILING DEADLINES NOTICE OF TEXT PERMANENT RULE TEMPORARY RULES Volume & issue number Issue date Last day for filing Earliest date for public hearing End of required comment period Deadline to submit to RRC for review at next meeting Earliest Eff. Date of Permanent Rule Delayed Eff. Date of Permanent Rule (first legislative day of the next regular session) 270th day from publication in the Register 20:13 01/03/06 12/08/05 01/18/06 03/06/06 03/20/06 05/01/06 05/09/06 09/30/06 20:14 01/17/06 12/21/05 02/01/06 03/20/06 04/20/06 06/01/06 01/07 10/14/06 20:15 02/01/06 01/10/06 02/16/06 04/03/06 04/20/06 06/01/06 01/07 10/29/06 20:16 02/15/06 01/25/06 03/02/06 04/17/06 04/20/06 06/01/06 01/07 11/12/06 20:17 03/01/06 02/08/06 03/16/06 05/01/06 05/22/06 07/01/06 01/07 11/26/06 20:18 03/15/06 02/22/06 03/30/06 05/15/06 05/22/06 07/01/06 01/07 12/10/06 20:19 04/03/06 03/13/06 04/18/06 06/02/06 06/20/06 08/01/06 01/07 12/29/06 20:20 04/17/06 03/24/06 05/02/06 06/16/06 06/20/06 08/01/06 01/07 01/12/07 20:21 05/01/06 04/07/06 05/16/06 06/30/06 07/20/06 09/01/06 01/07 01/26/07 20:22 05/15/06 04/24/06 05/30/06 07/14/06 07/20/06 09/01/06 01/07 02/09/07 20:23 06/01/06 05/10/06 06/16/06 07/31/06 08/21/06 10/01/06 01/07 02/26/07 20:24 06/15/06 05/24/06 06/30/06 08/14/06 08/21/06 10/01/06 01/07 03/12/07 21:01 07/03/06 06/12/06 07/18/06 09/01/06 09/20/06 11/01/06 01/07 03/30/07 21:02 07/17/06 06/23/06 08/01/06 09/15/06 09/20/06 11/01/06 01/07 04/13/07 21:03 08/01/06 07/11/06 08/16/06 10/02/06 10/20/06 12/01/06 01/07 04/28/07 21:04 08/15/06 07/25/06 08/30/06 10/16/06 10/20/06 12/01/06 01/07 05/12/07 21:05 09/01/06 08/11/06 09/16/06 10/31/06 11/20/06 01/01/07 01/07 05/29/07 21:06 09/15/06 08/24/06 09/30/06 11/14/06 11/20/06 01/01/07 01/07 06/12/07 21:07 10/02/06 09/11/06 10/17/06 12/01/06 12/20/06 02/01/07 05/08 06/29/07 21:08 10/16/06 09/25/06 10/31/06 12/15/06 12/20/06 02/01/07 05/08 07/13/07 21:09 11/01/06 10/11/06 11/16/06 01/01/07 01/22/07 03/01/07 05/08 07/29/07 21:10 11/15/06 10/24/06 11/30/06 01/15/07 01/22/07 03/01/07 05/08 08/12/07 21:11 12/01/06 11/07/06 12/16/06 01/30/07 02/20/07 04/01/07 05/08 08/28/07 21:12 12/15/06 11/22/06 12/30/06 02/13/07 02/20/07 04/01/07 05/08 09/11/07 EXPLANATION OF THE PUBLICATION SCHEDULE This Publication Schedule is prepared by the Office of Administrative Hearings as a public service and the computation of time periods are not to be deemed binding or controlling. Time is computed according to 26 NCAC 2C .0302 and the Rules of Civil Procedure, Rule 6. GENERAL The North Carolina Register shall be published twice a month and contains the following information submitted for publication by a state agency: (1) temporary rules; (2) notices of rule-making proceedings; (3) text of proposed rules; (4) text of permanent rules approved by the Rules Review Commission; (5) notices of receipt of a petition for municipal incorporation, as required by G.S. 120-165; (6) Executive Orders of the Governor; (7) final decision letters from the U.S. Attorney General concerning changes in laws affecting voting in a jurisdiction subject of Section 5 of the Voting Rights Act of 1965, as required by G.S. 120-30.9H; (8) orders of the Tax Review Board issued under G.S. 105-241.2; and (9) other information the Codifier of Rules determines to be helpful to the public. COMPUTING TIME: In computing time in the schedule, the day of publication of the North Carolina Register is not included. The last day of the period so computed is included, unless it is a Saturday, Sunday, or State holiday, in which event the period runs until the preceding day which is not a Saturday, Sunday, or State holiday. FILING DEADLINES ISSUE DATE: The Register is published on the first and fifteen of each month if the first or fifteenth of the month is not a Saturday, Sunday, or State holiday for employees mandated by the State Personnel Commission. If the first or fifteenth of any month is a Saturday, Sunday, or a holiday for State employees, the North Carolina Register issue for that day will be published on the day of that month after the first or fifteenth that is not a Saturday, Sunday, or holiday for State employees. LAST DAY FOR FILING: The last day for filing for any issue is 15 days before the issue date excluding Saturdays, Sundays, and holidays for State employees. NOTICE OF TEXT EARLIEST DATE FOR PUBLIC HEARING: The hearing date shall be at least 15 days after the date a notice of the hearing is published. END OF REQUIRED COMMENT PERIOD An agency shall accept comments on the text of a proposed rule for at least 60 days after the text is published or until the date of any public hearings held on the proposed rule, whichever is longer. DEADLINE TO SUBMIT TO THE RULES REVIEW COMMISSION: The Commission shall review a rule submitted to it on or before the twentieth of a month by the last day of the next month. FIRST LEGISLATIVE DAY OF THE NEXT REGULAR SESSION OF THE GENERAL ASSEMBLY: This date is the first legislative day of the next regular session of the General Assembly following approval of the rule by the Rules Review Commission. See G.S. 150B- 21.3, Effective date of rules. IN ADDITION 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2007 Note from the Codifier: This Section contains public notices that are required to be published in the Register or have been approved by the Codifier of Rules for publication. DEPARTMENT OF THE SECRETARY OF STATE NOTICE OF PUBLIC HEARING Pursuant to G.S. 150B-21.2(e), the Department will conduct a public hearing regarding proposed administrative rules concerning regulation of lobbying filed with the Office of Administrative Hearings on April 24, 2006, cited as 18 NCAC 12 .0101-.0117 and 18 NCAC 13 .0101-.0116. The public hearing will be held as follows: Date: Monday, June 19, 2006 Time: 9:00 a.m. Location: Department of Commerce's Utilities Commission Hearing Room (#2115), Dobbs Building (enter on Mall side of Dobbs Building) Comments may be submitted to: Joal Broun, Secretary of State's Office, 2 South Salisbury Street, Raleigh, NC 27601-2903 or P.O. Box 29622, Raleigh, NC, telephone (919) 807-2005, fax (919) 807-2010, e-mail jbroun@sosnc.com Comment period ends: July 14, 2006 IN ADDITION 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2008 SUMMARY OF NOTICE OF INTENT TO REDEVELOP A BROWNFIELDS PROPERTY Imperial Centre Partners, LP Pursuant to N.C.G.S. § 130A-310.34, Imperial Centre Partners, LP has filed with the North Carolina Department of Environment and Natural Resources ("DENR") a Notice of Intent to Redevelop a Brownfields Property ("Property") in Rocky Mount, Nash County, North Carolina. The Property consists of the former sites of the Imperial Tobacco Plant at 270 Gay Street and the former Braswell Memorial Library at 344 Falls Road and comprises approximately 3.6 acres. Environmental contamination exists on the Property in the soil and groundwater. Imperial Centre Partners, LP has committed itself to redevelopment of the Property for no use other than as a cultural arts center for the City of Rocky Mount. The Notice of Intent to Redevelop a Brownfields Property includes: (1) a proposed Brownfields Agreement between DENR and Imperial Centre Partners, LP, which in turn includes (a) a map showing the location of the Property, (b) a description of the contaminants involved and their concentrations in the media of the Property, (c) the above-stated description of the intended future use of the Property, and (d) proposed investigation and remediation; and (2) a proposed Notice of Brownfields Property prepared in accordance with G.S. 130A-310.35. The full Notice of Intent to Redevelop a Brownfields Property may be reviewed at the Braswell Library, 727 North Grace Street, Rocky Mount by contacting Phillip Whitford at (252) 442-1951, extension 255 or by email at PWhitford@Braswell- Library.org; or at NC Brownfields Program, 401 Oberlin Rd., Suite 150, Raleigh, NC 27605 by contacting Shirley Liggins at that address, at shirley.liggins@ncmail.net, or at (919) 508-8411, where DENR will provide auxiliary aids and services for persons with disabilities who wish to review the documents. Written public comments may be submitted to DENR within 60 days after the date this Notice is published in a newspaper of general circulation serving the area in which the brownfields property is located, or in the North Carolina Register, whichever is later. Written requests for a public meeting may be submitted to DENR within 30 days after the period for written public comments begins. Thus, if Imperial Centre Partners, LP, as it plans, publishes this Summary in the North Carolina Register after it publishes the Summary in a newspaper of general circulation serving the area in which the brownfields property is located, and if it effects publication of this Summary in the North Carolina Register on the date it expects to do so, the periods for submitting written requests for a public meeting regarding this project and for submitting written public comments will commence on June 2, 2006. All such comments and requests should be addressed as follows: Mr. Bruce Nicholson Brownfields Program Manager Division of Waste Management NC Department of Environment and Natural Resources 401 Oberlin Road, Suite 150 Raleigh, North Carolina 27605 IN ADDITION 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2009 SUMMARY OF NOTICE OF INTENT TO REDEVELOP A BROWNFIELDS PROPERTY Town of Forest City Pursuant to N.C.G.S. § 130A-310.34, the Town of Forest City has filed with the North Carolina Department of Environment and Natural Resources ("DENR") a Notice of Intent to Redevelop a Brownfields Property ("Property") in Forest City, Rutherford County, North Carolina. The Property, known as the former Cone Mill site, consists of 9.2 acres and is located at 186 Mill Street; 108, 110 and 112 East Main Street; 125 Depot Street and 139 Depot Street. Environmental contamination exists on the Property in the soil and groundwater. The Town of Forest City has committed itself to limit redevelopment of the Property to commercial, retail, office, residential, storage, hotel, public gathering and open space uses. The Notice of Intent to Redevelop a Brownfields Property includes: (1) a proposed Brownfields Agreement between DENR and RiverLink, Incorporated, which in turn includes (a) a map showing the location of the Property, (b) a description of the contaminants involved and their concentrations in the media of the Property, (c) the above-stated description of the intended future use of the Property, and (d) proposed investigation and remediation; and (2) a proposed Notice of Brownfields Property prepared in accordance with G.S. 130A-310.35. During the 60-day public comment period, the full Notice of Intent to Redevelop a Brownfields Property may be reviewed at Forest City's utility bill payments desk, 128 North Powell Street, Forest City, NC 28043 by contacting Danielle Withrow at that address or at (828) 248-5200; at Forest City's public library, 240 East Main Street, Forest City, NC 28043 by contacting Mary Sandra Costner at that address or at (828) 248-5224; or at the offices of the N.C. Brownfields Program, 401 Oberlin Rd., Suite 150, Raleigh, NC 27605 by contacting Shirley Liggins at that address (where DENR will provide auxiliary aids and services for persons with disabilities who wish to review the documents), at shirley.liggins@ncmail.net, or at (919) 508-8411. Written public comments may be submitted to DENR within 60 days after the date this Notice is published in a newspaper of general circulation serving the area in which the brownfields property is located, or in the North Carolina Register, whichever is later. Written requests for a public meeting may be submitted to DENR within 30 days after the period for written public comments begins. Thus, if the Town of Forest City, as it plans, publishes this Summary in the North Carolina Register after it publishes the Summary in a newspaper of general circulation serving the area in which the brownfields property is located, and if it effects publication of this Summary in the North Carolina Register on the date it expects to do so, the periods for submitting written requests for a public meeting regarding this project and for submitting written public comments will commence on June 2, 2006. All such comments and requests should be addressed as follows: Mr. Bruce Nicholson Brownfields Program Manager Division of Waste Management NC Department of Environment and Natural Resources 401 Oberlin Road, Suite 150 Raleigh, North Carolina 27605 PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2010 Note from the Codifier: The notices published in this Section of the NC Register include the text of proposed rules. The agency must accept comments on the proposed rule(s) for at least 60 days from the publication date, or until the public hearing, or a later date if specified in the notice by the agency. If the agency adopts a rule that differs substantially from a prior published notice, the agency must publish the text of the proposed different rule and accept comment on the proposed different rule for 60 days. Statutory reference: G.S. 150B-21.2. TITLE 10A – DEPARTMENT OF HEALTH AND HUMAN SERVICES Notice is hereby given in accordance with G.S. 150B-21.2 that the Division of Facility Services intends to adopt the rules cited as 10A NCAC 14C .3901-.3906, .4001-.4005; amend the rules cited as 10A NCAC 14C .0203, .1501-.1505, .1601-.1603, .1605, .1901, .2101, .2103, .2203, .2502-.2503, .2505, .2602, .2701- .2705, .2801, .3702-.3704; and repeal the rules cited as 10A NCAC 14C .2806, .3501-.3502, .3504-.3505. Proposed Effective Date: October 1, 2006 Public Hearing: Date: July 27, 2006 Time: 10:00 a.m. Location: Room 201, Council Building, 701 Barbour Drive, Dorothea Dix Campus, Raleigh, North Carolina, 27603 Reason for Proposed Action: Several subject matters are addressed in the State Medical Facilities Plan (SMFP). Changes to existing Certificate of Need rules are required to ensure consistency with the SMFP that became effective January 1, 2006. Procedure by which a person can object to the agency on a proposed rule: An individual may object to the agency on the proposed rule by submitting written comments on the proposed rule. They may also object by attending the public hearing and personally voice their objections during that time. Comments may be submitted to: Elizabeth K. Brown, NC Division of Facility Services, 2701 Mail Service Center, Raleigh, North Carolina, 27699-2701, phone (919) 855-3751; fax (919) 733-2757; email elizabeth.brown@ncmail.net Comment period ends: July 31, 2006 Procedure for Subjecting a Proposed Rule to Legislative Review: If an objection is not resolved prior to the adoption of the rule, a person may also submit written objections to the Rules Review Commission. If the Rules Review Commission receives written and signed objections in accordance with G.S. 150B-21.3(b2) from 10 or more persons clearly requesting review by the legislature and the Rules Review Commission approves the rule, the rule will become effective as provided in G.S. 150B-21.3(b1). The Commission will receive written objections until 5:00 p.m. on the day following the day the Commission approves the rule. The Commission will receive those objections by mail, delivery service, hand delivery, or facsimile transmission. If you have any further questions concerning the submission of objections to the Commission, please call a Commission staff attorney at 919-733-2721. Fiscal Impact: State Local Substantive (>$3,000,000) None CHAPTER 14 – DIRECTOR, DIVISION OF FACILITY SERVICES SUBCHAPTER 14C – CERTIFICATE OF NEED REGULATIONS SECTION .2000 – CRITERIA AND STANDARDS FOR HOME HEALTH SERVICES 10A NCAC 14C .0203 FILING APPLICATIONS (a) An application shall not be reviewed by the agency until it is filed in accordance with this Rule. (b) An original and a copy of the application shall be file-stamped as received by the agency no later than 5:30 p.m. on the 15th day of the month preceding the scheduled review period. In instances when the 15th of the month falls on a weekend or holiday, the filing deadline is 5:30 p.m. on the next business day. An application shall not be included in a scheduled review if it is not received by the agency by this deadline. Each applicant shall transmit, with the application, a fee to be determined according to the following formula: (1) With each application proposing the addition of a sixth bed to an existing or approved five bed intermediate care facility for the mentally retarded, the proponent shall transmit a fee in the amount of two thousand dollars ($2,000). (2) With each application, other than those referenced in Subparagraph (b)(1) of this Rule, proposing no capital expenditure or a capital expenditure of up to, but not including, one million dollars ($1,000,000), the proponent shall transmit a fee in the amount of three thousand five hundred dollars ($3,500). (3) With each application, other than those referenced in Subparagraph (b)(1) of this Rule, proposing a capital expenditure of one million dollars ($1,000,000) or greater, the proponent shall transmit a fee in the amount of three thousand five hundred dollars ($3,500), plus an additional fee equal to .003 of the amount of the proposed capital expenditure in excess of one million dollars ($1,000,000). The additional fee shall be rounded to the nearest PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2011 whole dollar. In no case shall the total fee exceed seventeen thousand five hundred dollars ($17,500). (c) After an application is filed, the agency shall determine whether it is complete for review. An application shall not be considered complete if: (1) the requisite fee has not been received by the agency; or (2) a signed original and copy of the application have not been submitted to the agency on the appropriate application form. (d) If the agency determines the application is not complete for review, it shall mail notice of such determination to the applicant within five business days after the application is filed and shall specify what is necessary to complete the application. If the agency determines the application is complete, it shall mail notice of such determination to the applicant prior to the beginning of the applicable review period. (e) Information requested by the agency to complete the application must be received by the agency no later than 5:30 p.m. on the last working day before the first day of the scheduled review period. The review of an application shall commence in the next applicable review period that commences after the application has been determined to be complete. Authority G.S. 131E-177; 131E-182. SECTION .1500 - CRITERIA AND STANDARDS FOR HOSPICES 10A NCAC 14C .1501 DEFINITIONS The following definitions shall apply to all rules in this Section: (1) "Bereavement counseling" means counseling provided to a hospice patient's family or significant others to assist them in dealing with issues of grief and loss. (2) "Caregiver" means the person whom the patient designates to provide the patient with emotional support, physical care, or both. (3) "Care plan" means a plan as defined in 10A NCAC 13K .0102 of the Hospice Licensing Rules. (4) "Continuous care" means care as defined in 42 CFR 418.204, the Hospice Medicare Regulations. (5) "Home-like" means furnishings of a hospice inpatient facility or a hospice residential care facility as defined in 10A NCAC 13K .1110 or .1204 of the Hospice Licensing Rules. (6)(5) "Homemaker services" means services provided to assist the patient with personal care, maintenance of a safe and healthy environment and implementation of the patient's care plan. (7)(6) "Hospice" means any coordinated program of home care as defined in G.S. 131E-176(13a). (8)(7) "Hospice inpatient facility" means a facility as defined in G.S. 131E-176(13b). (9) "Hospice residential care facility" means a facility as defined in G.S. 131E-176(13c). (10) "Hospice service area" means for residential care facilities, the county in which the hospice residential care facility will be located and the contiguous counties for which the hospice residential care facility will provide services. (11)(8) "Hospice services" means services as defined in G.S. 131E-201(5b). (12)(9) "Hospice staff" means personnel as defined in 10A NCAC 13K .0102 of the Hospice Licensing Rules. (13)(10) "Interdisciplinary team" means personnel as defined in G.S. 131E-201(6). (14)(11) "Palliative care" means treatment as defined in G.S. 131E-201(8). (15)(12) "Respite care" means care provided as defined in 42 CFR 418.98. Authority G.S. 131E-177(1). 10A NCAC 14C .1502 INFORMATION REQUIRED OF APPLICANT (a) An applicant proposing to develop a hospice shall complete the application form for Hospice Services. An applicant proposing to develop hospice inpatient facility beds or hospice residential care facility beds shall complete the application form for Hospice Inpatient and Hospice Residential Care Services. (b) An applicant proposing to develop a hospice, hospice inpatient facility beds, or hospice residential care facility beds shall provide the following information: (1) the annual unduplicated number of hospice patients projected to be served in each of the first two years following completion of the project and the methodology and assumptions used to make the projections; (2) the projected number of duplicated hospice patients to be served by quarter for the first 24 months following completion of the project and the methodology and assumptions used to make the projections; (3) the projected number of patient care days, by level of care (i.e., routine home care, respite care, and inpatient care), by quarter, to be provided in each of the first two years of operation following completion of the project and the methodology and assumptions used to make the projections shall be clearly stated; (4) the projected number of hours of continuous care to be provided in each of the first two years of operation following completion of the project and the methodology and assumptions used to make these projections; (5) the projected average annual cost per hour of continuous care for each of the first two operating years following completion of the project and the methodology and assumptions used to make the projections; (6) the projected average annual cost per patient care day, by level of care (i.e., routine home care, respite care, and inpatient care), for each of the first two operating years following PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2012 completion of the project and the methodology and assumptions used to project the average annual cost; and (7) documentation of attempts made to establish working relationships with sources of referrals to the hospice services and copies of proposed agreements for the provision of inpatient care. (c) An applicant proposing to develop a hospice shall commit that it shall comply with all certification requirements for participation in the Medicare program within one year after issuance of the certificate of need. (d) An applicant proposing to develop hospice inpatient or hospice residential care facility beds shall also provide the following information: (1) a description of the means by which hospice services shall be provided in the patient's own home; (2) copies of the proposed contractual agreements, with a licensed hospice or a licensed home care agency with a hospice designation on its license, for the provision of hospice services in the patient's own home; (3) a copy of the admission policies, including the criteria that shall be used to select persons for admission and to assure that terminally ill patients are served in their own homes as long as possible; and (4) documentation that a home-like setting shall be provided in the facility. Authority G.S. 131E-177(1); 131E-183. 10A NCAC 14C .1503 PERFORMANCE STANDARDS (a) An applicant proposing to develop hospice inpatient facility beds or hospice residential care facility beds shall demonstrate that: (1) the average occupancy rate of the licensed hospice beds in the facility is projected to be at least 50% for the last six months of the first operating year following completion of the project; (2) the average occupancy rate for the licensed hospice beds in the facility is projected to be at least 65% for the second operating year following completion of the project; and (3) if the application is submitted to address the need for a hospice residential care facility, each existing facility which is located in the hospice service area and which has licensed hospice beds of the type proposed by the applicant attained an occupancy rate of at least 65% for the 12 month period reported on that facility's most recent Licensure Renewal Application Form. (b) An applicant proposing to add beds to an existing hospice inpatient facility or hospice residential care facility shall document that the average occupancy of the licensed hospice inpatient and hospice residential care facility beds in its existing facility was at least 65% for the nine months immediately preceding the submittal of the proposal. (c) An applicant proposing to develop a hospice shall demonstrate that no less than 80% of the total combined number of days of hospice care furnished to Medicaid and Medicare patients will be provided in the patients' residences in accordance with 42 CFR 418.302(f)(2). Authority G.S. 131E-177(1). 10A NCAC 14C .1504 SUPPORT SERVICES (a) An applicant proposing to develop a hospice, hospice inpatient facility beds, or hospice residential care facility beds shall demonstrate that the following core services will be provided directly by the applicant to the patient and the patient's family or significant others: (1) nursing services; (2) social work services; (3) counseling services including dietary, spiritual, and family counseling; (4) bereavement counseling services; (5) volunteer services; (6) physician services; and (7) medical supplies. (b) An applicant shall demonstrate that the nursing services listed in Paragraph (a) of this Rule will be available 24 hours a day, seven days a week. (c) An applicant proposing to develop a hospice, hospice inpatient facility beds, or hospice residential care facility beds shall provide documentation that the following services, when ordered by the attending physician and specified in the care plan, shall either be provided directly by the hospice or provided through a contract arranged by the hospice: (1) hospice inpatient care provided in a licensed hospice inpatient facility bed, licensed acute care bed or licensed nursing facility bed, (2) physical therapy, (3) occupational therapy, (4) speech therapy, (5) home health aide services, (6) medical equipment, (7) respite care, (8) homemaker services, and (9) continuous care. (d) An applicant proposing to develop a hospice inpatient facility or a hospice residential care facility shall provide documentation that pharmaceutical services will be provided directly by the facility or by contract. (e)(d) For each of the services listed in Paragraphs Paragraph (c) and (d) of this Rule which are proposed to be provided by contract, the applicant shall provide a copy of a letter from the proposed provider which expresses their interest in working with the proposed facility. Authority G.S. 131E-177(1); 131E-183. 10A NCAC 14C .1505 STAFFING AND STAFF TRAINING (a) An applicant proposing to develop a hospice, hospice inpatient facility beds, or hospice residential care facility beds shall document that staffing for hospice services will be provided in a manner consistent with G.S. 131E, Article 10. PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2013 (b) The applicant shall demonstrate that: (1) the staffing pattern will be consistent with licensure requirements as specified in 10A NCAC 13K, Hospice Licensing Rules; (2) training for all hospice staff and volunteers will meet the requirements as specified in 10A NCAC 13K .0400, Hospice Licensing Rules; (3) a volunteer program will be established and operated in accordance with 10A NCAC 13K .0400 and .0500 and 42 CFR 418.70; (4) an interdisciplinary team will be established which includes, at a minimum, a physician, a licensed nurse, a social worker, a clergy member, and a trained hospice volunteer, as specified in G.S. 131E-201; (5) a qualified health care professional will coordinate the hospice interdisciplinary team to assure implementation of an integrated care plan and the continuous assessment of the needs of the patient and the patient's family or significant others; (6) a written care plan will be developed by the attending physician, the medical director or physician designee, and the interdisciplinary team before care is provided to a patient and the patient's family or significant others; (7) meetings of the interdisciplinary care team and other appropriate personnel will be held on a frequent and regular basis, at least once every two weeks, for the purpose of care plan review and staff support; and (8) each interdisciplinary team member will be provided orientation, training, and continuing education programs appropriate to their responsibilities and to the maintenance of skills necessary for the physical care of the patient and the psychosocial and spiritual care of the patient and the patient's family or significant others. Authority G.S. 131E-177(1). SECTION .1600 – CRITERIA AND STANDARDS FOR CARDIAC CATHETERIZATION EQUIPMENT AND CARDIAC ANGIOPLASTY EQUIPMENT 10A NCAC 14C .1601 DEFINITIONS The following definitions shall apply to all rules in this Section: (1) "Approved" means the equipment was not in operation prior to the beginning of the review period and had been issued a certificate of need. (2) "Capacity" of an item of cardiac catheterization equipment or cardiac angioplasty equipment means 1500 diagnostic-equivalent procedures per year. One therapeutic cardiac catheterization procedure is valued at 1.75 diagnostic-equivalent procedures. One cardiac catheterization procedure performed on a patient age 14 or under is valued at two diagnostic-equivalent procedures. All other procedures are valued at one diagnostic-equivalent procedure. (3) "Cardiac angioplasty equipment" shall have the same meaning as defined in G.S. 131E-176(2e). (4)(3) "Cardiac catheterization equipment" shall have the same meaning as defined in G.S. 131E-176(2f). (5)(4) "Cardiac catheterization procedure", for the purpose of determining utilization in a certificate of need review, means a single episode of diagnostic or therapeutic catheterization which occurs during one visit to a cardiac catheterization room, whereby a flexible tube is inserted into the patient's body and advanced into the heart chambers to perform a hemodynamic or angiographic examination or therapeutic intervention of the left or right heart chamber, or coronary arteries. A cardiac catheterization procedure does not include a simple right heart catheterization for monitoring purposes as might be done in an electrophysiology laboratory, pulmonary angiography procedure, cardiac pacing through a right electrode catheter, temporary pacemaker insertion, or procedures performed in dedicated angiography or electrophysiology rooms. (6)(5) "Cardiac catheterization room" means a room or a mobile unit in which there is cardiac catheterization or cardiac angioplasty equipment for the performance of cardiac catheterization procedures. Dedicated angiography rooms and electrophysiology rooms are not cardiac catheterization rooms. (7)(6) "Cardiac catheterization service area" means a geographical area defined by the applicant, which has boundaries that are not farther than 90 road miles from the facility, if the facility has a comprehensive cardiac services program; and not farther than 45 road miles from the facility if the facility performs only diagnostic cardiac catheterization procedures; except that the cardiac catheterization service area of an academic medical center teaching hospital designated in 10A NCAC 14B shall not be limited to 90 road miles. (8)(7) "Cardiac catheterization services" means the provision of diagnostic cardiac catheterization procedures or therapeutic cardiac catheterization procedures performed utilizing cardiac catheterization equipment or cardiac angioplasty equipment in a cardiac catheterization room. (9)(8) "Comprehensive cardiac services program" means a cardiac services program which provides the full range of clinical services associated with the treatment of cardiovascular PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2014 disease including community outreach, emergency treatment of cardiovascular illnesses, non-invasive diagnostic imaging modalities, diagnostic and therapeutic cardiac catheterization procedures, open heart surgery and cardiac rehabilitation services. Community outreach and cardiac rehabilitation services shall be provided by the applicant or through arrangements with other agencies and facilities located in the same city. All other components of a comprehensive cardiac services program shall be provided within a single facility. (10)(9) "Diagnostic cardiac catheterization procedure", for the purpose of determining utilization in a certificate of need review, means a cardiac catheterization procedure performed for the purpose of detecting and identifying defects or diseases in the coronary arteries or veins of the heart, or abnormalities in the heart structure, but not the pulmonary artery. (11)(10) "Electrophysiology procedure" means a diagnostic or therapeutic procedure performed to study the electrical conduction activity of the heart and characterization of atrial ventricular arrhythmias. (12)(11) "Existing" means the equipment was in operation prior to the beginning of the review period. (13)(12) "High-risk patient" means a person with reduced life expectancy because of left main or multi-vessel coronary artery disease, often with impaired left ventricular function and with other characteristics as referenced in the American College of Cardiology/American Heart Association Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories (1991) American College of Cardiology/ Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards (June 2001) report. (14)(13) "Mobile equipment" means cardiac angioplasty equipment or cardiac catheterization equipment and transporting equipment which is moved to provide services at two or more host facilities. (15)(14) "Percutaneous transluminal coronary angioplasty (PTCA)" is one type of therapeutic cardiac catheterization procedure used to treat coronary artery disease in which a balloon-tipped catheter is placed in the diseased artery and then inflated to compress the plaque blocking the artery. (16)(15) "Primary cardiac catheterization service area" means a geographical area defined by the applicant, which has boundaries that are not farther than 45 road miles from the facility, if the facility has a comprehensive cardiac services program; and not farther than 23 road miles from the facility if the facility performs only diagnostic cardiac catheterization procedures; except that the primary cardiac catheterization service area of an academic medical center teaching hospital designated in 10A NCAC 14B shall not be limited to 45 road miles. (17)(16) "Therapeutic cardiac catheterization procedure", for the purpose of determining utilization in a certificate of need review, means a cardiac catheterization procedure performed for the purpose of treating or resolving anatomical or physiological conditions which have been determined to exist in the heart or coronary arteries or veins of the heart, but not the pulmonary artery. Authority G.S. 131E-177(1); 131E-183. 10A NCAC 14C .1602 INFORMATION REQUIRED OF APPLICANT (a) An applicant that proposes to acquire cardiac catheterization or cardiac angioplasty equipment shall use the acute care facility/medical equipment application form. (b) The applicant shall provide the following additional information based on the population residing within the applicant's proposed cardiac catheterization service area: (1) the projected annual number of cardiac catheterization procedures, by CPT or ICD-9-CM codes, classified by adult diagnostic, adult therapeutic and pediatric cardiac catheterization procedure, to be performed in the facility during each of the first three years of operation following completion of the proposed project, including the methodology and assumptions used for these projections; (2) documentation of the applicant's experience in treating cardiovascular patients at the facility during the past 12 months, including: (A) the number of patients receiving stress tests; (B) the number of patients receiving intravenous thrombolytic therapies; (C) the number of patients presenting in the Emergency Room or admitted to the hospital with suspected or diagnosed acute myocardial infarction; (D) the number of patients referred to other facilities for cardiac catheterization procedures or open heart surgery procedures, by type of procedure; and (E) the number of diagnostic and therapeutic cardiac catheterization procedures performed during the twelve month period reflected in the PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2015 most recent licensure form on file with the Division of Facility Services; (3) the number of cardiac catheterization patients, classified by adult diagnostic, adult therapeutic and pediatric, from the proposed cardiac catheterization service area that the applicant proposes to serve by patient's county of residence in each of the first three years of operation, including the methodology and assumptions used for these projections; (4) documentation of the applicant's projected sources of patient referrals that are located in the proposed cardiac catheterization service area, including letters from the referral sources that demonstrate their intent to refer patients to the applicant for cardiac catheterization procedures; (5) evidence of the applicant's capability to communicate with emergency transportation agencies and with an established comprehensive cardiac services program; (6) the number and composition of cardiac catheterization teams available to the applicant; (7) documentation of the applicant's in-service training or continuing education programs for cardiac catheterization team members; (8) a written agreement with a comprehensive cardiac services program that specifies the arrangements for referral and transfer of patients seen by the applicant and that includes a process to alleviate the need for duplication in cardiac catheterization procedures; (9) a written description of patient selection criteria including referral arrangements for high-risk patients; (10) a copy of the contractual arrangements for the acquisition of the proposed cardiac catheterization equipment or cardiac angioplasty equipment including itemization of the cost of the equipment; and (11) documentation that the cardiac catheterization equipment and cardiac angioplasty equipment and the procedures for operation of the equipment are designed and developed based on the American College of Cardiology/American Heart Association Guidelines for Cardiac Catheterization Laboratories (1991) American College of Cardiology/ Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards (June 2001) report. Authority G.S. 131E-177(1); 131E-183. 10A NCAC 14C .1603 PERFORMANCE STANDARDS (a) An applicant shall demonstrate that the project is capable of meeting the following standards: (1) each proposed item of cardiac catheterization equipment or cardiac angioplasty equipment, including mobile equipment but excluding shared fixed cardiac catheterization or angioplasty equipment, shall be utilized at an annual rate of at least 60 percent of capacity excluding procedures not defined as cardiac catheterization procedures in 10A NCAC 14C .1601(5), measured during the fourth quarter of the third year following completion of the project; (2) if the applicant proposes to perform therapeutic cardiac catheterization procedures, each of the applicant's therapeutic cardiac catheterization teams shall be performing at an annual rate of at least 100 therapeutic cardiac catheterization procedures, during the third year of operation following completion of the project; (3) if the applicant proposes to perform diagnostic cardiac catheterization procedures, each diagnostic cardiac catheterization team shall be performing at an annual rate of at least 200 diagnostic-equivalent cardiac catheterization procedures by the end of the third year following completion of the project; (4) at least 50 percent of the projected cardiac catheterization procedures shall be performed on patients residing within the primary cardiac catheterization service area; (b) An applicant proposing to acquire mobile cardiac catheterization or mobile cardiac angioplasty equipment shall: (1) demonstrate that each existing item of cardiac catheterization equipment and cardiac angioplasty equipment, excluding mobile equipment, located in the proposed primary cardiac catheterization service area of each host facility shall have been operated at a level of at least 80 percent of capacity during the 12 month period reflected in the most recent licensure form on file with the Division of Facility Services; (2) demonstrate that the utilization of each existing or approved item of cardiac catheterization equipment and cardiac angioplasty equipment, excluding mobile equipment, located in the proposed primary cardiac catheterization service area of each host facility shall not be expected to fall below 60 percent of capacity due to the acquisition of the proposed cardiac catheterization, cardiac angioplasty, or mobile cardiac catheterization equipment; (3) demonstrate that each item of existing mobile equipment operating in the proposed primary cardiac catheterization service area of each host facility shall have been performing at least an average of four diagnostic-equivalent cardiac catheterization procedures per day per site in the proposed cardiac catheterization PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2016 service area in the 12 month period preceding the submittal of the application; (4) demonstrate that each item of existing or approved mobile equipment to be operating in the proposed primary cardiac catheterization service area of each host facility shall be performing at least an average of four diagnostic-equivalent cardiac catheterization procedures per day per site in the proposed cardiac catheterization service area in the applicant's third year of operation; and (5) provide documentation of all assumptions and data used in the development of the projections required in this Rule. (c) An applicant proposing to acquire cardiac catheterization or cardiac angioplasty equipment excluding shared fixed and mobile cardiac catheterization or cardiac angioplasty equipment shall: (1) demonstrate that its existing items of cardiac catheterization and cardiac angioplasty equipment, except mobile equipment, located in the proposed cardiac catheterization service area operated at an average of at least 80% of capacity during the twelve month period reflected in the most recent licensure renewal application form on file with the Division of Facility Services; (2) demonstrate that its existing items of cardiac catheterization equipment or cardiac angioplasty equipment, except mobile equipment, shall be utilized at an average annual rate of at least 60 percent of capacity, measured during the fourth quarter of the third year following completion of the project; and (3) provide documentation of all assumptions and data used in the development of the projections required in this Rule. (d) An applicant proposing to acquire shared fixed cardiac catheterization or cardiac angioplasty equipment as defined in the applicable State Medical Facilities Plan shall: (1) demonstrate that each proposed item of shared fixed cardiac catheterization or cardiac angioplasty equipment shall perform a combined total of at least 225 cardiac catheterization and angiography procedures during the fourth quarter of the third year following completion of the project; and (2) provide documentation of all assumptions and data used in the development of the projections required in this Rule. (e) If the applicant proposes to perform cardiac catheterization procedures on patients age 14 and under, the applicant shall demonstrate that it meets the following additional criteria: (1) the facility has the capability to perform diagnostic and therapeutic cardiac catheterization procedures and open heart surgery services on patients age 14 and under; and (2) the proposed project shall be performing at an annual rate of at least 100 cardiac catheterization procedures on patients age 14 or under during the fourth quarter of the third year following initiation of the proposed cardiac catheterization procedures for patients age 14 and under. Authority G.S. 131E-177(1); 131E-183(b). 10A NCAC 14C .1605 STAFFING AND STAFF TRAINING (a) The applicant shall provide documentation to demonstrate that the following staffing requirements shall be met: (1) one physician licensed to practice medicine in North Carolina who has been designated to serve as director of the cardiac catheterization service and who has all of the following special credentials: (A) board-certified in internal medicine, pediatrics or radiology; (B) subspecialty training in cardiology, pediatric cardiology, or cardiovascular radiology; and (C) current clinical experience in performing physiologic procedures, angiographic procedures, or both; (2) at least one specialized team to perform cardiac catheterizations, composed of at least the following professional and technical personnel: (A) one physician licensed to practice medicine in North Carolina with evidence of training and current experience specifically in cardiovascular disease and radiation sciences; (B) one nurse with training and current experience specifically in critical care of cardiac patients, cardiovascular medication, and catheterization equipment; and (C) at least three two technicians with training specifically in cardiac care who are capable of performing the duties of a radiologic technologist, cardiopulmonary technician, monitoring and recording technician, and darkroom technician. (b) The applicant shall provide documentation to demonstrate that the following staff training shall be provided for members of cardiac catheterization teams: (1) certification in cardiopulmonary resuscitation and advanced cardiac life support; and (2) an organized program of staff education and training which is integral to the cardiac services program and ensures improvements in technique and the proper training of new personnel. Authority G.S. 131E-177(1); 131E-183(b). PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2017 SECTION .1900 – CRITERIA AND STANDARDS FOR RADIATION THERAPY EQUIPMENT 10A NCAC 14C .1901 DEFINITIONS These definitions shall apply to all rules in this Section: (1) "Approved linear accelerator" means a linear accelerator which was not operational prior to the beginning of the review period. (2) "Complex Radiation treatment" is equal to 1.0 ESTV and means: treatment on three or more sites on the body; use of special techniques such as tangential fields with wedges, rotational or arc techniques; or use of custom blocking. (3) "Equivalent Simple Treatment Visit [ESTV]" means one basic unit of radiation therapy which normally requires up to fifteen (15) minutes for the uncomplicated set-up and treatment of a patient on a megavoltage teletherapy unit including the time necessary for portal filming. (4) "Existing linear accelerator" means a linear accelerator in operation prior to the beginning of the review period. (5) "Intermediate Radiation treatment" means treatment on two separate sites on the body, three or more fields to a single treatment site or use of multiple blocking and is equal to 1.0 ESTV. (6) "Linear accelerator" means MRT equipment which is used to deliver a beam of electrons or photons in the treatment of cancer patients. shall have the same meaning as defined in G.S. 131E-176(14g). (7) "Linear accelerator service area" means a single or multi-county area as used in the development of the need determination in the applicable State Medical Facilities Plan. (8) "Megavoltage unit" means MRT equipment which provides a form of teletherapy that involves the delivery of energy greater than, or equivalent to, one million volts by the emission of x-rays, gamma rays, electrons, or other radiation. (9) "Megavoltage radiation therapy (MRT)" means the use of ionizing radiation in excess of one million electron volts in the treatment of cancer. (10) "MRT equipment" means a machine or energy source used to provide megavoltage radiation therapy including linear accelerators and other particle accelerators. (11) "Radiation therapy equipment" means medical equipment which is used to provide radiation therapy services. (12) "Radiation therapy services" means those services which involve the delivery of controlled and monitored doses of radiation to a defined volume of tumor bearing tissue within a patient. Radiation may be delivered to the tumor region by the use of radioactive implants or by beams of ionizing radiation or it may be delivered to the tumor region systemically. (13) "Radiation therapy service area" means a single or multi-county area as used in the development of the need determination in the applicable State Medical Facilities Plan. (14) "Simple Radiation treatment" means treatment on a single site on the body, single treatment field or parallel opposed fields with no more than simple blocks and is equal to 1 ESTV. (15) "Simulator" means a machine that reproduces the geometric relationships of the MRT equipment to the patient. shall have the same meaning as defined in G.S. 131E-176(24b). (16) "Special technique" means radiation therapy treatments that may require increased time for each patient visit including: (a) total body irradiation (photons or electrons) which equals 2.5 ESTVs; (b) hemi-body irradiation which equals 2.0 ESTVs; (c) intraoperative radiation therapy which equals 10.0 ESTVs; (d) neutron and proton radiation therapy which equals 2.0 ESTVs; (e) intensity modulated radiation treatment (IMRT) which equals 2.0 ESTVs; 1.0 ESTV; (f) limb salvage irradiation at lengthened SSD which equals 1.0 ESTV; (g) additional field check radiographs which equals .50 ESTV; (h) stereotactic radiosurgery treatment management with linear accelerator or gamma knife which equals 3.0. ESTVs; and (i) pediatric patient under anesthesia which equals 1.5 ESTVs. Authority G.S. 131E-177(1); 131E-183(b). SECTION .2100 – CRITERIA AND STANDARDS FOR SURGICAL SERVICES AND OPERATING ROOMS 10A NCAC 14C .2101 DEFINITIONS The following definitions shall apply to all rules in this Section: (1) "Ambulatory surgical facility" means a facility as defined in G.S. 131E-176(1b). (2) "Operating room" means an inpatient operating room, an outpatient or ambulatory surgical operating room, or a shared operating room, or an endoscopy procedure room in a licensed health service facility. room. (3) "Ambulatory surgical program" means a program as defined in G.S. 131E-176(1c). (4) "Existing operating rooms" means those operating rooms in ambulatory surgical facilities and hospitals which were reported in PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2018 the License Application for Ambulatory Surgical Facilities and Programs and in Part III of Hospital Licensure Renewal Application Form submitted to the Licensure Section of the Division of Facility Services and which were licensed and certified prior to the beginning of the review period. (5) "Approved operating rooms" means those operating rooms that were approved for a certificate of need by the Certificate of Need Section prior to the date on which the applicant's proposed project was submitted to the Agency but that have not been licensed. and certified. licensed. (6) "Multispecialty ambulatory surgical program" means a program as defined in G.S. 131E- 176(15a). (7) "Outpatient or ambulatory surgical operating room" means an operating room used solely for the performance of surgical procedures which require local, regional or general anesthesia and a period of post-operative observation of less than 24 hours. (8) "Service area" means the Operating Room Service Area as defined in the applicable State Medical Facilities Plan. (9) "Shared operating room" means an operating room that is used for the performance of both ambulatory and inpatient surgical procedures. (10) "Specialty area" means an area of medical practice in which there is an approved medical specialty certificate issued by a member board of the American Board of Medical Specialties and includes, but is not limited to the following: gynecology, otolaryngology, plastic surgery, general surgery, ophthalmology, urology, orthopedics, and oral surgery. (11) "Specialty ambulatory surgical program" means a program as defined in G.S. 131E- 176(24c). (12) "Surgical case" means an individual who receives one or more surgical procedures in an operating room during a single operative encounter. Authority G.S. 131E-177(1); 131E-183(b). 10A NCAC 14C .2103 PERFORMANCE STANDARDS (a) In projecting utilization, the existing, approved and proposed operating rooms shall be considered to be available for use five days per week and 52 weeks a year. (b) A proposal to establish a new ambulatory surgical facility, to increase the number of operating rooms (excluding dedicated C-section operating rooms), to convert a specialty ambulatory surgical program to a multispecialty ambulatory surgical program or to add a specialty to a specialty ambulatory surgical program shall not be approved unless the applicant documents that the average number of surgical cases per operating room to be performed in each facility owned by the applicant in the proposed service area, is reasonably projected to be at least 2.4 surgical cases per day for each inpatient operating room, room (excluding dedicated open-heart and dedicated C-Section operating rooms), 4.8 surgical cases per day for each outpatient or ambulatory surgical operating room, 7.2 cases per day for each endoscopy procedure room, and 3.2 surgical cases per day for each shared operating room during the third year of operation following completion of the project. (c) A proposal to develop an additional operating room to be used as a dedicated C-section operating room shall not be approved unless the applicant documents that the average number of surgical cases per operating room to be performed in each facility owned by the applicant in the proposed service area, is reasonably projected to be at least 2.4 surgical cases per day for each inpatient operating room (excluding dedicated open-heart and dedicated C-section operating rooms), 4.8 surgical cases per day for each outpatient or ambulatory surgical operating room and 3.2 surgical cases per day for each shared operating room during the third year of operation following completion of the project. (d) An applicant proposing to convert a specialty ambulatory surgical program to a multispecialty ambulatory surgical program or to add a specialty to a specialty ambulatory surgical program shall provide documentation to show that each existing ambulatory surgery program in the service area that performs ambulatory surgery in the same specialty area as proposed in the application is currently operating at 4.8 surgical cases per day for each outpatient or ambulatory surgical operating room, 7.2 gastrointestinal endoscopy cases per day for each gastrointestinal endoscopy procedure room, and 3.2 surgical cases per day for each shared operating room. (e) An applicant proposing to convert a specialty ambulatory surgical program to a multispecialty ambulatory surgical program or to add a specialty to a specialty ambulatory surgical program shall provide documentation to show that each existing and approved ambulatory surgery program in the service area that performs ambulatory surgery in the same specialty areas as proposed in the application is reasonably projected to be operating at 4.8 surgical cases per day for each outpatient or ambulatory surgical operating room, 7.2 gastrointestinal endoscopy cases per day for each gastrointestinal endoscopy procedure room, and 3.2 surgical cases per day for each shared surgical operating room prior to the completion of the proposed project. (f) The applicant shall document the assumptions and provide data supporting the methodology used for each projection in this Rule. Authority G.S. 131E-177; 131E-183(b). SECTION .2200 – CRITERIA AND STANDARDS FOR END-STAGE RENAL DISEASE SERVICES 10A NCAC 14C .2203 PERFORMANCE STANDARDS (a) An applicant proposing to establish a new End Stage Renal Disease facility shall document the need for at least 10 stations based on utilization of 3.2 patients per station per week as of the end of the first operating year of the facility. facility, with the exception that the performance standard shall be waived for a need in the State Medical Facilities Plan that is based on an adjusted need determination. PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2019 (b) An applicant proposing to increase the number of dialysis stations in an existing End Stage Renal Disease facility shall document the need for the additional stations based on utilization of 3.2 patients per station per week as of the end of the first operating year of the additional stations with the exception that the performance standard shall be waived for a need in the State Medical Facilities Plan that is based on an adjusted need determination. stations. (c) An applicant shall provide all assumptions, including the specific methodology by which patient utilization is projected. Authority G.S. 131E-177(1); 131E-183(b). SECTION .2500 – CRITERIA AND STANDARDS FOR SUBSTANCE ABUSE/CHEMICAL DEPENDENCY TREATMENT BEDS 10A NCAC 14C .2502 INFORMATION REQUIRED OF APPLICANT (a) An applicant proposing to establish new intensive treatment beds or detoxification beds shall project resident origin by percentage by county of residence. All assumptions and the methodology for projecting occupancy shall be clearly stated. (b) An applicant proposing to establish new intensive treatment beds or detoxification beds shall project an occupancy level for the entire facility for the first eight calendar quarters following the completion of the proposed project, including the average length of stay. All assumptions and the methodology for projecting occupancy shall be clearly stated. (c) If the applicant is an existing chemical dependency treatment facility, the applicant shall document the percentage of patients discharged from the facility that are readmitted to the facility at a later date. (d) An applicant shall document that the following items are currently available or will be made available following completion of the project: (1) admission criteria for clinical admissions to the facility or unit, including procedure for accepting emergency admissions; (2) client evaluation procedures, including preliminary evaluation and establishment of an individual treatment plan; (3) procedures for referral and follow-up of clients to necessary outside services; (4) procedures for involvement of family in counseling process; (5) provision of an aftercare plan; and (6) quality assurance/utilization review plan. (e) An applicant proposing to establish new detoxification beds shall identify the location of each referral source for follow-up outpatient, residential and rehabilitation services located in the proposed service area for clients who have completed detoxification. (f)(e) An applicant shall document the attempts made to establish working relationships with the health care providers and others that are anticipated to refer clients to the proposed intensive treatment and detoxification beds. (g)(f) An applicant shall provide copies of any current or proposed contracts or agreements or letters of intent to develop contracts or agreements for the provision of any services to the clients served in the chemical dependency treatment facility. (h) An applicant shall identify the Area Authority that will serve as the Single Portal of Entry/Exit for the facility. (i)(g) An applicant shall document the provisions that will be made to obtain services for patients with a dual diagnosis of chemical dependency and psychiatric problems. (j)(h) An applicant proposing to establish new intensive treatment beds or detoxification beds shall specify the primary site on which the facility will be located. If such site is neither owned by nor under option by the applicant, the applicant shall provide a written commitment to diligently pursue acquiring the site if and when a certificate of need application is approved, shall specify at least one alternate site on which the facility could be located should acquisition efforts relative to the primary site ultimately fail, and shall demonstrate that the primary site and alternate sites are available for acquisition. (k)(i) An applicant proposing to establish new intensive treatment beds or detoxification beds shall document that the services will be provided in a physical environment that conforms with the requirements in 10A NCAC 27G .0300 which are incorporated by reference including all subsequent amendments. Authority G.S. 131E-177(1); 131E-183. 10A NCAC 14C .2503 PERFORMANCE STANDARDS (a) An applicant shall not be approved unless the overall occupancy, over the nine months immediately preceding the submittal of the application, of the total number of intensive treatment beds and detoxification beds within the facility in which the beds are to be located, located except in facilities with only detoxification beds, has been: (1) 75 percent for facilities with a total of 1-15 intensive treatment beds and detoxification beds; or (2) 85 percent for facilities with a total of 16 or more intensive treatment beds and detoxification beds. (b) An applicant shall not be approved unless the overall occupancy of the total number of intensive treatment beds and detoxification beds to be operated in the facility is projected, projected except in facilities with only detoxification beds, by the fourth quarter of the third year of operation following completion of the project, to be: (1) 75 percent for facilities with a total of 1-15 intensive treatment beds and detoxification beds; or (2) 85 percent for facilities with a total of 16 or more intensive treatment beds and detoxification beds. (c) An applicant proposing to add detoxification beds to an existing facility that includes only detoxification beds shall not be approved unless the overall occupancy of the total number of detoxification beds in the facility has been at least 75 percent for the nine months immediately preceding the submittal of the application. (d) An applicant proposing to establish a new detoxification facility or add detoxification beds to an existing facility that includes only detoxification beds shall demonstrate that the PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2020 overall occupancy of the total number of detoxification beds in the facility is reasonably projected to be 75 percent by the fourth quarter of the third year of operation following completion of the project. (e)(c)The applicant shall document the specific methodology and assumptions by which occupancies are projected, including the average length of stay and anticipated recidivism rate. Authority G.S. 131E-177(1); 131E-183(b). 10A NCAC 14C .2505 STAFFING AND STAFF TRAINING (a) An applicant proposing to establish new intensive treatment beds or detoxification beds shall document that clinical staff members will be: (1) currently licensed or certified by the appropriate state licensure or certification boards; or (2) supervised by staff who are licensed or certified by the appropriate state licensure or certification boards. (b) An applicant proposing to establish new intensive treatment beds or detoxification beds shall document that the staffing pattern in the facility is consistent with the staffing requirements contained in 10A NCAC 27G .3102, .3202, or .3402, which are incorporated by reference including all subsequent amendments. Authority G.S. 131E-177(1); 131E-183. SECTION .2600 – CRITERIA AND STANDARDS FOR PSYCHIATRIC BEDS 10A NCAC 14C .2602 INFORMATION REQUIRED OF APPLICANT (a) An applicant proposing to establish new psychiatric beds shall project resident origin by percentage by county of residence. All assumptions and the methodology for projecting occupancy shall be clearly stated. (b) An applicant proposing to establish new psychiatric beds shall project an occupancy level for the entire facility for the first eight calendar quarters following the completion of the proposed project, including average length of stay. All assumptions and the methodology for projecting occupancy shall be clearly stated. (c) The applicant shall provide documentation of the percentage of patients discharged from the facility that are readmitted to the facility at a later date. (d) An applicant proposing to establish new psychiatric beds shall describe the general treatment plan that is anticipated to be used by the facility and the support services to be provided, including provisions that will be made to obtain services for patients with a dual diagnosis of psychiatric and chemical dependency problems. (e) The applicant shall document the attempts made to establish working relationships with the health care providers and others that are anticipated to refer clients to the proposed psychiatric beds. (f) The applicant shall provide copies of any current or proposed contracts or agreements or letters of intent to develop contracts or agreements for the provision of any services to the clients served in the psychiatric facility. (g) The application shall identify the Area Authority that will serve as the Single Portal of Entry/Exit for the facility. (h)(g) The applicant shall document that the following items are currently available or will be made available following completion of the project: (1) admission criteria for clinical admissions to the facility or unit; (2) emergency screening services for the targeted population which shall include services for handling emergencies on a 24-hour basis or through formalized transfer agreements; (3) client evaluation procedures, including preliminary evaluation and establishment of an individual treatment plan; (4) procedures for referral and follow-up of clients to necessary outside services; (5) procedures for involvement of family in counseling process; (6) comprehensive services which shall include individual, group and family therapy; medication therapy; and activities therapy including recreation; (7) educational components if the application is for child or adolescent beds; (8) provision of an aftercare plan; and (9) quality assurance/utilization review plan. (i)(h) An applicant proposing to establish new psychiatric beds shall specify the primary site on which the facility will be located. If such site is neither owned by nor under option by the applicant, the applicant shall provide a written commitment to diligently pursue acquiring the site if and when a certificate of need application is approved, shall specify at least one alternate site on which the facility could be located should acquisition efforts relative to the primary site ultimately fail, and shall demonstrate that the primary site and alternate sites are available for acquisition. (j)(i) An applicant proposing to establish new psychiatric beds shall provide documentation to show that the services will be provided in a physical environment that conforms with the requirements in 10A NCAC 27G .0300. Authority G.S. 131E-177(1); 131E-183. SECTION .2700 - CRITERIA AND STANDARDS FOR MAGNETIC RESONANCE IMAGING SCANNER 10A NCAC 14C .2701 DEFINITIONS The following definitions shall apply to all rules in this Section: (1) "Approved MRI scanner" means an MRI scanner which was not operational prior to the beginning of the review period but which had been issued a certificate of need. (2) "Capacity of fixed MRI scanner" means 100% of the procedure volume that the MRI scanner is capable of completing in a year, given perfect scheduling, no machine or room downtime, no cancellations, no patient transportation problems, no staffing or PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2021 physician delays and no MRI procedures outside the norm. Annual capacity of a fixed MRI scanner is 6,864 weighted MRI procedures, which assumes two weighted MRI procedures are performed per hour and the scanner is operated 66 hours per week, 52 weeks per year. (3) "Capacity of mobile MRI scanner" means 100% of the procedure volume that the MRI scanner is capable of completing in a year, given perfect scheduling, no machine or room downtime, no cancellations, no patient transportation problems, no staffing or physician delays and no MRI procedures outside the norm. Annual capacity of a mobile MRI scanner is 4,160 weighted MRI procedures, which assumes two weighted MRI procedures are performed per hour and the scanner is operated 40 hours per week, 52 weeks per year. (4) "Dedicated breast MRI scanner" means an MRI scanner that is configured to perform only breast MRI procedures and is not capable of performing other types of non-breast MRI procedures. (4)(5) "Existing MRI scanner" means an MRI scanner in operation prior to the beginning of the review period. (6) "Extremity MRI scanner" means an MRI scanner that is utilized for the imaging of extremities and is of open design with a field of view no greater than 25 centimeters. (5)(7) "Fixed MRI scanner" means an MRI scanner that is not a mobile MRI scanner. (6)(8) "Magnetic Resonance Imaging" (MRI) means a non-invasive diagnostic modality in which electronic equipment is used to create tomographic images of body structure. The MRI scanner exposes the target area to nonionizing magnetic energy and radio frequency fields, focusing on the nuclei of atoms such as hydrogen in the body tissue. Response of selected nuclei to this stimulus is translated into images for evaluation by the physician. (7)(9) "Magnetic resonance imaging scanner" (MRI Scanner) is defined in G.S. 131E-176(14e). (8)(10) "Mobile MRI region" means either the eastern part of the State which includes the counties in Health Service Areas IV, V and VI, VI (Eastern Mobile MRI Region), or the western part of the State which includes the counties in Health Service Areas I, II, and III. III (Western Mobile MRI Region). The counties in each Health Service Area are identified in Appendix A of the State Medical Facilities Plan. (9)(11) "Mobile MRI scanner" means an MRI scanner and transporting equipment which is moved at least weekly to provide services at two or more host facilities. (10)(12) "MRI procedure" means a single discrete MRI study of one patient. (11)(13) "MRI service area" means the Magnetic Resonance Imaging Planning Areas, as defined in the applicable State Medical Facilities Plan, except for proposed new mobile MRI scanners for which the service area is a mobile MRI region. (12)(14) "MRI study" means one or more scans relative to a single diagnosis or symptom. (13) "Pediatric MRI patient" means a patient requiring an MRI scan who is under the age of 12 years or who is a special needs patient and is under the age of 21 years. (14)(15) "Related entity" means the parent company of the applicant, a subsidiary company of the applicant (i.e., the applicant owns 50% or more of another company), a joint venture in which the applicant is a member, or a company that shares common ownership with the applicant (i.e., the applicant and another company are owned by some of the same persons). (15) "Special Needs patient" means a patient who has cerebral palsy, encephalomyelopathy, central nervous system injuries, genetic and metabolic disorders, autism, and mental retardation. (16) "Temporary MRI scanner" means a an MRI scanner that the Certificate of Need Section has approved to be temporarily located in North Carolina at a facility that holds a certificate of need for a new fixed MRI scanner, but which is not operational because the project is not yet complete. (17) "Weighted MRI procedures" means MRI procedures which are adjusted to account for the length of time to complete the procedure, based on the following weights: one outpatient MRI procedure without contrast or sedation is valued at 1.0 weighted MRI procedure, one outpatient MRI procedure with contrast or sedation is valued at 1.4 weighted MRI procedures, one inpatient MRI procedure without contrast or sedation is valued at 1.4 weighted MRI procedures; and one inpatient MRI procedure with contrast or sedation is valued at 1.8 weighted MRI procedures. (18) "Weighted breast MRI procedures" means MRI procedures which are performed on a dedicated breast MRI scanner and are adjusted to account for the length of time to complete the procedure, based on the following weights: one diagnostic breast MRI procedure is valued at 1.0 weighted MRI procedure (based on an average of 60 minutes per procedure), one MRI-guided breast needle localization MRI procedure is valued at 1.1 weighted MRI procedure (based on an average of 66 minutes per procedure), and one MRI-guided breast PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2022 biopsy procedure is valued at 1.6 weighted MRI procedures (based on an average of 96 minutes per procedure). Authority G.S. 131E-177(1); 131E-183(b). 10A NCAC 14C .2702 INFORMATION REQUIRED OF APPLICANT (a) An applicant proposing to acquire an MRI scanner, including a mobile MRI scanner, shall use the Acute Care Facility/Medical Equipment application form. (b) Except for proposals to acquire mobile MRI scanners that serve two or more host facilities, both the applicant and the person billing the patients for the MRI service shall be named as co-applicants in the application form. (c) An applicant proposing to acquire a magnetic resonance imaging scanner, including a mobile MRI scanner, shall provide the following information: (1) documentation that the proposed fixed MRI scanner, excluding fixed extremity and breast MRI scanners, shall be available and staffed for use at least 66 hours per week; (2) documentation that the proposed mobile MRI scanner shall be available and staffed for use at least 40 hours per week; (3) documentation that the proposed fixed extremity or dedicated breast MRI scanner shall be available and staffed for use at least 40 hours per week; (3)(4) the average charge to the patient, regardless of who bills the patient, for each of the 20 most frequent MRI procedures to be performed for each of the first three years of operation after completion of the project and a description of items included in the charge; if the professional fee is included in the charge, provide the dollar amount for the professional fee; (4)(5) if the proposed MRI service will be provided pursuant to a service agreement, the dollar amount of the service contract fee billed by the applicant to the contracting party for each of the first three years of operation; (5)(6) letters from physicians indicating their intent to refer patients to the proposed magnetic resonance imaging scanner and their estimate of the number of patients proposed to be referred per year; year, which is based on the physicians' historical number of referrals; (7) for each location at which the applicant or a related entity will provide MRI services, utilizing existing, approved, or proposed MRI scanners, projections of the annual number of unweighted MRI procedures to be performed for each of the four types of MRI procedures, as identified in the SMFP, for each of the first three years of operation after completion of the project; (6)(8) for each location at which the service will be provided, applicant or a related entity will provide services, utilizing existing, approved, or proposed MRI scanners, projections of the annual number of weighted MRI procedures to be performed for each of the four types of weighted MRI procedures, as identified in the SMFP, for each of the first three years of operation after completion of the project; (7)(9) a detailed description of the methodology and assumptions used to project the number of unweighted weighted MRI procedures to be performed; performed at each location, including the number of contrast versus non-contrast procedures, sedation versus non-sedation procedures, and inpatient versus outpatient procedures; (8)(10) documentation to support each assumption used in projecting the number of procedures to be performed; a detailed description of the methodology and assumptions used to project the number of weighted MRI procedures to be performed at each location; (9)(11) for each existing fixed or mobile MRI scanner owned by the applicant or a related entity and operated in North Carolina in the month the application is submitted, the vendor, tesla strength, serial number or vehicle identification number, CON project identification number, physical location for fixed MRI scanners, and host sites for mobile MRI scanners; (10)(12) for each approved fixed or mobile MRI scanner to be owned by the applicant or a related entity and approved to be operated in North Carolina, the proposed vendor, proposed tesla strength, CON project identification number, physical location for fixed MRI scanners, and host sites for mobile MRI scanners; (11)(13) if proposing to acquire a mobile MRI scanner, an explanation of the basis for selection of the proposed host sites if the host sites are not located in MRI service areas that lack a fixed MRI scanner; and (14) identity of the accreditation authority the applicant proposes to use. (d) An applicant proposing to acquire a mobile MRI scanner shall provide copies of letters of intent from, and proposed contracts with, all of the proposed host facilities of the new MRI scanner. (e) An applicant proposing to acquire a dedicated fixed breast MRI scanner shall: shall demonstrate that: (1) provide a copy of a contract or working agreement with a radiologist or practice group that has experience interpreting images and is trained to interpret images produced by an MRI scanner configured exclusively for mammographic studies; (2) document that the applicant performed mammograms without interruption in the PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2023 provision of the service during the last year; and (3) document that the applicant's existing mammography equipment is in compliance with the U.S. Food and Drug Administration Mammography Quality Standards Act. (1) it has an existing and ongoing working relationship with a specialized breast–imaging radiologist or radiology practice group that has experience interpreting breast images provided by mammography, ultrasound, and MRI scanner equipment, and that is trained to interpret images produced by a MRI scanner configured exclusively for mammographic studies; (2) for the last 12 months it has performed the following services, without interruption in the provision of these services: breast MRI procedures on a fixed MRI scanner with a breast coil, mammograms, breast ultrasound procedures, breast needle core biopsies, breast cyst aspirations, and pre-surgical breast needle localizations; (3) its existing mammography equipment, breast ultrasound equipment, and the proposed dedicated breast MRI scanner is in compliance with the federal Mammography Quality Standards Act; (4) it is part of an existing healthcare system that provides comprehensive cancer care, including radiation oncology, medical oncology, surgical oncology and an established breast cancer treatment program that is based in the geographic area proposed to be served by the applicant; and (5) it has an existing relationship with an established collaborative team for the treatment of breast cancer that includes, radiologists, pathologists, radiation oncologists, hematologists/oncologists, surgeons, obstetricians/gynecologists, and primary care providers. (f) An applicant proposing to acquire a dedicated fixed pediatric an extremity MRI scanner, pursuant to a need determination in the State Medical Facilities Plan for a demonstration project, shall: (1) provide a copy of a contract or working agreement with two pediatric radiologists qualified as described in 10A NCAC 14C .2705(f)(1); (2) provide a copy of the facility's emergency plan for pediatric and special needs patients that outline all emergency procedures including acute care transfers and a copy of a contract with an ambulance service for transportation during any emergencies; (3) commit that the proposed MRI scanner shall be used exclusively to perform procedures on pediatric MRI patients; (4) provide a description of the scope of the research studies that shall be conducted to develop protocols related to MRI scanning of pediatric MRI patients; which includes special needs patients, and (5) commit to prepare an annual report, to be submitted to the Medical Facilities Planning Section and the Certificate of Need Section, which shall include the protocols for scanning pediatric MRI patients and the annual volume of weighted MRI procedures performed, by type. (1) provide a detailed description of the scope of the research studies that shall be conducted to demonstrate the convenience, cost effectiveness and improved access resulting from utilization of extremity MRI scanning; (2) provide projections of estimated cost savings from utilization of an extremity MRI scanner based on comparison of "total dollars received per procedure" performed on the proposed scanner in comparison to "total dollars received per procedure" performed on whole body scanners; (3) provide projections of estimated cost savings to the patient from utilization of an extremity MRI scanner; (4) commit to prepare an annual report at the end of each of the first three operating years, to be submitted to the Medical Facilities Planning Section and the Certificate of Need Section, that shall include: (A) a detailed description of the research studies completed, (B) a description of the results of the studies, (C) the cost per procedure to the patient and billing entity, (D) the cost savings to the patient attributed to utilization of an extremity MRI scanner, (E) an analysis of "total dollars received per procedure" performed on the extremity MRI scanner in comparison to "total dollars received per procedure" performed on whole body scanners; and (F) the annual volume of unweighted and weighted MRI procedures performed, by CPT code; (5) identify the operating hours of the proposed scanner; (6) provide a description of the capabilities of the proposed scanner; (7) provide documentation of the capacity of the proposed scanner based on the number of days to be operated each week, the number of days to be operated each year, the number of hours to be operated each day, and the average PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2024 number of unweighted MRI procedures the scanner is capable of performing each hour; (8) identify the types of MRI procedures by CPT code that are appropriate to be performed on an extremity MRI scanner as opposed to a whole body MRI scanner; (9) provide copies of the operational and safety requirements set by the manufacturer; and (10) describe the specific criteria and methodology to be implemented for utilization review to ensure the medical necessity of the procedures performed. Authority G.S. 131E-177(1); 131E-183(b). 10A NCAC 14C .2703 PERFORMANCE STANDARDS (a) An applicant proposing to acquire a mobile magnetic resonance imaging (MRI) scanner shall: (1) demonstrate that each existing mobile MRI scanner which the applicant or a related entity owns a controlling interest in and operates in the mobile MRI region in which the proposed equipment will be located, except temporary MRI scanners, performed 3,328 weighted MRI procedures in the most recent 12 month period for which the applicant has data. data [Note: This is not the average number of weighted MRI procedures performed on all of the applicant's mobile MRI scanners.]; with the exception that in the event an existing mobile MRI scanner has been in operation less than 12 months at the time the application is filed, the applicant shall demonstrate that this mobile MRI scanner performed an average of at least 277 weighted MRI procedures per month for the period in which it has been in operation; (2) demonstrate annual utilization in the third year of operation is reasonably projected to be at least 3328 weighted MRI procedures on each of the existing, approved and proposed mobile MRI scanners owned by the applicant or a related entity to be operated in the mobile MRI region in which the proposed equipment will be located. [Note: This is not the average number of weighted MRI procedures performed on all of the applicant's mobile MRI scanners.]; (3) document the assumptions and provide data supporting the methodology used for each projection required in this Rule. (b) An applicant proposing to acquire a fixed magnetic resonance imaging (MRI) scanner, except for fixed MRI scanners described in Paragraphs (c) and (d) of this Rule, shall: (1) demonstrate that the existing fixed MRI scanners which the applicant or a related entity owns a controlling interest in and locates in the proposed MRI service area performed an average of 3,328 weighted MRI procedures in the most recent 12 month period for which the applicant has data; (2) demonstrate that each existing mobile MRI scanner which the applicant or a related entity owns a controlling interest in and operates in the proposed mobile MRI region, MRI service area except temporary MRI scanners, performed 3,328 weighted MRI procedures in the most recent 12 month period for which the applicant has data. [Note: This is not the average number of weighted MRI procedures performed on all of the applicant's mobile MRI scanners.]; (3) demonstrate that the average annual utilization of the existing, approved and proposed fixed MRI scanners which the applicant or a related entity owns a controlling interest in and locates in the proposed MRI service area are reasonably expected to perform the following number of weighted MRI procedures, whichever is applicable, in the third year of operation following completion of the proposed project: (A) 1,716 weighted MRI procedures in MRI service areas in which the SMFP shows no fixed MRI scanners are located, (B) 3,775 weighted MRI procedures in MRI service areas in which the SMFP shows one fixed MRI scanner is located, (C) 4,118 weighted MRI procedures in MRI service areas in which the SMFP shows two fixed MRI scanners are located, (D) 4,462 weighted MRI procedures in MRI service areas in which the SMFP shows three fixed MRI scanners are located, or (E) 4,805 weighted MRI procedures in MI MRI service areas in which the SMFP shows four or more fixed MRI scanners are located; (4) if the proposed MRI scanner will be located at a different site from any of the existing or approved MRI scanners owned by the applicant or a related entity, demonstrate that the annual utilization of the proposed fixed MRI scanner is reasonably expected to perform the following number of weighted MRI procedures, whichever is applicable, in the third year of operation following completion of the proposed project: (A) 1,716 weighted MRI procedures in MRI service areas in which the SMFP shows no fixed MRI scanners are located, (B) 3,775 weighted MRI procedures in MRI service areas in which the SMFP shows one fixed MRI scanner is located, PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2025 (C) 4,118 weighted MRI procedures in MRI service areas in which the SMFP shows two fixed MRI scanners are located, (D) 4,462 weighted MRI procedures in MRI service areas in which the SMFP shows three fixed MRI scanners are located, or (E) 4,805 weighted MRI procedures in MRI service areas in which the SMFP shows four or more fixed MRI scanners are located; (4)(5) demonstrate that annual utilization of each existing, approved and proposed mobile MRI scanner which the applicant or a related entity owns a controlling interest in and locates in the proposed MRI service area is reasonably expected to perform 3,328 weighted MRI procedures in the third year of operation following completion of the proposed project. [Note: This is not the average number of weighted MRI procedures to be performed on all of the applicant's mobile MRI scanners.]; (5)(6) document the assumptions and provide data supporting the methodology used for each projection required in this Rule. (c) An applicant proposing to acquire a fixed dedicated breast magnetic resonance imaging (MRI) scanner for which the need determination in the State Medical Facilities Plan was based on an approved petition for an adjustment to the need determination shall: (1) demonstrate annual utilization of the proposed MRI scanner in the third year of operation is reasonably projected to be at least 1,716 1,664 weighted MRI procedures per year; which is .80 X 1 procedure per hour X 40 hours per week X 52 weeks per year; and (2) document the assumptions and provide data supporting the methodology used for each projection required in this Rule. (d) An applicant proposing to acquire a dedicated fixed pediatric a fixed extremity MRI scanner for which the need determination in the State Medical Facilities Plan was based on an approved petition for an adjustment to the need determination shall: (1) demonstrate annual utilization of the proposed MRI scanner in the third year of operation is reasonably projected to be at least 2746 weighted MRI procedures (i.e., 80 percent of one procedure per hour, 66 hours per week, 52 weeks per year); 80 percent of the capacity defined by the applicant in response to 10A NCAC 14C .2702(f)(6), and (2) document the assumptions and provide data supporting the methodology used for each projection required in this Rule. Authority G.S. 131E-177(1); 131E-183(b). 10A NCAC 14C .2704 SUPPORT SERVICES (a) An applicant proposing to acquire a mobile MRI scanner shall provide referral agreements between each host site and at least one other provider of MRI services in the proposed MRI service area geographic area to be served by the host site, to document the availability of MRI services if patients require them when the mobile unit is not in service at that host site. (b) An applicant proposing to acquire a dedicated fixed pediatric MRI scanner shall provide a written policy regarding pediatric sedation which outlines the criteria for sedating a pediatric patient, including the special needs patients, and identifies the staff that will administer and supervise the sedation process. (c) An applicant proposing to acquire a dedicated fixed pediatric MRI scanner shall provide evidence of the availability of a pediatric code cart at the facility where the proposed pediatric MRI scanner will be located and a plan for emergency situations as described in 10A NCAC 14C .2702(f)(2). (d)(b) An applicant proposing to acquire a fixed or mobile MRI scanner shall obtain accreditation from the Joint Commission for the Accreditation of Healthcare Organizations, the American College of Radiology or a comparable accreditation authority, as determined by the Certificate of Need Section, for magnetic resonance imaging within two years following operation of the proposed MRI scanner. Authority G.S. 131E-177(1); 131E-183(b). 10A NCAC 14C .2705 STAFFING AND STAFF TRAINING (a) An applicant proposing to acquire an MRI scanner, including extremity and breast MRI scanners, shall demonstrate that one diagnostic radiologist certified by the American Board of Radiologists shall be available to provide the proposed services interpret the images who has had: (1) training in magnetic resonance imaging as an integral part of his or her residency training program; or (2) six months of supervised MRI experience under the direction of a certified diagnostic radiologist; or (3) at least six months of fellowship training, or its equivalent, in MRI; or (4) a combination of MRI experience and fellowship training equivalent to Subparagraph (a)(1), (2) or (3) of this Rule. (b) An applicant proposing to acquire a dedicated fixed breast MRI scanner shall provide documentation that that: the radiologist is trained and has experience in interpreting images produced by an MRI scanner configured exclusively to perform mammographic studies. (1) the radiologist is trained and has specific expertise in breast imaging, including mammography, breast ultrasound and breast MRI procedures; and (2) two full time MRI technologists or two mammography technologists are available with specialized training in breast MRI imaging and that one of these technologists shall be present during the hours operation of the dedicated breast MRI scanner. PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2026 (c) An applicant proposing to acquire a MRI scanner, including extremity but excluding dedicated breast MRI scanners, shall provide evidence of the availability of two full-time MRI technologist-radiographers and that one of these technologists shall be present during the hours of operation of the MRI scanner. (d) An applicant proposing to acquire an MRI scanner, including extremity and breast MRI scanners, shall demonstrate that the following staff training is provided: (1) American Red Cross or American Heart Association certification in cardiopulmonary resuscitation (CPR) and basic cardiac life support; and (2) the availability of an organized program of staff education and training which is integral to the services program and ensures improvement in technique and the proper training of new personnel. (e) An applicant proposing to acquire a mobile MRI scanner shall document that the requirements in Paragraphs Paragraph (a) and (c) of this Rule shall be met at each host facility. facility, and that one full time MRI technologist-radiographer shall be present at each host facility during all hours of operation of the proposed mobile MRI scanner. (f) An applicant proposing to acquire a dedicated fixed pediatric an extremity MRI scanner scanner, pursuant to a need determination in the State Medical Facilities Plan for a demonstration project, also shall provide: (1) provide documentation of the availability of at least two radiologists, certified by the American Board of Radiology, with a pediatric fellowship or two years of specialized training in pediatrics; (2)(1) provide evidence that the applicant will have at least one licensed physician shall be on-site during the hours of operation of the proposed MRI scanner; (3) provide documentation that the applicant will employ at least two licensed registered nurses and that one of these nurses shall be present during the hours of operation of the proposed MRI scanner; (4)(2) provide a description of a research group for the project including a radiologist, neurologist, pediatric sedation specialist orthopaedic surgeon, and research coordinator; and (5) provide documentation of the availability of the research group to conduct research studies on the proposed MRI scanner; and (6)(3) provide letters from the proposed members of the research group indicating their qualifications, experience and willingness to participate on the research team. (g) An applicant proposing to perform cardiac MRI procedures shall provide documentation of the availability of a radiologist, certified by the American Board of Radiology, with training and experience in interpreting images produced by an MRI scanner configured to perform cardiac MRI studies. Authority G.S. 131E-177(1); 131E-183(b). SECTION .2800 - CRITERIA AND STANDARDS FOR REHABILITATION SERVICES 10A NCAC 14C .2801 DEFINITIONS The definitions in this Rule will apply to all rules in this Section. (1) "Rehabilitation Facility" means a facility as defined in G.S. 131E-176. (2) "Rehabilitation" means the process to maintain, restore or increase the function of disabled individuals so that an individual can live in the least restrictive environment, consistent with his or her objective. (3) "Outpatient Rehabilitation Clinic" is defined as a program of coordinated and integrated outpatient services, evaluation, or treatment with emphasis on improving the functional level of the person in coordination with the patient's family. (4) "Rehabilitation Beds" means inpatient beds for which a need determination is set forth in 10 NCAC 14B the current State Medical Facilities Plan and which are located in a hospital licensed pursuant to G.S. 131E-77 or a nursing facility licensed pursuant to G.S. 131E-102. G.S. 131E-77. (5) "Traumatic Brain Injury" is defined as an insult to the brain that may produce a diminished or altered state of consciousness which results in impairment of cognitive abilities or physical functioning. It can also result in the disturbance of behavioral or emotional functioning. These impairments may be either temporary or permanent and cause partial or total functional disability or psychological maladjustment. (6) "Stroke" (cerebral infarction, hemorrhage) is defined as the sudden onset of a focal neurologic deficit due to a local disturbance in the blood supply to the brain. (7) "Spinal Cord Injury" is defined as an injury to the spinal cord that results in the loss of motor or sensory function. (8) "Pediatric Rehabilitation" is defined as inpatient rehabilitation services provided to persons 14 years of age or younger. Authority G.S. 131E-177; 131E-183(b). 10A NCAC 14C .2806 QUALITY OF SERVICES A proposal to add rehabilitation beds to an existing facility shall document that the facility has not operated on a provisional license beyond the effective date of the initial provisional license issued for a new operator, received an administrative penalty or had its admissions suspended within the 18 month period immediately preceding the submittal of the certificate of need application. Authority G.S. 131E-177; 131E-183(b). PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2027 SECTION .3500 - CRITERIA AND STANDARDS FOR ONCOLOGY TREATMENT CENTERS 10A NCAC 14C .3501 DEFINITIONS The following definitions shall apply to all rules in this section: (1) "Major medical equipment" is defined in G.S. 131E-176(14f). (2) "Medical equipment" means equipment used by the oncology treatment center to diagnose or treat disease or injury in patients, including major medical equipment. (3) "Medical oncologist" is a physician with a special interest in and competence in managing patients with cancer. (4) "Medicine-Oncology" means a clinical medical specialty with a specific involvement with the treatment of tumors. (5) "Oncology diagnostic services" means those services which include, but are not limited to, procedures using diagnostic radiology and imaging techniques, clinical and pathological laboratory tests, or physical examination to obtain information from which a diagnosis is established. (6) "Oncology evaluation services" means the compilation of all diagnostic test results and consultation reports for the development of a patient specific treatment plan to provide curative or palliative cancer treatment. (7) "Oncology treatment center" is defined in G.S. 131E-176(18a). (8) "Oncology treatment center service area" means the geographic area defined by the applicant from which patients will originate who will receive the health services proposed. (9) "Oncology treatment services" means curative or palliative services provided to cancer patients which involve the use of radiation therapy, chemotherapy or other treatment techniques. (10) "Radiation oncologist" means a medical physician with a special interest, training and competence in managing patients with cancer who is certified by the American Board of Radiology or its equivalent. (11) "Radiology-Oncology" means a clinical medical specialty involving the treatment of tumors, particularly as they relate to treatment with ionizing radiation. Authority G.S. 131E-177(1); 131E-183(b). 10A NCAC 14C .3502 INFORMATION REQUIRED OF APPLICANT (a) An applicant proposing to develop a new oncology treatment center shall use the Acute Care Facility/Medical Equipment application form. (b) An applicant shall also submit the following additional information: (1) documentation of the number of existing oncology treatment centers and other health service facilities which provide similar services in the proposed oncology treatment center's service area; (2) a list of the medical/surgical specialties in the existing oncology treatment centers and other health service facilities which provide similar services in the proposed oncology treatment center service area, such as Radiation- Oncology, Medicine-Oncology, and surgical specialties; (3) a list of the medical equipment that is proposed to be acquired; (4) documentation verifying the actual cost or market value of each item of medical equipment, whichever is greater; (5) documentation that the proposed services shall result in an integrated multidisciplinary effort to diagnose and treat patients' clinical and psychosocial needs; (6) a list of all oncology diagnostic, oncology evaluation, and oncology treatment services that shall be available, and documentation demonstrating the means by which these services shall be provided; (7) documentation that coordination and referral agreements exist with a hospital, referring physicians, and surgical and medical specialists and subspecialists; and (8) documentation that the services shall be offered in a physical environment that conforms to the requirements of federal, state, and local regulatory bodies. (c) An applicant proposing to acquire radiation therapy equipment shall document compliance with 10A NCAC 14C .1900, Criteria and Standards for Radiation Therapy Equipment. (d) An applicant proposing to develop a new oncology treatment center shall provide: (1) the number of patients that are projected to use the service, by diagnosis; (2) the number of patients that are projected to use the service, by county of residence; (3) documentation of the maximum number of procedures that the equipment in the facility is capable of performing and the assumptions used to determine the maximum number of procedures; (4) quarterly projected utilization of the applicant's new equipment for each of the first three years after the completion of the project; (5) documentation of the effect the new oncology treatment center may have on existing oncology treatment centers and other health service facilities which provide similar services in the proposed oncology treatment center service area; and (6) all the assumptions and data supporting the methodology used to make the above projections. PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2028 Authority G.S. 131E-177(1); 131E-183. 10A NCAC 14C .3504 SUPPORT SERVICES (a) An applicant proposing to develop an oncology treatment center shall document that the following services will be available to the center: (1) medical oncology services; (2) radiation oncology services; (3) diagnostic radiology services; (4) nuclear medicine services; (5) hospice and home health services; (6) psychology and social services; (7) pharmaceutical services; (8) pathology services; (9) transportation services; and (10) tumor registry services. (b) An applicant proposing to develop an oncology treatment center shall specify whether any services other than those listed in Paragraph (a) of this Rule will be available to the center and shall list those additional services. (c) An applicant proposing to develop an oncology treatment center shall list the types of surgical specialties which will be available to the center. (d) An applicant proposing to develop an oncology treatment center for the provision of medical-oncology services shall document that the following services will be available in the center: (1) pharmaceutical services; and (2) pathology services. (e) An applicant proposing to develop an oncology treatment center for the provision of radiation-oncology services shall document that diagnostic radiology services will be available in the center. Authority G.S. 131E-177(1); 131E-183(b). 10A NCAC 14C .3505 STAFFING AND STAFF TRAINING An applicant proposing to establish a new oncology treatment center shall provide the following information: (1) the medical specialties and board certification status of each physician who will provide services in the proposed center. An applicant shall also provide documentation of at least the following types of physicians: (a) if proposing radiation-therapy services, a radiation oncologist; (b) if proposing radiation-therapy services, access to a medical oncologist; (2) a description of the special training and specialty certification which will be required of all registered nurses who will be employed by the center; (3) documentation to show the types and numbers of staff, particularly qualified medical technologists and medical staff, that shall be available to support the services and an explanation as to why these staff are adequate to provide the proposed services; and (4) documentation to demonstrate that a formal training program exists to ensure the continued proficiency of the professional and technical staff. Authority G.S. 131E-177(1); 131E-183(b). SECTION .3700 - CRITERIA AND STANDARDS FOR POSITRON EMISSION TOMOGRAPHY SCANNER 10A NCAC 14C .3702 INFORMATION REQUIRED OF APPLICANT (a) An applicant proposing to acquire a PET scanner, including a mobile PET scanner, shall use the Acute Care Facility/Medical Equipment application form. (b) An applicant proposing to acquire a PET scanner, including a mobile PET scanner, shall provide the following information for each facility where the PET scanner will be operated: (1) The projected number of procedures to be performed and the projected number of patients to be served for each of the first three years following completion of the proposed project. Projections shall be listed by clinical area (e.g., oncology, cardiology), and all methodologies and assumptions used in making the projections shall be provided. (2) Documentation that all of the following services were provided, at each facility where the PET scanner will be operated, continuously throughout the 12 months immediately prior to the date on which the application is filed: (A) nuclear medicine imaging services; (B) single photon emission computed tomography (including brain, bone, liver, gallium and thallium stress); (C) magnetic resonance imaging scans; (D) computerized tomography scans; (E) cardiac angiography; (F) cardiac ultrasound; and (G) neuroangiography. (3) Documentation that the facility will: (A) establish the clinical PET unit, and any accompanying equipment used in the manufacture of positron-emitting radioisotopes, as a regional resource that will have no administrative, clinical or charge requirements that would impede physician referrals of patients for whom PET testing would be appropriate; and (B) provide scheduled hours of operation for the PET scanner of a minimum of 12 hours per day, six days a week, except for mobile scanners; and scanners. (C) implement a referral system which shall include a feedback mechanism PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2029 of providing patient information to the referring physician and facility. (4) A description of the protocols that will be established to assure that all clinical PET procedures performed are medically necessary and cannot be performed using other, less expensive, established modalities. (c) An applicant proposing to acquire a mobile PET scanner shall provide copies of letters of intent from and proposed contracts with all of the proposed host facilities at which the mobile PET scanner will be operated. (d) An applicant proposing to acquire a mobile PET scanner shall demonstrate that each host facility offers or contracts with a hospital that offers comprehensive cancer services including radiation oncology, medical oncology, and surgical oncology. (e) An applicant shall document that all equipment, supplies and pharmaceuticals proposed for the service have been certified for use by the U.S. Food and Drug Administration or will be used under an institutional review board whose membership is consistent with U.S. Department of Health and Human Services' regulations. (f) An applicant shall document that each PET scanner and cyclotron shall be operated in a physical environment that conforms to federal standards, manufacturers manufacturer's specifications, and licensing requirements. The following shall be addressed: (1) quality control measures and assurance of radioisotope production of generator or cyclotron-produced agents; (2) quality control measures and assurance of PET tomograph tomography and associated instrumentation; (3) radiation protection and shielding; (4) radioactive emission to the environment; and (5) radioactive waste disposal. Authority G.S. 131E-177(1); 131E-183(b). 10A NCAC 14C .3703 PERFORMANCE STANDARDS (a) An applicant proposing to acquire a dedicated PET scanner, including a mobile dedicated PET scanner, shall demonstrate that: (1) the proposed dedicated PET scanner, including a proposed mobile dedicated PET scanner, shall be utilized at an annual rate of at least 3,200 2,080 PET procedures by the end of the third year following completion of the project; (2) if an applicant operates an existing dedicated PET scanner, its existing dedicated PET scanners, excluding those used exclusively for research, performed an average of at least 3,200 2,080 PET procedures per PET scanner in the last year; and (3) its existing and approved dedicated PET scanners shall perform an average of at least 3,200 2,080 PET procedures per PET scanner during the third year following completion of the project. (b) The applicant shall describe the assumptions and provide data to support and document the assumptions and methodology used for each projection required in this Rule. Authority G.S. 131E-177(1); 131E-183(b). 10A NCAC 14C .3704 SUPPORT SERVICES (a) An applicant proposing to acquire a PET scanner, including a mobile PET scanner, shall document how medical emergencies within the PET scanner unit will be managed at each facility where the PET scanner will be operated. (b)(a) An applicant proposing to acquire a PET scanner, including a mobile PET scanner, shall document that radioisotopes shall be acquired from one or more of the following sources and shall identify the sources which will be utilized by the applicant: (1) an off-site medical cyclotron and radioisotope production facility that is located within two hours transport time to each facility where the PET scanner will be operated; (2) an on-site rubidium-82 generator; or (3) an on-site medical cyclotron for radio nuclide production and a chemistry unit for labeling radioisotopes. (c)(b) An applicant proposing to acquire an on-site cyclotron for radioisotope production shall document that these agents are not available or cannot be obtained in an economically cost effective manner from an off-site cyclotron located within 2 hours total transport time from the applicant's facility. (d)(c) An applicant proposing to develop new PET scanner services, including mobile PET scanner services, shall establish a clinical oversight committee at each facility where the PET scanner will be operated before the proposed PET scanner is placed in service that shall: (1) develop screening criteria for appropriate PET scanner utilization; (2) review clinical protocols; (3) review appropriateness and quality of clinical procedures; (4) develop educational programs; and (5) oversee the data collection and evaluation activities of the PET scanning service. Authority G.S. 131E-177(1); 131E-183(b). SECTION .3900 - CRITERIA AND STANDARDS FOR GASTROINTESTINAL ENDOSCOPY PROCEDURE ROOMS IN LICENSED HEALTH SERVICE FACILTIES 10A NCAC 14C .3901 DEFINITIONS The following definitions shall apply to all rules in this Section: (1) "Ambulatory surgical facility" means a facility as defined in G.S. 131E-176(1b). (2) "Gastrointestinal (GI) endoscopy room" means a room as defined in G.S. 131E-176(7d) that is used to perform one or more GI endoscopy procedures. (3) "Gastrointestinal (GI) endoscopy procedure" means a single procedure, identified by CPT code or ICD-9-CM procedure code, performed PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2030 on a patient during a single visit to the facility for diagnostic or therapeutic purposes. (4) "Operating room" means a room as defined in G.S. 131E-176(18c). (5) "Related entity" means the parent company of the applicant, a subsidiary company of the applicant (i.e., the applicant owns 50 percent or more of another company), a joint venture in which the applicant is a member, or a company that shares common ownership with the applicant (i.e., the applicant and another company are owned by some of the same persons). (6) "Service area" means the geographical area, as defined by the applicant using county lines, from which the applicant projects to serve patients. Authority G.S. 131E-177(1); 131E-183(b). 10A NCAC 14C .3902 INFORMATION REQUIRED OF APPLICANT (a) An applicant proposing to establish a new licensed ambulatory surgical facility for performance of GI endoscopy procedures or develop a GI endoscopy room in an existing licensed health service facility shall provide the following information: (1) the counties included in the applicant's proposed service area, as defined in 10A NCAC 14C .3906; (2) with regard to services provided in the applicant's GI endoscopy rooms, identify: (A) the number of existing and proposed GI endoscopy rooms in the licensed health service facility in which the proposed rooms will be located; (B) the number of existing or approved GI endoscopy rooms in any other licensed health service facility in which the applicant or a related entity has a controlling interest that is located in the applicant's proposed service area; (C) the number of GI endoscopy procedures, identified by CPT code or ICD-9-CM procedure code, performed in the applicant's licensed or non-licensed GI endoscopy rooms in the last 12 months; (D) the number of GI endoscopy procedures, identified by CPT code or ICD-9-CM procedure code, projected to be performed in the GI endoscopy rooms in each of the first three operating years of the project (E) the number of procedures by type, other than GI endoscopy procedures, performed in the GI endoscopy rooms in the last 12 months; (F) the number of procedures by type, other than GI endoscopy procedures, projected to be performed in the GI endoscopy rooms in each of the first three operating years of the project; (G) the number of patients served in the licensed or non-licensed GI endoscopy rooms in the last 12 months; and, (H) the number of patients projected to be served in the GI endoscopy rooms in each of the first three operating years of the project; (3) with regard to services provided in the applicant's operating rooms identify: (A) the number of existing operating rooms in the facility; (B) the number of procedures by type performed in the operating rooms in the last 12 months; and (C) the number of procedures by type projected to be performed in the operating rooms in each of the first three operating years of the project; (4) the days and hours of operation of the facility in which the GI endoscopy rooms will be located; (5) if an applicant is an existing facility, the type and average facility charge for each of the ten GI endoscopy procedures most commonly performed in the facility during the preceding 12 months; (6) the type and projected average facility charge for the 10 GI endoscopy procedures which the applicant projects will be performed most often in the facility; (7) a list of all services and items included in each charge, and a description of the bases on which these costs are included in the charge; (8) identification of all services and items (e.g., medications, anesthesia) that will not be included in the facility's charges; (9) if an applicant is an existing facility, the average reimbursement received per procedure for each of the ten GI endoscopy procedures most commonly performed in the facility during the preceding 12 months; and (10) the average reimbursement projected to be received for each of the ten GI endoscopy procedures which the applicant projects will be performed most frequently in the facility. (b) An applicant proposing to establish a new licensed ambulatory surgical facility for provision of GI endoscopy procedures shall submit the following information: (1) a copy of written administrative policies that prohibit the exclusion of services to any patient on the basis of age, race, religion, disability or the patient's ability to pay; (2) a written commitment to participate in and comply with conditions of participation in the PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2031 Medicare and Medicaid programs within three months after licensure of the facility; (3) a description of strategies to be used and activities to be undertaken by the applicant to assure the proposed services will be accessible by indigent patients without regard to their ability to pay; (4) a written description of patient selection criteria including referral arrangements for high-risk patients; (5) the number of GI endoscopy procedures performed by the applicant in any other existing licensed health service facility in each of the last 12 months, by facility; (6) if the applicant proposes reducing the number of GI endoscopy procedures it performs in existing licensed facilities, the specific rationale for its change in practice pattern. Authority G.S. 131E-177; 131E-183(b). 10A NCAC 14C .3903 PERFORMANCE STANDARDS (a) In providing projections for operating rooms, as required in this rule, the operating rooms shall be considered to be available for use 250 days per year, which is five days per week, 52 weeks per year, excluding ten days for holidays. (b) An applicant proposing to establish a new licensed ambulatory surgical facility for performance of GI endoscopy procedures or develop a GI endoscopy room in an existing licensed health service facility shall reasonably project to perform an average of at least 1,500 GI endoscopy procedures only per GI endoscopy room in each licensed facility the applicant or a related entity owns in the proposed service area, during the second year of operation following completion of the
Object Description
Description
Title | North Carolina register |
Date | 2006-06-01 |
Description | Volume 20, Issue 23, (June 1, 2006) |
Digital Characteristics-A | 1 MB; 150 p. |
Digital Format |
application/pdf |
Pres Local File Path-M | \Preservation_content\StatePubs\pubs_borndigital\images_master\ |
Full Text | NORTH CAROLINA REGISTER Volume 20, Issue 23 Pages 2007 - 2152 June 1, 2006 This issue contains documents officially filed through May 10, 2006. Office of Administrative Hearings Rules Division 424 North Blount Street (27601) 6714 Mail Service Center Raleigh, NC 27699-6714 (919) 733-2678 FAX (919) 733-3462 Julian Mann III, Director Camille Winston, Deputy Director Molly Masich, Director of APA Services Dana Sholes, Publications Coordinator Julie Brincefield, Editorial Assistant Felicia Williams, Editorial Assistant Lisa Johnson, RRC Administrative Assistant IN THIS ISSUE I. IN ADDITION Secretary of State – Notice.............................................. 2007 Brownfields Property – Imperial Partners....................... 2008 Brownfields Property – Town of Forest City.................. 2009 II. PROPOSED RULES Health and Human Services Facility Services .......................................................... 2010 - 2034 Medical Care Commission .......................................... 2034 – 2035 Labor Mine and Quarry Bureau............................................. 2036 - 2037 III. APPROVED RULES.................................................... 2038 – 2102 Community Colleges Community Colleges, Board of Environment and Natural Resources Radiation Protection Commission Water Treatment Facility Operators Certification Board Wildlife Resources Commission Health and Human Services Child Care Commission Medical Assistance Medical Care Commission Social Services Commission Labor Elevator & Amusement Device Bureau Licensing Boards and Commissions Auctioneer Licensing Board General Contractors, Board of Medical Board Nursing Board Plumbing, Heating & Fire Sprinkler Contractors Veterinary Medical Board Revenue The Department IV. RULES REVIEW COMMISSION.............................. 2103 - 2123 V. CONTESTED CASE DECISIONS Index to ALJ Decisions................................................... 2124 - 2133 Text of Selected Decisions 05 DHR 1077 .............................................................. 2134 - 2141 05 DHR 1392 .............................................................. 2142 - 2152 For the CUMULATIVE INDEX to the NC Register go to: http://reports.oah.state.nc.us/cumulativeIndex.pl North Carolina Register is published semi-monthly for $195 per year by the Office of Administrative Hearings, 424 North Blount Street, Raleigh, NC 27601. North Carolina Register (ISSN 15200604) to mail at Periodicals Rates is paid at Raleigh, NC. POSTMASTER: Send Address changes to the North Carolina Register, 6714 Mail Service Center, Raleigh, NC 27699-6714. NORTH CAROLINA ADMINISTRATIVE CODE CLASSIFICATION SYSTEM The North Carolina Administrative Code (NCAC) has four major classifications of rules. Three of these, titles, chapters, and sections are mandatory. The major classification of the NCAC is the title. Each major department in the North Carolina executive branch of government has been assigned a title number. Titles are further broken down into chapters which shall be numerical in order. Subchapters are optional classifications to be used by agencies when appropriate. NCAC TITLES TITLE 21 LICENSING BOARDS TITLE 24 INDEPENDENT AGENCIES 1 ADMINISTRATION 2 AGRICULTURE & CONSUMER SERVICES 3 AUDITOR 4 COMMERCE 5 CORRECTION 6 COUNCIL OF STATE 7 CULTURAL RESOURCES 8 ELECTIONS 9 GOVERNOR 10A HEALTH AND HUMAN SERVICES 11 INSURANCE 12 JUSTICE 13 LABOR 14A CRIME CONTROL & PUBLIC SAFETY 15A ENVIRONMENT &NATURAL RESOURCES 16 PUBLIC EDUCATION 17 REVENUE 18 SECRETARY OF STATE 19A TRANSPORTATION 20 TREASURER 21* OCCUPATIONAL LICENSING BOARDS 22 ADMINISTRATIVE PROCEDURES (REPEALED) 23 COMMUNITY COLLEGES 24* INDEPENDENT AGENCIES 25 STATE PERSONNEL 26 ADMINISTRATIVE HEARINGS 27 NC STATE BAR 28 JUVENILE JUSTICE AND DELINQUENCY PREVENTION 1 Acupuncture 2 Architecture 3 Athletic Trainer Examiners 4 Auctioneers 6 Barber Examiners 8 Certified Public Accountant Examiners 10 Chiropractic Examiners 11 Employee Assistance Professionals 12 General Contractors 14 Cosmetic Art Examiners 16 Dental Examiners 17 Dietetics/Nutrition 18 Electrical Contractors 19 Electrolysis 20 Foresters 21 Geologists 22 Hearing Aid Dealers and Fitters 25 Interpreter/Transliterator 26 Landscape Architects 28 Landscape Contractors 29 Locksmith Licensing 30 Massage & Bodywork Therapy 31 Marital and Family Therapy 32 Medical Examiners 33 Midwifery Joint Committee 34 Funeral Service 36 Nursing 37 Nursing Home Administrators 38 Occupational Therapists 40 Opticians 42 Optometry 44 Osteopathic Examination (Repealed) 45 Pastoral Counselors, Fee-Based Practicing 46 Pharmacy 48 Physical Therapy Examiners 50 Plumbing, Heating & Fire Sprinkler Contractors 52 Podiatry Examiners 53 Professional Counselors 54 Psychology 56 Professional Engineers & Land Surveyors 57 Real Estate Appraisal 58 Real Estate Commission 60 Refrigeration Examiners 61 Respiratory Care 62 Sanitarian Examiners 63 Social Work Certification 64 Speech & Language Pathologists & Audiologists 65 Therapeutic Recreation Certification 66 Veterinary Medical 68 Substance Abuse Professionals 69 Soil Scientists 1 Housing Finance 2 Agricultural Finance Authority 3 Safety & Health Review Board 4 Reserved 5 State Health Plan Purchasing Alliance Board Note: Title 21 contains the chapters of the various occupational licensing boards and Title 24 contains the chapters of independent agencies. NORTH CAROLINA REGISTER Publication Schedule for January 2006 – December 2006 FILING DEADLINES NOTICE OF TEXT PERMANENT RULE TEMPORARY RULES Volume & issue number Issue date Last day for filing Earliest date for public hearing End of required comment period Deadline to submit to RRC for review at next meeting Earliest Eff. Date of Permanent Rule Delayed Eff. Date of Permanent Rule (first legislative day of the next regular session) 270th day from publication in the Register 20:13 01/03/06 12/08/05 01/18/06 03/06/06 03/20/06 05/01/06 05/09/06 09/30/06 20:14 01/17/06 12/21/05 02/01/06 03/20/06 04/20/06 06/01/06 01/07 10/14/06 20:15 02/01/06 01/10/06 02/16/06 04/03/06 04/20/06 06/01/06 01/07 10/29/06 20:16 02/15/06 01/25/06 03/02/06 04/17/06 04/20/06 06/01/06 01/07 11/12/06 20:17 03/01/06 02/08/06 03/16/06 05/01/06 05/22/06 07/01/06 01/07 11/26/06 20:18 03/15/06 02/22/06 03/30/06 05/15/06 05/22/06 07/01/06 01/07 12/10/06 20:19 04/03/06 03/13/06 04/18/06 06/02/06 06/20/06 08/01/06 01/07 12/29/06 20:20 04/17/06 03/24/06 05/02/06 06/16/06 06/20/06 08/01/06 01/07 01/12/07 20:21 05/01/06 04/07/06 05/16/06 06/30/06 07/20/06 09/01/06 01/07 01/26/07 20:22 05/15/06 04/24/06 05/30/06 07/14/06 07/20/06 09/01/06 01/07 02/09/07 20:23 06/01/06 05/10/06 06/16/06 07/31/06 08/21/06 10/01/06 01/07 02/26/07 20:24 06/15/06 05/24/06 06/30/06 08/14/06 08/21/06 10/01/06 01/07 03/12/07 21:01 07/03/06 06/12/06 07/18/06 09/01/06 09/20/06 11/01/06 01/07 03/30/07 21:02 07/17/06 06/23/06 08/01/06 09/15/06 09/20/06 11/01/06 01/07 04/13/07 21:03 08/01/06 07/11/06 08/16/06 10/02/06 10/20/06 12/01/06 01/07 04/28/07 21:04 08/15/06 07/25/06 08/30/06 10/16/06 10/20/06 12/01/06 01/07 05/12/07 21:05 09/01/06 08/11/06 09/16/06 10/31/06 11/20/06 01/01/07 01/07 05/29/07 21:06 09/15/06 08/24/06 09/30/06 11/14/06 11/20/06 01/01/07 01/07 06/12/07 21:07 10/02/06 09/11/06 10/17/06 12/01/06 12/20/06 02/01/07 05/08 06/29/07 21:08 10/16/06 09/25/06 10/31/06 12/15/06 12/20/06 02/01/07 05/08 07/13/07 21:09 11/01/06 10/11/06 11/16/06 01/01/07 01/22/07 03/01/07 05/08 07/29/07 21:10 11/15/06 10/24/06 11/30/06 01/15/07 01/22/07 03/01/07 05/08 08/12/07 21:11 12/01/06 11/07/06 12/16/06 01/30/07 02/20/07 04/01/07 05/08 08/28/07 21:12 12/15/06 11/22/06 12/30/06 02/13/07 02/20/07 04/01/07 05/08 09/11/07 EXPLANATION OF THE PUBLICATION SCHEDULE This Publication Schedule is prepared by the Office of Administrative Hearings as a public service and the computation of time periods are not to be deemed binding or controlling. Time is computed according to 26 NCAC 2C .0302 and the Rules of Civil Procedure, Rule 6. GENERAL The North Carolina Register shall be published twice a month and contains the following information submitted for publication by a state agency: (1) temporary rules; (2) notices of rule-making proceedings; (3) text of proposed rules; (4) text of permanent rules approved by the Rules Review Commission; (5) notices of receipt of a petition for municipal incorporation, as required by G.S. 120-165; (6) Executive Orders of the Governor; (7) final decision letters from the U.S. Attorney General concerning changes in laws affecting voting in a jurisdiction subject of Section 5 of the Voting Rights Act of 1965, as required by G.S. 120-30.9H; (8) orders of the Tax Review Board issued under G.S. 105-241.2; and (9) other information the Codifier of Rules determines to be helpful to the public. COMPUTING TIME: In computing time in the schedule, the day of publication of the North Carolina Register is not included. The last day of the period so computed is included, unless it is a Saturday, Sunday, or State holiday, in which event the period runs until the preceding day which is not a Saturday, Sunday, or State holiday. FILING DEADLINES ISSUE DATE: The Register is published on the first and fifteen of each month if the first or fifteenth of the month is not a Saturday, Sunday, or State holiday for employees mandated by the State Personnel Commission. If the first or fifteenth of any month is a Saturday, Sunday, or a holiday for State employees, the North Carolina Register issue for that day will be published on the day of that month after the first or fifteenth that is not a Saturday, Sunday, or holiday for State employees. LAST DAY FOR FILING: The last day for filing for any issue is 15 days before the issue date excluding Saturdays, Sundays, and holidays for State employees. NOTICE OF TEXT EARLIEST DATE FOR PUBLIC HEARING: The hearing date shall be at least 15 days after the date a notice of the hearing is published. END OF REQUIRED COMMENT PERIOD An agency shall accept comments on the text of a proposed rule for at least 60 days after the text is published or until the date of any public hearings held on the proposed rule, whichever is longer. DEADLINE TO SUBMIT TO THE RULES REVIEW COMMISSION: The Commission shall review a rule submitted to it on or before the twentieth of a month by the last day of the next month. FIRST LEGISLATIVE DAY OF THE NEXT REGULAR SESSION OF THE GENERAL ASSEMBLY: This date is the first legislative day of the next regular session of the General Assembly following approval of the rule by the Rules Review Commission. See G.S. 150B- 21.3, Effective date of rules. IN ADDITION 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2007 Note from the Codifier: This Section contains public notices that are required to be published in the Register or have been approved by the Codifier of Rules for publication. DEPARTMENT OF THE SECRETARY OF STATE NOTICE OF PUBLIC HEARING Pursuant to G.S. 150B-21.2(e), the Department will conduct a public hearing regarding proposed administrative rules concerning regulation of lobbying filed with the Office of Administrative Hearings on April 24, 2006, cited as 18 NCAC 12 .0101-.0117 and 18 NCAC 13 .0101-.0116. The public hearing will be held as follows: Date: Monday, June 19, 2006 Time: 9:00 a.m. Location: Department of Commerce's Utilities Commission Hearing Room (#2115), Dobbs Building (enter on Mall side of Dobbs Building) Comments may be submitted to: Joal Broun, Secretary of State's Office, 2 South Salisbury Street, Raleigh, NC 27601-2903 or P.O. Box 29622, Raleigh, NC, telephone (919) 807-2005, fax (919) 807-2010, e-mail jbroun@sosnc.com Comment period ends: July 14, 2006 IN ADDITION 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2008 SUMMARY OF NOTICE OF INTENT TO REDEVELOP A BROWNFIELDS PROPERTY Imperial Centre Partners, LP Pursuant to N.C.G.S. § 130A-310.34, Imperial Centre Partners, LP has filed with the North Carolina Department of Environment and Natural Resources ("DENR") a Notice of Intent to Redevelop a Brownfields Property ("Property") in Rocky Mount, Nash County, North Carolina. The Property consists of the former sites of the Imperial Tobacco Plant at 270 Gay Street and the former Braswell Memorial Library at 344 Falls Road and comprises approximately 3.6 acres. Environmental contamination exists on the Property in the soil and groundwater. Imperial Centre Partners, LP has committed itself to redevelopment of the Property for no use other than as a cultural arts center for the City of Rocky Mount. The Notice of Intent to Redevelop a Brownfields Property includes: (1) a proposed Brownfields Agreement between DENR and Imperial Centre Partners, LP, which in turn includes (a) a map showing the location of the Property, (b) a description of the contaminants involved and their concentrations in the media of the Property, (c) the above-stated description of the intended future use of the Property, and (d) proposed investigation and remediation; and (2) a proposed Notice of Brownfields Property prepared in accordance with G.S. 130A-310.35. The full Notice of Intent to Redevelop a Brownfields Property may be reviewed at the Braswell Library, 727 North Grace Street, Rocky Mount by contacting Phillip Whitford at (252) 442-1951, extension 255 or by email at PWhitford@Braswell- Library.org; or at NC Brownfields Program, 401 Oberlin Rd., Suite 150, Raleigh, NC 27605 by contacting Shirley Liggins at that address, at shirley.liggins@ncmail.net, or at (919) 508-8411, where DENR will provide auxiliary aids and services for persons with disabilities who wish to review the documents. Written public comments may be submitted to DENR within 60 days after the date this Notice is published in a newspaper of general circulation serving the area in which the brownfields property is located, or in the North Carolina Register, whichever is later. Written requests for a public meeting may be submitted to DENR within 30 days after the period for written public comments begins. Thus, if Imperial Centre Partners, LP, as it plans, publishes this Summary in the North Carolina Register after it publishes the Summary in a newspaper of general circulation serving the area in which the brownfields property is located, and if it effects publication of this Summary in the North Carolina Register on the date it expects to do so, the periods for submitting written requests for a public meeting regarding this project and for submitting written public comments will commence on June 2, 2006. All such comments and requests should be addressed as follows: Mr. Bruce Nicholson Brownfields Program Manager Division of Waste Management NC Department of Environment and Natural Resources 401 Oberlin Road, Suite 150 Raleigh, North Carolina 27605 IN ADDITION 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2009 SUMMARY OF NOTICE OF INTENT TO REDEVELOP A BROWNFIELDS PROPERTY Town of Forest City Pursuant to N.C.G.S. § 130A-310.34, the Town of Forest City has filed with the North Carolina Department of Environment and Natural Resources ("DENR") a Notice of Intent to Redevelop a Brownfields Property ("Property") in Forest City, Rutherford County, North Carolina. The Property, known as the former Cone Mill site, consists of 9.2 acres and is located at 186 Mill Street; 108, 110 and 112 East Main Street; 125 Depot Street and 139 Depot Street. Environmental contamination exists on the Property in the soil and groundwater. The Town of Forest City has committed itself to limit redevelopment of the Property to commercial, retail, office, residential, storage, hotel, public gathering and open space uses. The Notice of Intent to Redevelop a Brownfields Property includes: (1) a proposed Brownfields Agreement between DENR and RiverLink, Incorporated, which in turn includes (a) a map showing the location of the Property, (b) a description of the contaminants involved and their concentrations in the media of the Property, (c) the above-stated description of the intended future use of the Property, and (d) proposed investigation and remediation; and (2) a proposed Notice of Brownfields Property prepared in accordance with G.S. 130A-310.35. During the 60-day public comment period, the full Notice of Intent to Redevelop a Brownfields Property may be reviewed at Forest City's utility bill payments desk, 128 North Powell Street, Forest City, NC 28043 by contacting Danielle Withrow at that address or at (828) 248-5200; at Forest City's public library, 240 East Main Street, Forest City, NC 28043 by contacting Mary Sandra Costner at that address or at (828) 248-5224; or at the offices of the N.C. Brownfields Program, 401 Oberlin Rd., Suite 150, Raleigh, NC 27605 by contacting Shirley Liggins at that address (where DENR will provide auxiliary aids and services for persons with disabilities who wish to review the documents), at shirley.liggins@ncmail.net, or at (919) 508-8411. Written public comments may be submitted to DENR within 60 days after the date this Notice is published in a newspaper of general circulation serving the area in which the brownfields property is located, or in the North Carolina Register, whichever is later. Written requests for a public meeting may be submitted to DENR within 30 days after the period for written public comments begins. Thus, if the Town of Forest City, as it plans, publishes this Summary in the North Carolina Register after it publishes the Summary in a newspaper of general circulation serving the area in which the brownfields property is located, and if it effects publication of this Summary in the North Carolina Register on the date it expects to do so, the periods for submitting written requests for a public meeting regarding this project and for submitting written public comments will commence on June 2, 2006. All such comments and requests should be addressed as follows: Mr. Bruce Nicholson Brownfields Program Manager Division of Waste Management NC Department of Environment and Natural Resources 401 Oberlin Road, Suite 150 Raleigh, North Carolina 27605 PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2010 Note from the Codifier: The notices published in this Section of the NC Register include the text of proposed rules. The agency must accept comments on the proposed rule(s) for at least 60 days from the publication date, or until the public hearing, or a later date if specified in the notice by the agency. If the agency adopts a rule that differs substantially from a prior published notice, the agency must publish the text of the proposed different rule and accept comment on the proposed different rule for 60 days. Statutory reference: G.S. 150B-21.2. TITLE 10A – DEPARTMENT OF HEALTH AND HUMAN SERVICES Notice is hereby given in accordance with G.S. 150B-21.2 that the Division of Facility Services intends to adopt the rules cited as 10A NCAC 14C .3901-.3906, .4001-.4005; amend the rules cited as 10A NCAC 14C .0203, .1501-.1505, .1601-.1603, .1605, .1901, .2101, .2103, .2203, .2502-.2503, .2505, .2602, .2701- .2705, .2801, .3702-.3704; and repeal the rules cited as 10A NCAC 14C .2806, .3501-.3502, .3504-.3505. Proposed Effective Date: October 1, 2006 Public Hearing: Date: July 27, 2006 Time: 10:00 a.m. Location: Room 201, Council Building, 701 Barbour Drive, Dorothea Dix Campus, Raleigh, North Carolina, 27603 Reason for Proposed Action: Several subject matters are addressed in the State Medical Facilities Plan (SMFP). Changes to existing Certificate of Need rules are required to ensure consistency with the SMFP that became effective January 1, 2006. Procedure by which a person can object to the agency on a proposed rule: An individual may object to the agency on the proposed rule by submitting written comments on the proposed rule. They may also object by attending the public hearing and personally voice their objections during that time. Comments may be submitted to: Elizabeth K. Brown, NC Division of Facility Services, 2701 Mail Service Center, Raleigh, North Carolina, 27699-2701, phone (919) 855-3751; fax (919) 733-2757; email elizabeth.brown@ncmail.net Comment period ends: July 31, 2006 Procedure for Subjecting a Proposed Rule to Legislative Review: If an objection is not resolved prior to the adoption of the rule, a person may also submit written objections to the Rules Review Commission. If the Rules Review Commission receives written and signed objections in accordance with G.S. 150B-21.3(b2) from 10 or more persons clearly requesting review by the legislature and the Rules Review Commission approves the rule, the rule will become effective as provided in G.S. 150B-21.3(b1). The Commission will receive written objections until 5:00 p.m. on the day following the day the Commission approves the rule. The Commission will receive those objections by mail, delivery service, hand delivery, or facsimile transmission. If you have any further questions concerning the submission of objections to the Commission, please call a Commission staff attorney at 919-733-2721. Fiscal Impact: State Local Substantive (>$3,000,000) None CHAPTER 14 – DIRECTOR, DIVISION OF FACILITY SERVICES SUBCHAPTER 14C – CERTIFICATE OF NEED REGULATIONS SECTION .2000 – CRITERIA AND STANDARDS FOR HOME HEALTH SERVICES 10A NCAC 14C .0203 FILING APPLICATIONS (a) An application shall not be reviewed by the agency until it is filed in accordance with this Rule. (b) An original and a copy of the application shall be file-stamped as received by the agency no later than 5:30 p.m. on the 15th day of the month preceding the scheduled review period. In instances when the 15th of the month falls on a weekend or holiday, the filing deadline is 5:30 p.m. on the next business day. An application shall not be included in a scheduled review if it is not received by the agency by this deadline. Each applicant shall transmit, with the application, a fee to be determined according to the following formula: (1) With each application proposing the addition of a sixth bed to an existing or approved five bed intermediate care facility for the mentally retarded, the proponent shall transmit a fee in the amount of two thousand dollars ($2,000). (2) With each application, other than those referenced in Subparagraph (b)(1) of this Rule, proposing no capital expenditure or a capital expenditure of up to, but not including, one million dollars ($1,000,000), the proponent shall transmit a fee in the amount of three thousand five hundred dollars ($3,500). (3) With each application, other than those referenced in Subparagraph (b)(1) of this Rule, proposing a capital expenditure of one million dollars ($1,000,000) or greater, the proponent shall transmit a fee in the amount of three thousand five hundred dollars ($3,500), plus an additional fee equal to .003 of the amount of the proposed capital expenditure in excess of one million dollars ($1,000,000). The additional fee shall be rounded to the nearest PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2011 whole dollar. In no case shall the total fee exceed seventeen thousand five hundred dollars ($17,500). (c) After an application is filed, the agency shall determine whether it is complete for review. An application shall not be considered complete if: (1) the requisite fee has not been received by the agency; or (2) a signed original and copy of the application have not been submitted to the agency on the appropriate application form. (d) If the agency determines the application is not complete for review, it shall mail notice of such determination to the applicant within five business days after the application is filed and shall specify what is necessary to complete the application. If the agency determines the application is complete, it shall mail notice of such determination to the applicant prior to the beginning of the applicable review period. (e) Information requested by the agency to complete the application must be received by the agency no later than 5:30 p.m. on the last working day before the first day of the scheduled review period. The review of an application shall commence in the next applicable review period that commences after the application has been determined to be complete. Authority G.S. 131E-177; 131E-182. SECTION .1500 - CRITERIA AND STANDARDS FOR HOSPICES 10A NCAC 14C .1501 DEFINITIONS The following definitions shall apply to all rules in this Section: (1) "Bereavement counseling" means counseling provided to a hospice patient's family or significant others to assist them in dealing with issues of grief and loss. (2) "Caregiver" means the person whom the patient designates to provide the patient with emotional support, physical care, or both. (3) "Care plan" means a plan as defined in 10A NCAC 13K .0102 of the Hospice Licensing Rules. (4) "Continuous care" means care as defined in 42 CFR 418.204, the Hospice Medicare Regulations. (5) "Home-like" means furnishings of a hospice inpatient facility or a hospice residential care facility as defined in 10A NCAC 13K .1110 or .1204 of the Hospice Licensing Rules. (6)(5) "Homemaker services" means services provided to assist the patient with personal care, maintenance of a safe and healthy environment and implementation of the patient's care plan. (7)(6) "Hospice" means any coordinated program of home care as defined in G.S. 131E-176(13a). (8)(7) "Hospice inpatient facility" means a facility as defined in G.S. 131E-176(13b). (9) "Hospice residential care facility" means a facility as defined in G.S. 131E-176(13c). (10) "Hospice service area" means for residential care facilities, the county in which the hospice residential care facility will be located and the contiguous counties for which the hospice residential care facility will provide services. (11)(8) "Hospice services" means services as defined in G.S. 131E-201(5b). (12)(9) "Hospice staff" means personnel as defined in 10A NCAC 13K .0102 of the Hospice Licensing Rules. (13)(10) "Interdisciplinary team" means personnel as defined in G.S. 131E-201(6). (14)(11) "Palliative care" means treatment as defined in G.S. 131E-201(8). (15)(12) "Respite care" means care provided as defined in 42 CFR 418.98. Authority G.S. 131E-177(1). 10A NCAC 14C .1502 INFORMATION REQUIRED OF APPLICANT (a) An applicant proposing to develop a hospice shall complete the application form for Hospice Services. An applicant proposing to develop hospice inpatient facility beds or hospice residential care facility beds shall complete the application form for Hospice Inpatient and Hospice Residential Care Services. (b) An applicant proposing to develop a hospice, hospice inpatient facility beds, or hospice residential care facility beds shall provide the following information: (1) the annual unduplicated number of hospice patients projected to be served in each of the first two years following completion of the project and the methodology and assumptions used to make the projections; (2) the projected number of duplicated hospice patients to be served by quarter for the first 24 months following completion of the project and the methodology and assumptions used to make the projections; (3) the projected number of patient care days, by level of care (i.e., routine home care, respite care, and inpatient care), by quarter, to be provided in each of the first two years of operation following completion of the project and the methodology and assumptions used to make the projections shall be clearly stated; (4) the projected number of hours of continuous care to be provided in each of the first two years of operation following completion of the project and the methodology and assumptions used to make these projections; (5) the projected average annual cost per hour of continuous care for each of the first two operating years following completion of the project and the methodology and assumptions used to make the projections; (6) the projected average annual cost per patient care day, by level of care (i.e., routine home care, respite care, and inpatient care), for each of the first two operating years following PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2012 completion of the project and the methodology and assumptions used to project the average annual cost; and (7) documentation of attempts made to establish working relationships with sources of referrals to the hospice services and copies of proposed agreements for the provision of inpatient care. (c) An applicant proposing to develop a hospice shall commit that it shall comply with all certification requirements for participation in the Medicare program within one year after issuance of the certificate of need. (d) An applicant proposing to develop hospice inpatient or hospice residential care facility beds shall also provide the following information: (1) a description of the means by which hospice services shall be provided in the patient's own home; (2) copies of the proposed contractual agreements, with a licensed hospice or a licensed home care agency with a hospice designation on its license, for the provision of hospice services in the patient's own home; (3) a copy of the admission policies, including the criteria that shall be used to select persons for admission and to assure that terminally ill patients are served in their own homes as long as possible; and (4) documentation that a home-like setting shall be provided in the facility. Authority G.S. 131E-177(1); 131E-183. 10A NCAC 14C .1503 PERFORMANCE STANDARDS (a) An applicant proposing to develop hospice inpatient facility beds or hospice residential care facility beds shall demonstrate that: (1) the average occupancy rate of the licensed hospice beds in the facility is projected to be at least 50% for the last six months of the first operating year following completion of the project; (2) the average occupancy rate for the licensed hospice beds in the facility is projected to be at least 65% for the second operating year following completion of the project; and (3) if the application is submitted to address the need for a hospice residential care facility, each existing facility which is located in the hospice service area and which has licensed hospice beds of the type proposed by the applicant attained an occupancy rate of at least 65% for the 12 month period reported on that facility's most recent Licensure Renewal Application Form. (b) An applicant proposing to add beds to an existing hospice inpatient facility or hospice residential care facility shall document that the average occupancy of the licensed hospice inpatient and hospice residential care facility beds in its existing facility was at least 65% for the nine months immediately preceding the submittal of the proposal. (c) An applicant proposing to develop a hospice shall demonstrate that no less than 80% of the total combined number of days of hospice care furnished to Medicaid and Medicare patients will be provided in the patients' residences in accordance with 42 CFR 418.302(f)(2). Authority G.S. 131E-177(1). 10A NCAC 14C .1504 SUPPORT SERVICES (a) An applicant proposing to develop a hospice, hospice inpatient facility beds, or hospice residential care facility beds shall demonstrate that the following core services will be provided directly by the applicant to the patient and the patient's family or significant others: (1) nursing services; (2) social work services; (3) counseling services including dietary, spiritual, and family counseling; (4) bereavement counseling services; (5) volunteer services; (6) physician services; and (7) medical supplies. (b) An applicant shall demonstrate that the nursing services listed in Paragraph (a) of this Rule will be available 24 hours a day, seven days a week. (c) An applicant proposing to develop a hospice, hospice inpatient facility beds, or hospice residential care facility beds shall provide documentation that the following services, when ordered by the attending physician and specified in the care plan, shall either be provided directly by the hospice or provided through a contract arranged by the hospice: (1) hospice inpatient care provided in a licensed hospice inpatient facility bed, licensed acute care bed or licensed nursing facility bed, (2) physical therapy, (3) occupational therapy, (4) speech therapy, (5) home health aide services, (6) medical equipment, (7) respite care, (8) homemaker services, and (9) continuous care. (d) An applicant proposing to develop a hospice inpatient facility or a hospice residential care facility shall provide documentation that pharmaceutical services will be provided directly by the facility or by contract. (e)(d) For each of the services listed in Paragraphs Paragraph (c) and (d) of this Rule which are proposed to be provided by contract, the applicant shall provide a copy of a letter from the proposed provider which expresses their interest in working with the proposed facility. Authority G.S. 131E-177(1); 131E-183. 10A NCAC 14C .1505 STAFFING AND STAFF TRAINING (a) An applicant proposing to develop a hospice, hospice inpatient facility beds, or hospice residential care facility beds shall document that staffing for hospice services will be provided in a manner consistent with G.S. 131E, Article 10. PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2013 (b) The applicant shall demonstrate that: (1) the staffing pattern will be consistent with licensure requirements as specified in 10A NCAC 13K, Hospice Licensing Rules; (2) training for all hospice staff and volunteers will meet the requirements as specified in 10A NCAC 13K .0400, Hospice Licensing Rules; (3) a volunteer program will be established and operated in accordance with 10A NCAC 13K .0400 and .0500 and 42 CFR 418.70; (4) an interdisciplinary team will be established which includes, at a minimum, a physician, a licensed nurse, a social worker, a clergy member, and a trained hospice volunteer, as specified in G.S. 131E-201; (5) a qualified health care professional will coordinate the hospice interdisciplinary team to assure implementation of an integrated care plan and the continuous assessment of the needs of the patient and the patient's family or significant others; (6) a written care plan will be developed by the attending physician, the medical director or physician designee, and the interdisciplinary team before care is provided to a patient and the patient's family or significant others; (7) meetings of the interdisciplinary care team and other appropriate personnel will be held on a frequent and regular basis, at least once every two weeks, for the purpose of care plan review and staff support; and (8) each interdisciplinary team member will be provided orientation, training, and continuing education programs appropriate to their responsibilities and to the maintenance of skills necessary for the physical care of the patient and the psychosocial and spiritual care of the patient and the patient's family or significant others. Authority G.S. 131E-177(1). SECTION .1600 – CRITERIA AND STANDARDS FOR CARDIAC CATHETERIZATION EQUIPMENT AND CARDIAC ANGIOPLASTY EQUIPMENT 10A NCAC 14C .1601 DEFINITIONS The following definitions shall apply to all rules in this Section: (1) "Approved" means the equipment was not in operation prior to the beginning of the review period and had been issued a certificate of need. (2) "Capacity" of an item of cardiac catheterization equipment or cardiac angioplasty equipment means 1500 diagnostic-equivalent procedures per year. One therapeutic cardiac catheterization procedure is valued at 1.75 diagnostic-equivalent procedures. One cardiac catheterization procedure performed on a patient age 14 or under is valued at two diagnostic-equivalent procedures. All other procedures are valued at one diagnostic-equivalent procedure. (3) "Cardiac angioplasty equipment" shall have the same meaning as defined in G.S. 131E-176(2e). (4)(3) "Cardiac catheterization equipment" shall have the same meaning as defined in G.S. 131E-176(2f). (5)(4) "Cardiac catheterization procedure", for the purpose of determining utilization in a certificate of need review, means a single episode of diagnostic or therapeutic catheterization which occurs during one visit to a cardiac catheterization room, whereby a flexible tube is inserted into the patient's body and advanced into the heart chambers to perform a hemodynamic or angiographic examination or therapeutic intervention of the left or right heart chamber, or coronary arteries. A cardiac catheterization procedure does not include a simple right heart catheterization for monitoring purposes as might be done in an electrophysiology laboratory, pulmonary angiography procedure, cardiac pacing through a right electrode catheter, temporary pacemaker insertion, or procedures performed in dedicated angiography or electrophysiology rooms. (6)(5) "Cardiac catheterization room" means a room or a mobile unit in which there is cardiac catheterization or cardiac angioplasty equipment for the performance of cardiac catheterization procedures. Dedicated angiography rooms and electrophysiology rooms are not cardiac catheterization rooms. (7)(6) "Cardiac catheterization service area" means a geographical area defined by the applicant, which has boundaries that are not farther than 90 road miles from the facility, if the facility has a comprehensive cardiac services program; and not farther than 45 road miles from the facility if the facility performs only diagnostic cardiac catheterization procedures; except that the cardiac catheterization service area of an academic medical center teaching hospital designated in 10A NCAC 14B shall not be limited to 90 road miles. (8)(7) "Cardiac catheterization services" means the provision of diagnostic cardiac catheterization procedures or therapeutic cardiac catheterization procedures performed utilizing cardiac catheterization equipment or cardiac angioplasty equipment in a cardiac catheterization room. (9)(8) "Comprehensive cardiac services program" means a cardiac services program which provides the full range of clinical services associated with the treatment of cardiovascular PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2014 disease including community outreach, emergency treatment of cardiovascular illnesses, non-invasive diagnostic imaging modalities, diagnostic and therapeutic cardiac catheterization procedures, open heart surgery and cardiac rehabilitation services. Community outreach and cardiac rehabilitation services shall be provided by the applicant or through arrangements with other agencies and facilities located in the same city. All other components of a comprehensive cardiac services program shall be provided within a single facility. (10)(9) "Diagnostic cardiac catheterization procedure", for the purpose of determining utilization in a certificate of need review, means a cardiac catheterization procedure performed for the purpose of detecting and identifying defects or diseases in the coronary arteries or veins of the heart, or abnormalities in the heart structure, but not the pulmonary artery. (11)(10) "Electrophysiology procedure" means a diagnostic or therapeutic procedure performed to study the electrical conduction activity of the heart and characterization of atrial ventricular arrhythmias. (12)(11) "Existing" means the equipment was in operation prior to the beginning of the review period. (13)(12) "High-risk patient" means a person with reduced life expectancy because of left main or multi-vessel coronary artery disease, often with impaired left ventricular function and with other characteristics as referenced in the American College of Cardiology/American Heart Association Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories (1991) American College of Cardiology/ Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards (June 2001) report. (14)(13) "Mobile equipment" means cardiac angioplasty equipment or cardiac catheterization equipment and transporting equipment which is moved to provide services at two or more host facilities. (15)(14) "Percutaneous transluminal coronary angioplasty (PTCA)" is one type of therapeutic cardiac catheterization procedure used to treat coronary artery disease in which a balloon-tipped catheter is placed in the diseased artery and then inflated to compress the plaque blocking the artery. (16)(15) "Primary cardiac catheterization service area" means a geographical area defined by the applicant, which has boundaries that are not farther than 45 road miles from the facility, if the facility has a comprehensive cardiac services program; and not farther than 23 road miles from the facility if the facility performs only diagnostic cardiac catheterization procedures; except that the primary cardiac catheterization service area of an academic medical center teaching hospital designated in 10A NCAC 14B shall not be limited to 45 road miles. (17)(16) "Therapeutic cardiac catheterization procedure", for the purpose of determining utilization in a certificate of need review, means a cardiac catheterization procedure performed for the purpose of treating or resolving anatomical or physiological conditions which have been determined to exist in the heart or coronary arteries or veins of the heart, but not the pulmonary artery. Authority G.S. 131E-177(1); 131E-183. 10A NCAC 14C .1602 INFORMATION REQUIRED OF APPLICANT (a) An applicant that proposes to acquire cardiac catheterization or cardiac angioplasty equipment shall use the acute care facility/medical equipment application form. (b) The applicant shall provide the following additional information based on the population residing within the applicant's proposed cardiac catheterization service area: (1) the projected annual number of cardiac catheterization procedures, by CPT or ICD-9-CM codes, classified by adult diagnostic, adult therapeutic and pediatric cardiac catheterization procedure, to be performed in the facility during each of the first three years of operation following completion of the proposed project, including the methodology and assumptions used for these projections; (2) documentation of the applicant's experience in treating cardiovascular patients at the facility during the past 12 months, including: (A) the number of patients receiving stress tests; (B) the number of patients receiving intravenous thrombolytic therapies; (C) the number of patients presenting in the Emergency Room or admitted to the hospital with suspected or diagnosed acute myocardial infarction; (D) the number of patients referred to other facilities for cardiac catheterization procedures or open heart surgery procedures, by type of procedure; and (E) the number of diagnostic and therapeutic cardiac catheterization procedures performed during the twelve month period reflected in the PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2015 most recent licensure form on file with the Division of Facility Services; (3) the number of cardiac catheterization patients, classified by adult diagnostic, adult therapeutic and pediatric, from the proposed cardiac catheterization service area that the applicant proposes to serve by patient's county of residence in each of the first three years of operation, including the methodology and assumptions used for these projections; (4) documentation of the applicant's projected sources of patient referrals that are located in the proposed cardiac catheterization service area, including letters from the referral sources that demonstrate their intent to refer patients to the applicant for cardiac catheterization procedures; (5) evidence of the applicant's capability to communicate with emergency transportation agencies and with an established comprehensive cardiac services program; (6) the number and composition of cardiac catheterization teams available to the applicant; (7) documentation of the applicant's in-service training or continuing education programs for cardiac catheterization team members; (8) a written agreement with a comprehensive cardiac services program that specifies the arrangements for referral and transfer of patients seen by the applicant and that includes a process to alleviate the need for duplication in cardiac catheterization procedures; (9) a written description of patient selection criteria including referral arrangements for high-risk patients; (10) a copy of the contractual arrangements for the acquisition of the proposed cardiac catheterization equipment or cardiac angioplasty equipment including itemization of the cost of the equipment; and (11) documentation that the cardiac catheterization equipment and cardiac angioplasty equipment and the procedures for operation of the equipment are designed and developed based on the American College of Cardiology/American Heart Association Guidelines for Cardiac Catheterization Laboratories (1991) American College of Cardiology/ Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards (June 2001) report. Authority G.S. 131E-177(1); 131E-183. 10A NCAC 14C .1603 PERFORMANCE STANDARDS (a) An applicant shall demonstrate that the project is capable of meeting the following standards: (1) each proposed item of cardiac catheterization equipment or cardiac angioplasty equipment, including mobile equipment but excluding shared fixed cardiac catheterization or angioplasty equipment, shall be utilized at an annual rate of at least 60 percent of capacity excluding procedures not defined as cardiac catheterization procedures in 10A NCAC 14C .1601(5), measured during the fourth quarter of the third year following completion of the project; (2) if the applicant proposes to perform therapeutic cardiac catheterization procedures, each of the applicant's therapeutic cardiac catheterization teams shall be performing at an annual rate of at least 100 therapeutic cardiac catheterization procedures, during the third year of operation following completion of the project; (3) if the applicant proposes to perform diagnostic cardiac catheterization procedures, each diagnostic cardiac catheterization team shall be performing at an annual rate of at least 200 diagnostic-equivalent cardiac catheterization procedures by the end of the third year following completion of the project; (4) at least 50 percent of the projected cardiac catheterization procedures shall be performed on patients residing within the primary cardiac catheterization service area; (b) An applicant proposing to acquire mobile cardiac catheterization or mobile cardiac angioplasty equipment shall: (1) demonstrate that each existing item of cardiac catheterization equipment and cardiac angioplasty equipment, excluding mobile equipment, located in the proposed primary cardiac catheterization service area of each host facility shall have been operated at a level of at least 80 percent of capacity during the 12 month period reflected in the most recent licensure form on file with the Division of Facility Services; (2) demonstrate that the utilization of each existing or approved item of cardiac catheterization equipment and cardiac angioplasty equipment, excluding mobile equipment, located in the proposed primary cardiac catheterization service area of each host facility shall not be expected to fall below 60 percent of capacity due to the acquisition of the proposed cardiac catheterization, cardiac angioplasty, or mobile cardiac catheterization equipment; (3) demonstrate that each item of existing mobile equipment operating in the proposed primary cardiac catheterization service area of each host facility shall have been performing at least an average of four diagnostic-equivalent cardiac catheterization procedures per day per site in the proposed cardiac catheterization PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2016 service area in the 12 month period preceding the submittal of the application; (4) demonstrate that each item of existing or approved mobile equipment to be operating in the proposed primary cardiac catheterization service area of each host facility shall be performing at least an average of four diagnostic-equivalent cardiac catheterization procedures per day per site in the proposed cardiac catheterization service area in the applicant's third year of operation; and (5) provide documentation of all assumptions and data used in the development of the projections required in this Rule. (c) An applicant proposing to acquire cardiac catheterization or cardiac angioplasty equipment excluding shared fixed and mobile cardiac catheterization or cardiac angioplasty equipment shall: (1) demonstrate that its existing items of cardiac catheterization and cardiac angioplasty equipment, except mobile equipment, located in the proposed cardiac catheterization service area operated at an average of at least 80% of capacity during the twelve month period reflected in the most recent licensure renewal application form on file with the Division of Facility Services; (2) demonstrate that its existing items of cardiac catheterization equipment or cardiac angioplasty equipment, except mobile equipment, shall be utilized at an average annual rate of at least 60 percent of capacity, measured during the fourth quarter of the third year following completion of the project; and (3) provide documentation of all assumptions and data used in the development of the projections required in this Rule. (d) An applicant proposing to acquire shared fixed cardiac catheterization or cardiac angioplasty equipment as defined in the applicable State Medical Facilities Plan shall: (1) demonstrate that each proposed item of shared fixed cardiac catheterization or cardiac angioplasty equipment shall perform a combined total of at least 225 cardiac catheterization and angiography procedures during the fourth quarter of the third year following completion of the project; and (2) provide documentation of all assumptions and data used in the development of the projections required in this Rule. (e) If the applicant proposes to perform cardiac catheterization procedures on patients age 14 and under, the applicant shall demonstrate that it meets the following additional criteria: (1) the facility has the capability to perform diagnostic and therapeutic cardiac catheterization procedures and open heart surgery services on patients age 14 and under; and (2) the proposed project shall be performing at an annual rate of at least 100 cardiac catheterization procedures on patients age 14 or under during the fourth quarter of the third year following initiation of the proposed cardiac catheterization procedures for patients age 14 and under. Authority G.S. 131E-177(1); 131E-183(b). 10A NCAC 14C .1605 STAFFING AND STAFF TRAINING (a) The applicant shall provide documentation to demonstrate that the following staffing requirements shall be met: (1) one physician licensed to practice medicine in North Carolina who has been designated to serve as director of the cardiac catheterization service and who has all of the following special credentials: (A) board-certified in internal medicine, pediatrics or radiology; (B) subspecialty training in cardiology, pediatric cardiology, or cardiovascular radiology; and (C) current clinical experience in performing physiologic procedures, angiographic procedures, or both; (2) at least one specialized team to perform cardiac catheterizations, composed of at least the following professional and technical personnel: (A) one physician licensed to practice medicine in North Carolina with evidence of training and current experience specifically in cardiovascular disease and radiation sciences; (B) one nurse with training and current experience specifically in critical care of cardiac patients, cardiovascular medication, and catheterization equipment; and (C) at least three two technicians with training specifically in cardiac care who are capable of performing the duties of a radiologic technologist, cardiopulmonary technician, monitoring and recording technician, and darkroom technician. (b) The applicant shall provide documentation to demonstrate that the following staff training shall be provided for members of cardiac catheterization teams: (1) certification in cardiopulmonary resuscitation and advanced cardiac life support; and (2) an organized program of staff education and training which is integral to the cardiac services program and ensures improvements in technique and the proper training of new personnel. Authority G.S. 131E-177(1); 131E-183(b). PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2017 SECTION .1900 – CRITERIA AND STANDARDS FOR RADIATION THERAPY EQUIPMENT 10A NCAC 14C .1901 DEFINITIONS These definitions shall apply to all rules in this Section: (1) "Approved linear accelerator" means a linear accelerator which was not operational prior to the beginning of the review period. (2) "Complex Radiation treatment" is equal to 1.0 ESTV and means: treatment on three or more sites on the body; use of special techniques such as tangential fields with wedges, rotational or arc techniques; or use of custom blocking. (3) "Equivalent Simple Treatment Visit [ESTV]" means one basic unit of radiation therapy which normally requires up to fifteen (15) minutes for the uncomplicated set-up and treatment of a patient on a megavoltage teletherapy unit including the time necessary for portal filming. (4) "Existing linear accelerator" means a linear accelerator in operation prior to the beginning of the review period. (5) "Intermediate Radiation treatment" means treatment on two separate sites on the body, three or more fields to a single treatment site or use of multiple blocking and is equal to 1.0 ESTV. (6) "Linear accelerator" means MRT equipment which is used to deliver a beam of electrons or photons in the treatment of cancer patients. shall have the same meaning as defined in G.S. 131E-176(14g). (7) "Linear accelerator service area" means a single or multi-county area as used in the development of the need determination in the applicable State Medical Facilities Plan. (8) "Megavoltage unit" means MRT equipment which provides a form of teletherapy that involves the delivery of energy greater than, or equivalent to, one million volts by the emission of x-rays, gamma rays, electrons, or other radiation. (9) "Megavoltage radiation therapy (MRT)" means the use of ionizing radiation in excess of one million electron volts in the treatment of cancer. (10) "MRT equipment" means a machine or energy source used to provide megavoltage radiation therapy including linear accelerators and other particle accelerators. (11) "Radiation therapy equipment" means medical equipment which is used to provide radiation therapy services. (12) "Radiation therapy services" means those services which involve the delivery of controlled and monitored doses of radiation to a defined volume of tumor bearing tissue within a patient. Radiation may be delivered to the tumor region by the use of radioactive implants or by beams of ionizing radiation or it may be delivered to the tumor region systemically. (13) "Radiation therapy service area" means a single or multi-county area as used in the development of the need determination in the applicable State Medical Facilities Plan. (14) "Simple Radiation treatment" means treatment on a single site on the body, single treatment field or parallel opposed fields with no more than simple blocks and is equal to 1 ESTV. (15) "Simulator" means a machine that reproduces the geometric relationships of the MRT equipment to the patient. shall have the same meaning as defined in G.S. 131E-176(24b). (16) "Special technique" means radiation therapy treatments that may require increased time for each patient visit including: (a) total body irradiation (photons or electrons) which equals 2.5 ESTVs; (b) hemi-body irradiation which equals 2.0 ESTVs; (c) intraoperative radiation therapy which equals 10.0 ESTVs; (d) neutron and proton radiation therapy which equals 2.0 ESTVs; (e) intensity modulated radiation treatment (IMRT) which equals 2.0 ESTVs; 1.0 ESTV; (f) limb salvage irradiation at lengthened SSD which equals 1.0 ESTV; (g) additional field check radiographs which equals .50 ESTV; (h) stereotactic radiosurgery treatment management with linear accelerator or gamma knife which equals 3.0. ESTVs; and (i) pediatric patient under anesthesia which equals 1.5 ESTVs. Authority G.S. 131E-177(1); 131E-183(b). SECTION .2100 – CRITERIA AND STANDARDS FOR SURGICAL SERVICES AND OPERATING ROOMS 10A NCAC 14C .2101 DEFINITIONS The following definitions shall apply to all rules in this Section: (1) "Ambulatory surgical facility" means a facility as defined in G.S. 131E-176(1b). (2) "Operating room" means an inpatient operating room, an outpatient or ambulatory surgical operating room, or a shared operating room, or an endoscopy procedure room in a licensed health service facility. room. (3) "Ambulatory surgical program" means a program as defined in G.S. 131E-176(1c). (4) "Existing operating rooms" means those operating rooms in ambulatory surgical facilities and hospitals which were reported in PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2018 the License Application for Ambulatory Surgical Facilities and Programs and in Part III of Hospital Licensure Renewal Application Form submitted to the Licensure Section of the Division of Facility Services and which were licensed and certified prior to the beginning of the review period. (5) "Approved operating rooms" means those operating rooms that were approved for a certificate of need by the Certificate of Need Section prior to the date on which the applicant's proposed project was submitted to the Agency but that have not been licensed. and certified. licensed. (6) "Multispecialty ambulatory surgical program" means a program as defined in G.S. 131E- 176(15a). (7) "Outpatient or ambulatory surgical operating room" means an operating room used solely for the performance of surgical procedures which require local, regional or general anesthesia and a period of post-operative observation of less than 24 hours. (8) "Service area" means the Operating Room Service Area as defined in the applicable State Medical Facilities Plan. (9) "Shared operating room" means an operating room that is used for the performance of both ambulatory and inpatient surgical procedures. (10) "Specialty area" means an area of medical practice in which there is an approved medical specialty certificate issued by a member board of the American Board of Medical Specialties and includes, but is not limited to the following: gynecology, otolaryngology, plastic surgery, general surgery, ophthalmology, urology, orthopedics, and oral surgery. (11) "Specialty ambulatory surgical program" means a program as defined in G.S. 131E- 176(24c). (12) "Surgical case" means an individual who receives one or more surgical procedures in an operating room during a single operative encounter. Authority G.S. 131E-177(1); 131E-183(b). 10A NCAC 14C .2103 PERFORMANCE STANDARDS (a) In projecting utilization, the existing, approved and proposed operating rooms shall be considered to be available for use five days per week and 52 weeks a year. (b) A proposal to establish a new ambulatory surgical facility, to increase the number of operating rooms (excluding dedicated C-section operating rooms), to convert a specialty ambulatory surgical program to a multispecialty ambulatory surgical program or to add a specialty to a specialty ambulatory surgical program shall not be approved unless the applicant documents that the average number of surgical cases per operating room to be performed in each facility owned by the applicant in the proposed service area, is reasonably projected to be at least 2.4 surgical cases per day for each inpatient operating room, room (excluding dedicated open-heart and dedicated C-Section operating rooms), 4.8 surgical cases per day for each outpatient or ambulatory surgical operating room, 7.2 cases per day for each endoscopy procedure room, and 3.2 surgical cases per day for each shared operating room during the third year of operation following completion of the project. (c) A proposal to develop an additional operating room to be used as a dedicated C-section operating room shall not be approved unless the applicant documents that the average number of surgical cases per operating room to be performed in each facility owned by the applicant in the proposed service area, is reasonably projected to be at least 2.4 surgical cases per day for each inpatient operating room (excluding dedicated open-heart and dedicated C-section operating rooms), 4.8 surgical cases per day for each outpatient or ambulatory surgical operating room and 3.2 surgical cases per day for each shared operating room during the third year of operation following completion of the project. (d) An applicant proposing to convert a specialty ambulatory surgical program to a multispecialty ambulatory surgical program or to add a specialty to a specialty ambulatory surgical program shall provide documentation to show that each existing ambulatory surgery program in the service area that performs ambulatory surgery in the same specialty area as proposed in the application is currently operating at 4.8 surgical cases per day for each outpatient or ambulatory surgical operating room, 7.2 gastrointestinal endoscopy cases per day for each gastrointestinal endoscopy procedure room, and 3.2 surgical cases per day for each shared operating room. (e) An applicant proposing to convert a specialty ambulatory surgical program to a multispecialty ambulatory surgical program or to add a specialty to a specialty ambulatory surgical program shall provide documentation to show that each existing and approved ambulatory surgery program in the service area that performs ambulatory surgery in the same specialty areas as proposed in the application is reasonably projected to be operating at 4.8 surgical cases per day for each outpatient or ambulatory surgical operating room, 7.2 gastrointestinal endoscopy cases per day for each gastrointestinal endoscopy procedure room, and 3.2 surgical cases per day for each shared surgical operating room prior to the completion of the proposed project. (f) The applicant shall document the assumptions and provide data supporting the methodology used for each projection in this Rule. Authority G.S. 131E-177; 131E-183(b). SECTION .2200 – CRITERIA AND STANDARDS FOR END-STAGE RENAL DISEASE SERVICES 10A NCAC 14C .2203 PERFORMANCE STANDARDS (a) An applicant proposing to establish a new End Stage Renal Disease facility shall document the need for at least 10 stations based on utilization of 3.2 patients per station per week as of the end of the first operating year of the facility. facility, with the exception that the performance standard shall be waived for a need in the State Medical Facilities Plan that is based on an adjusted need determination. PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2019 (b) An applicant proposing to increase the number of dialysis stations in an existing End Stage Renal Disease facility shall document the need for the additional stations based on utilization of 3.2 patients per station per week as of the end of the first operating year of the additional stations with the exception that the performance standard shall be waived for a need in the State Medical Facilities Plan that is based on an adjusted need determination. stations. (c) An applicant shall provide all assumptions, including the specific methodology by which patient utilization is projected. Authority G.S. 131E-177(1); 131E-183(b). SECTION .2500 – CRITERIA AND STANDARDS FOR SUBSTANCE ABUSE/CHEMICAL DEPENDENCY TREATMENT BEDS 10A NCAC 14C .2502 INFORMATION REQUIRED OF APPLICANT (a) An applicant proposing to establish new intensive treatment beds or detoxification beds shall project resident origin by percentage by county of residence. All assumptions and the methodology for projecting occupancy shall be clearly stated. (b) An applicant proposing to establish new intensive treatment beds or detoxification beds shall project an occupancy level for the entire facility for the first eight calendar quarters following the completion of the proposed project, including the average length of stay. All assumptions and the methodology for projecting occupancy shall be clearly stated. (c) If the applicant is an existing chemical dependency treatment facility, the applicant shall document the percentage of patients discharged from the facility that are readmitted to the facility at a later date. (d) An applicant shall document that the following items are currently available or will be made available following completion of the project: (1) admission criteria for clinical admissions to the facility or unit, including procedure for accepting emergency admissions; (2) client evaluation procedures, including preliminary evaluation and establishment of an individual treatment plan; (3) procedures for referral and follow-up of clients to necessary outside services; (4) procedures for involvement of family in counseling process; (5) provision of an aftercare plan; and (6) quality assurance/utilization review plan. (e) An applicant proposing to establish new detoxification beds shall identify the location of each referral source for follow-up outpatient, residential and rehabilitation services located in the proposed service area for clients who have completed detoxification. (f)(e) An applicant shall document the attempts made to establish working relationships with the health care providers and others that are anticipated to refer clients to the proposed intensive treatment and detoxification beds. (g)(f) An applicant shall provide copies of any current or proposed contracts or agreements or letters of intent to develop contracts or agreements for the provision of any services to the clients served in the chemical dependency treatment facility. (h) An applicant shall identify the Area Authority that will serve as the Single Portal of Entry/Exit for the facility. (i)(g) An applicant shall document the provisions that will be made to obtain services for patients with a dual diagnosis of chemical dependency and psychiatric problems. (j)(h) An applicant proposing to establish new intensive treatment beds or detoxification beds shall specify the primary site on which the facility will be located. If such site is neither owned by nor under option by the applicant, the applicant shall provide a written commitment to diligently pursue acquiring the site if and when a certificate of need application is approved, shall specify at least one alternate site on which the facility could be located should acquisition efforts relative to the primary site ultimately fail, and shall demonstrate that the primary site and alternate sites are available for acquisition. (k)(i) An applicant proposing to establish new intensive treatment beds or detoxification beds shall document that the services will be provided in a physical environment that conforms with the requirements in 10A NCAC 27G .0300 which are incorporated by reference including all subsequent amendments. Authority G.S. 131E-177(1); 131E-183. 10A NCAC 14C .2503 PERFORMANCE STANDARDS (a) An applicant shall not be approved unless the overall occupancy, over the nine months immediately preceding the submittal of the application, of the total number of intensive treatment beds and detoxification beds within the facility in which the beds are to be located, located except in facilities with only detoxification beds, has been: (1) 75 percent for facilities with a total of 1-15 intensive treatment beds and detoxification beds; or (2) 85 percent for facilities with a total of 16 or more intensive treatment beds and detoxification beds. (b) An applicant shall not be approved unless the overall occupancy of the total number of intensive treatment beds and detoxification beds to be operated in the facility is projected, projected except in facilities with only detoxification beds, by the fourth quarter of the third year of operation following completion of the project, to be: (1) 75 percent for facilities with a total of 1-15 intensive treatment beds and detoxification beds; or (2) 85 percent for facilities with a total of 16 or more intensive treatment beds and detoxification beds. (c) An applicant proposing to add detoxification beds to an existing facility that includes only detoxification beds shall not be approved unless the overall occupancy of the total number of detoxification beds in the facility has been at least 75 percent for the nine months immediately preceding the submittal of the application. (d) An applicant proposing to establish a new detoxification facility or add detoxification beds to an existing facility that includes only detoxification beds shall demonstrate that the PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2020 overall occupancy of the total number of detoxification beds in the facility is reasonably projected to be 75 percent by the fourth quarter of the third year of operation following completion of the project. (e)(c)The applicant shall document the specific methodology and assumptions by which occupancies are projected, including the average length of stay and anticipated recidivism rate. Authority G.S. 131E-177(1); 131E-183(b). 10A NCAC 14C .2505 STAFFING AND STAFF TRAINING (a) An applicant proposing to establish new intensive treatment beds or detoxification beds shall document that clinical staff members will be: (1) currently licensed or certified by the appropriate state licensure or certification boards; or (2) supervised by staff who are licensed or certified by the appropriate state licensure or certification boards. (b) An applicant proposing to establish new intensive treatment beds or detoxification beds shall document that the staffing pattern in the facility is consistent with the staffing requirements contained in 10A NCAC 27G .3102, .3202, or .3402, which are incorporated by reference including all subsequent amendments. Authority G.S. 131E-177(1); 131E-183. SECTION .2600 – CRITERIA AND STANDARDS FOR PSYCHIATRIC BEDS 10A NCAC 14C .2602 INFORMATION REQUIRED OF APPLICANT (a) An applicant proposing to establish new psychiatric beds shall project resident origin by percentage by county of residence. All assumptions and the methodology for projecting occupancy shall be clearly stated. (b) An applicant proposing to establish new psychiatric beds shall project an occupancy level for the entire facility for the first eight calendar quarters following the completion of the proposed project, including average length of stay. All assumptions and the methodology for projecting occupancy shall be clearly stated. (c) The applicant shall provide documentation of the percentage of patients discharged from the facility that are readmitted to the facility at a later date. (d) An applicant proposing to establish new psychiatric beds shall describe the general treatment plan that is anticipated to be used by the facility and the support services to be provided, including provisions that will be made to obtain services for patients with a dual diagnosis of psychiatric and chemical dependency problems. (e) The applicant shall document the attempts made to establish working relationships with the health care providers and others that are anticipated to refer clients to the proposed psychiatric beds. (f) The applicant shall provide copies of any current or proposed contracts or agreements or letters of intent to develop contracts or agreements for the provision of any services to the clients served in the psychiatric facility. (g) The application shall identify the Area Authority that will serve as the Single Portal of Entry/Exit for the facility. (h)(g) The applicant shall document that the following items are currently available or will be made available following completion of the project: (1) admission criteria for clinical admissions to the facility or unit; (2) emergency screening services for the targeted population which shall include services for handling emergencies on a 24-hour basis or through formalized transfer agreements; (3) client evaluation procedures, including preliminary evaluation and establishment of an individual treatment plan; (4) procedures for referral and follow-up of clients to necessary outside services; (5) procedures for involvement of family in counseling process; (6) comprehensive services which shall include individual, group and family therapy; medication therapy; and activities therapy including recreation; (7) educational components if the application is for child or adolescent beds; (8) provision of an aftercare plan; and (9) quality assurance/utilization review plan. (i)(h) An applicant proposing to establish new psychiatric beds shall specify the primary site on which the facility will be located. If such site is neither owned by nor under option by the applicant, the applicant shall provide a written commitment to diligently pursue acquiring the site if and when a certificate of need application is approved, shall specify at least one alternate site on which the facility could be located should acquisition efforts relative to the primary site ultimately fail, and shall demonstrate that the primary site and alternate sites are available for acquisition. (j)(i) An applicant proposing to establish new psychiatric beds shall provide documentation to show that the services will be provided in a physical environment that conforms with the requirements in 10A NCAC 27G .0300. Authority G.S. 131E-177(1); 131E-183. SECTION .2700 - CRITERIA AND STANDARDS FOR MAGNETIC RESONANCE IMAGING SCANNER 10A NCAC 14C .2701 DEFINITIONS The following definitions shall apply to all rules in this Section: (1) "Approved MRI scanner" means an MRI scanner which was not operational prior to the beginning of the review period but which had been issued a certificate of need. (2) "Capacity of fixed MRI scanner" means 100% of the procedure volume that the MRI scanner is capable of completing in a year, given perfect scheduling, no machine or room downtime, no cancellations, no patient transportation problems, no staffing or PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2021 physician delays and no MRI procedures outside the norm. Annual capacity of a fixed MRI scanner is 6,864 weighted MRI procedures, which assumes two weighted MRI procedures are performed per hour and the scanner is operated 66 hours per week, 52 weeks per year. (3) "Capacity of mobile MRI scanner" means 100% of the procedure volume that the MRI scanner is capable of completing in a year, given perfect scheduling, no machine or room downtime, no cancellations, no patient transportation problems, no staffing or physician delays and no MRI procedures outside the norm. Annual capacity of a mobile MRI scanner is 4,160 weighted MRI procedures, which assumes two weighted MRI procedures are performed per hour and the scanner is operated 40 hours per week, 52 weeks per year. (4) "Dedicated breast MRI scanner" means an MRI scanner that is configured to perform only breast MRI procedures and is not capable of performing other types of non-breast MRI procedures. (4)(5) "Existing MRI scanner" means an MRI scanner in operation prior to the beginning of the review period. (6) "Extremity MRI scanner" means an MRI scanner that is utilized for the imaging of extremities and is of open design with a field of view no greater than 25 centimeters. (5)(7) "Fixed MRI scanner" means an MRI scanner that is not a mobile MRI scanner. (6)(8) "Magnetic Resonance Imaging" (MRI) means a non-invasive diagnostic modality in which electronic equipment is used to create tomographic images of body structure. The MRI scanner exposes the target area to nonionizing magnetic energy and radio frequency fields, focusing on the nuclei of atoms such as hydrogen in the body tissue. Response of selected nuclei to this stimulus is translated into images for evaluation by the physician. (7)(9) "Magnetic resonance imaging scanner" (MRI Scanner) is defined in G.S. 131E-176(14e). (8)(10) "Mobile MRI region" means either the eastern part of the State which includes the counties in Health Service Areas IV, V and VI, VI (Eastern Mobile MRI Region), or the western part of the State which includes the counties in Health Service Areas I, II, and III. III (Western Mobile MRI Region). The counties in each Health Service Area are identified in Appendix A of the State Medical Facilities Plan. (9)(11) "Mobile MRI scanner" means an MRI scanner and transporting equipment which is moved at least weekly to provide services at two or more host facilities. (10)(12) "MRI procedure" means a single discrete MRI study of one patient. (11)(13) "MRI service area" means the Magnetic Resonance Imaging Planning Areas, as defined in the applicable State Medical Facilities Plan, except for proposed new mobile MRI scanners for which the service area is a mobile MRI region. (12)(14) "MRI study" means one or more scans relative to a single diagnosis or symptom. (13) "Pediatric MRI patient" means a patient requiring an MRI scan who is under the age of 12 years or who is a special needs patient and is under the age of 21 years. (14)(15) "Related entity" means the parent company of the applicant, a subsidiary company of the applicant (i.e., the applicant owns 50% or more of another company), a joint venture in which the applicant is a member, or a company that shares common ownership with the applicant (i.e., the applicant and another company are owned by some of the same persons). (15) "Special Needs patient" means a patient who has cerebral palsy, encephalomyelopathy, central nervous system injuries, genetic and metabolic disorders, autism, and mental retardation. (16) "Temporary MRI scanner" means a an MRI scanner that the Certificate of Need Section has approved to be temporarily located in North Carolina at a facility that holds a certificate of need for a new fixed MRI scanner, but which is not operational because the project is not yet complete. (17) "Weighted MRI procedures" means MRI procedures which are adjusted to account for the length of time to complete the procedure, based on the following weights: one outpatient MRI procedure without contrast or sedation is valued at 1.0 weighted MRI procedure, one outpatient MRI procedure with contrast or sedation is valued at 1.4 weighted MRI procedures, one inpatient MRI procedure without contrast or sedation is valued at 1.4 weighted MRI procedures; and one inpatient MRI procedure with contrast or sedation is valued at 1.8 weighted MRI procedures. (18) "Weighted breast MRI procedures" means MRI procedures which are performed on a dedicated breast MRI scanner and are adjusted to account for the length of time to complete the procedure, based on the following weights: one diagnostic breast MRI procedure is valued at 1.0 weighted MRI procedure (based on an average of 60 minutes per procedure), one MRI-guided breast needle localization MRI procedure is valued at 1.1 weighted MRI procedure (based on an average of 66 minutes per procedure), and one MRI-guided breast PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2022 biopsy procedure is valued at 1.6 weighted MRI procedures (based on an average of 96 minutes per procedure). Authority G.S. 131E-177(1); 131E-183(b). 10A NCAC 14C .2702 INFORMATION REQUIRED OF APPLICANT (a) An applicant proposing to acquire an MRI scanner, including a mobile MRI scanner, shall use the Acute Care Facility/Medical Equipment application form. (b) Except for proposals to acquire mobile MRI scanners that serve two or more host facilities, both the applicant and the person billing the patients for the MRI service shall be named as co-applicants in the application form. (c) An applicant proposing to acquire a magnetic resonance imaging scanner, including a mobile MRI scanner, shall provide the following information: (1) documentation that the proposed fixed MRI scanner, excluding fixed extremity and breast MRI scanners, shall be available and staffed for use at least 66 hours per week; (2) documentation that the proposed mobile MRI scanner shall be available and staffed for use at least 40 hours per week; (3) documentation that the proposed fixed extremity or dedicated breast MRI scanner shall be available and staffed for use at least 40 hours per week; (3)(4) the average charge to the patient, regardless of who bills the patient, for each of the 20 most frequent MRI procedures to be performed for each of the first three years of operation after completion of the project and a description of items included in the charge; if the professional fee is included in the charge, provide the dollar amount for the professional fee; (4)(5) if the proposed MRI service will be provided pursuant to a service agreement, the dollar amount of the service contract fee billed by the applicant to the contracting party for each of the first three years of operation; (5)(6) letters from physicians indicating their intent to refer patients to the proposed magnetic resonance imaging scanner and their estimate of the number of patients proposed to be referred per year; year, which is based on the physicians' historical number of referrals; (7) for each location at which the applicant or a related entity will provide MRI services, utilizing existing, approved, or proposed MRI scanners, projections of the annual number of unweighted MRI procedures to be performed for each of the four types of MRI procedures, as identified in the SMFP, for each of the first three years of operation after completion of the project; (6)(8) for each location at which the service will be provided, applicant or a related entity will provide services, utilizing existing, approved, or proposed MRI scanners, projections of the annual number of weighted MRI procedures to be performed for each of the four types of weighted MRI procedures, as identified in the SMFP, for each of the first three years of operation after completion of the project; (7)(9) a detailed description of the methodology and assumptions used to project the number of unweighted weighted MRI procedures to be performed; performed at each location, including the number of contrast versus non-contrast procedures, sedation versus non-sedation procedures, and inpatient versus outpatient procedures; (8)(10) documentation to support each assumption used in projecting the number of procedures to be performed; a detailed description of the methodology and assumptions used to project the number of weighted MRI procedures to be performed at each location; (9)(11) for each existing fixed or mobile MRI scanner owned by the applicant or a related entity and operated in North Carolina in the month the application is submitted, the vendor, tesla strength, serial number or vehicle identification number, CON project identification number, physical location for fixed MRI scanners, and host sites for mobile MRI scanners; (10)(12) for each approved fixed or mobile MRI scanner to be owned by the applicant or a related entity and approved to be operated in North Carolina, the proposed vendor, proposed tesla strength, CON project identification number, physical location for fixed MRI scanners, and host sites for mobile MRI scanners; (11)(13) if proposing to acquire a mobile MRI scanner, an explanation of the basis for selection of the proposed host sites if the host sites are not located in MRI service areas that lack a fixed MRI scanner; and (14) identity of the accreditation authority the applicant proposes to use. (d) An applicant proposing to acquire a mobile MRI scanner shall provide copies of letters of intent from, and proposed contracts with, all of the proposed host facilities of the new MRI scanner. (e) An applicant proposing to acquire a dedicated fixed breast MRI scanner shall: shall demonstrate that: (1) provide a copy of a contract or working agreement with a radiologist or practice group that has experience interpreting images and is trained to interpret images produced by an MRI scanner configured exclusively for mammographic studies; (2) document that the applicant performed mammograms without interruption in the PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2023 provision of the service during the last year; and (3) document that the applicant's existing mammography equipment is in compliance with the U.S. Food and Drug Administration Mammography Quality Standards Act. (1) it has an existing and ongoing working relationship with a specialized breast–imaging radiologist or radiology practice group that has experience interpreting breast images provided by mammography, ultrasound, and MRI scanner equipment, and that is trained to interpret images produced by a MRI scanner configured exclusively for mammographic studies; (2) for the last 12 months it has performed the following services, without interruption in the provision of these services: breast MRI procedures on a fixed MRI scanner with a breast coil, mammograms, breast ultrasound procedures, breast needle core biopsies, breast cyst aspirations, and pre-surgical breast needle localizations; (3) its existing mammography equipment, breast ultrasound equipment, and the proposed dedicated breast MRI scanner is in compliance with the federal Mammography Quality Standards Act; (4) it is part of an existing healthcare system that provides comprehensive cancer care, including radiation oncology, medical oncology, surgical oncology and an established breast cancer treatment program that is based in the geographic area proposed to be served by the applicant; and (5) it has an existing relationship with an established collaborative team for the treatment of breast cancer that includes, radiologists, pathologists, radiation oncologists, hematologists/oncologists, surgeons, obstetricians/gynecologists, and primary care providers. (f) An applicant proposing to acquire a dedicated fixed pediatric an extremity MRI scanner, pursuant to a need determination in the State Medical Facilities Plan for a demonstration project, shall: (1) provide a copy of a contract or working agreement with two pediatric radiologists qualified as described in 10A NCAC 14C .2705(f)(1); (2) provide a copy of the facility's emergency plan for pediatric and special needs patients that outline all emergency procedures including acute care transfers and a copy of a contract with an ambulance service for transportation during any emergencies; (3) commit that the proposed MRI scanner shall be used exclusively to perform procedures on pediatric MRI patients; (4) provide a description of the scope of the research studies that shall be conducted to develop protocols related to MRI scanning of pediatric MRI patients; which includes special needs patients, and (5) commit to prepare an annual report, to be submitted to the Medical Facilities Planning Section and the Certificate of Need Section, which shall include the protocols for scanning pediatric MRI patients and the annual volume of weighted MRI procedures performed, by type. (1) provide a detailed description of the scope of the research studies that shall be conducted to demonstrate the convenience, cost effectiveness and improved access resulting from utilization of extremity MRI scanning; (2) provide projections of estimated cost savings from utilization of an extremity MRI scanner based on comparison of "total dollars received per procedure" performed on the proposed scanner in comparison to "total dollars received per procedure" performed on whole body scanners; (3) provide projections of estimated cost savings to the patient from utilization of an extremity MRI scanner; (4) commit to prepare an annual report at the end of each of the first three operating years, to be submitted to the Medical Facilities Planning Section and the Certificate of Need Section, that shall include: (A) a detailed description of the research studies completed, (B) a description of the results of the studies, (C) the cost per procedure to the patient and billing entity, (D) the cost savings to the patient attributed to utilization of an extremity MRI scanner, (E) an analysis of "total dollars received per procedure" performed on the extremity MRI scanner in comparison to "total dollars received per procedure" performed on whole body scanners; and (F) the annual volume of unweighted and weighted MRI procedures performed, by CPT code; (5) identify the operating hours of the proposed scanner; (6) provide a description of the capabilities of the proposed scanner; (7) provide documentation of the capacity of the proposed scanner based on the number of days to be operated each week, the number of days to be operated each year, the number of hours to be operated each day, and the average PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2024 number of unweighted MRI procedures the scanner is capable of performing each hour; (8) identify the types of MRI procedures by CPT code that are appropriate to be performed on an extremity MRI scanner as opposed to a whole body MRI scanner; (9) provide copies of the operational and safety requirements set by the manufacturer; and (10) describe the specific criteria and methodology to be implemented for utilization review to ensure the medical necessity of the procedures performed. Authority G.S. 131E-177(1); 131E-183(b). 10A NCAC 14C .2703 PERFORMANCE STANDARDS (a) An applicant proposing to acquire a mobile magnetic resonance imaging (MRI) scanner shall: (1) demonstrate that each existing mobile MRI scanner which the applicant or a related entity owns a controlling interest in and operates in the mobile MRI region in which the proposed equipment will be located, except temporary MRI scanners, performed 3,328 weighted MRI procedures in the most recent 12 month period for which the applicant has data. data [Note: This is not the average number of weighted MRI procedures performed on all of the applicant's mobile MRI scanners.]; with the exception that in the event an existing mobile MRI scanner has been in operation less than 12 months at the time the application is filed, the applicant shall demonstrate that this mobile MRI scanner performed an average of at least 277 weighted MRI procedures per month for the period in which it has been in operation; (2) demonstrate annual utilization in the third year of operation is reasonably projected to be at least 3328 weighted MRI procedures on each of the existing, approved and proposed mobile MRI scanners owned by the applicant or a related entity to be operated in the mobile MRI region in which the proposed equipment will be located. [Note: This is not the average number of weighted MRI procedures performed on all of the applicant's mobile MRI scanners.]; (3) document the assumptions and provide data supporting the methodology used for each projection required in this Rule. (b) An applicant proposing to acquire a fixed magnetic resonance imaging (MRI) scanner, except for fixed MRI scanners described in Paragraphs (c) and (d) of this Rule, shall: (1) demonstrate that the existing fixed MRI scanners which the applicant or a related entity owns a controlling interest in and locates in the proposed MRI service area performed an average of 3,328 weighted MRI procedures in the most recent 12 month period for which the applicant has data; (2) demonstrate that each existing mobile MRI scanner which the applicant or a related entity owns a controlling interest in and operates in the proposed mobile MRI region, MRI service area except temporary MRI scanners, performed 3,328 weighted MRI procedures in the most recent 12 month period for which the applicant has data. [Note: This is not the average number of weighted MRI procedures performed on all of the applicant's mobile MRI scanners.]; (3) demonstrate that the average annual utilization of the existing, approved and proposed fixed MRI scanners which the applicant or a related entity owns a controlling interest in and locates in the proposed MRI service area are reasonably expected to perform the following number of weighted MRI procedures, whichever is applicable, in the third year of operation following completion of the proposed project: (A) 1,716 weighted MRI procedures in MRI service areas in which the SMFP shows no fixed MRI scanners are located, (B) 3,775 weighted MRI procedures in MRI service areas in which the SMFP shows one fixed MRI scanner is located, (C) 4,118 weighted MRI procedures in MRI service areas in which the SMFP shows two fixed MRI scanners are located, (D) 4,462 weighted MRI procedures in MRI service areas in which the SMFP shows three fixed MRI scanners are located, or (E) 4,805 weighted MRI procedures in MI MRI service areas in which the SMFP shows four or more fixed MRI scanners are located; (4) if the proposed MRI scanner will be located at a different site from any of the existing or approved MRI scanners owned by the applicant or a related entity, demonstrate that the annual utilization of the proposed fixed MRI scanner is reasonably expected to perform the following number of weighted MRI procedures, whichever is applicable, in the third year of operation following completion of the proposed project: (A) 1,716 weighted MRI procedures in MRI service areas in which the SMFP shows no fixed MRI scanners are located, (B) 3,775 weighted MRI procedures in MRI service areas in which the SMFP shows one fixed MRI scanner is located, PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2025 (C) 4,118 weighted MRI procedures in MRI service areas in which the SMFP shows two fixed MRI scanners are located, (D) 4,462 weighted MRI procedures in MRI service areas in which the SMFP shows three fixed MRI scanners are located, or (E) 4,805 weighted MRI procedures in MRI service areas in which the SMFP shows four or more fixed MRI scanners are located; (4)(5) demonstrate that annual utilization of each existing, approved and proposed mobile MRI scanner which the applicant or a related entity owns a controlling interest in and locates in the proposed MRI service area is reasonably expected to perform 3,328 weighted MRI procedures in the third year of operation following completion of the proposed project. [Note: This is not the average number of weighted MRI procedures to be performed on all of the applicant's mobile MRI scanners.]; (5)(6) document the assumptions and provide data supporting the methodology used for each projection required in this Rule. (c) An applicant proposing to acquire a fixed dedicated breast magnetic resonance imaging (MRI) scanner for which the need determination in the State Medical Facilities Plan was based on an approved petition for an adjustment to the need determination shall: (1) demonstrate annual utilization of the proposed MRI scanner in the third year of operation is reasonably projected to be at least 1,716 1,664 weighted MRI procedures per year; which is .80 X 1 procedure per hour X 40 hours per week X 52 weeks per year; and (2) document the assumptions and provide data supporting the methodology used for each projection required in this Rule. (d) An applicant proposing to acquire a dedicated fixed pediatric a fixed extremity MRI scanner for which the need determination in the State Medical Facilities Plan was based on an approved petition for an adjustment to the need determination shall: (1) demonstrate annual utilization of the proposed MRI scanner in the third year of operation is reasonably projected to be at least 2746 weighted MRI procedures (i.e., 80 percent of one procedure per hour, 66 hours per week, 52 weeks per year); 80 percent of the capacity defined by the applicant in response to 10A NCAC 14C .2702(f)(6), and (2) document the assumptions and provide data supporting the methodology used for each projection required in this Rule. Authority G.S. 131E-177(1); 131E-183(b). 10A NCAC 14C .2704 SUPPORT SERVICES (a) An applicant proposing to acquire a mobile MRI scanner shall provide referral agreements between each host site and at least one other provider of MRI services in the proposed MRI service area geographic area to be served by the host site, to document the availability of MRI services if patients require them when the mobile unit is not in service at that host site. (b) An applicant proposing to acquire a dedicated fixed pediatric MRI scanner shall provide a written policy regarding pediatric sedation which outlines the criteria for sedating a pediatric patient, including the special needs patients, and identifies the staff that will administer and supervise the sedation process. (c) An applicant proposing to acquire a dedicated fixed pediatric MRI scanner shall provide evidence of the availability of a pediatric code cart at the facility where the proposed pediatric MRI scanner will be located and a plan for emergency situations as described in 10A NCAC 14C .2702(f)(2). (d)(b) An applicant proposing to acquire a fixed or mobile MRI scanner shall obtain accreditation from the Joint Commission for the Accreditation of Healthcare Organizations, the American College of Radiology or a comparable accreditation authority, as determined by the Certificate of Need Section, for magnetic resonance imaging within two years following operation of the proposed MRI scanner. Authority G.S. 131E-177(1); 131E-183(b). 10A NCAC 14C .2705 STAFFING AND STAFF TRAINING (a) An applicant proposing to acquire an MRI scanner, including extremity and breast MRI scanners, shall demonstrate that one diagnostic radiologist certified by the American Board of Radiologists shall be available to provide the proposed services interpret the images who has had: (1) training in magnetic resonance imaging as an integral part of his or her residency training program; or (2) six months of supervised MRI experience under the direction of a certified diagnostic radiologist; or (3) at least six months of fellowship training, or its equivalent, in MRI; or (4) a combination of MRI experience and fellowship training equivalent to Subparagraph (a)(1), (2) or (3) of this Rule. (b) An applicant proposing to acquire a dedicated fixed breast MRI scanner shall provide documentation that that: the radiologist is trained and has experience in interpreting images produced by an MRI scanner configured exclusively to perform mammographic studies. (1) the radiologist is trained and has specific expertise in breast imaging, including mammography, breast ultrasound and breast MRI procedures; and (2) two full time MRI technologists or two mammography technologists are available with specialized training in breast MRI imaging and that one of these technologists shall be present during the hours operation of the dedicated breast MRI scanner. PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2026 (c) An applicant proposing to acquire a MRI scanner, including extremity but excluding dedicated breast MRI scanners, shall provide evidence of the availability of two full-time MRI technologist-radiographers and that one of these technologists shall be present during the hours of operation of the MRI scanner. (d) An applicant proposing to acquire an MRI scanner, including extremity and breast MRI scanners, shall demonstrate that the following staff training is provided: (1) American Red Cross or American Heart Association certification in cardiopulmonary resuscitation (CPR) and basic cardiac life support; and (2) the availability of an organized program of staff education and training which is integral to the services program and ensures improvement in technique and the proper training of new personnel. (e) An applicant proposing to acquire a mobile MRI scanner shall document that the requirements in Paragraphs Paragraph (a) and (c) of this Rule shall be met at each host facility. facility, and that one full time MRI technologist-radiographer shall be present at each host facility during all hours of operation of the proposed mobile MRI scanner. (f) An applicant proposing to acquire a dedicated fixed pediatric an extremity MRI scanner scanner, pursuant to a need determination in the State Medical Facilities Plan for a demonstration project, also shall provide: (1) provide documentation of the availability of at least two radiologists, certified by the American Board of Radiology, with a pediatric fellowship or two years of specialized training in pediatrics; (2)(1) provide evidence that the applicant will have at least one licensed physician shall be on-site during the hours of operation of the proposed MRI scanner; (3) provide documentation that the applicant will employ at least two licensed registered nurses and that one of these nurses shall be present during the hours of operation of the proposed MRI scanner; (4)(2) provide a description of a research group for the project including a radiologist, neurologist, pediatric sedation specialist orthopaedic surgeon, and research coordinator; and (5) provide documentation of the availability of the research group to conduct research studies on the proposed MRI scanner; and (6)(3) provide letters from the proposed members of the research group indicating their qualifications, experience and willingness to participate on the research team. (g) An applicant proposing to perform cardiac MRI procedures shall provide documentation of the availability of a radiologist, certified by the American Board of Radiology, with training and experience in interpreting images produced by an MRI scanner configured to perform cardiac MRI studies. Authority G.S. 131E-177(1); 131E-183(b). SECTION .2800 - CRITERIA AND STANDARDS FOR REHABILITATION SERVICES 10A NCAC 14C .2801 DEFINITIONS The definitions in this Rule will apply to all rules in this Section. (1) "Rehabilitation Facility" means a facility as defined in G.S. 131E-176. (2) "Rehabilitation" means the process to maintain, restore or increase the function of disabled individuals so that an individual can live in the least restrictive environment, consistent with his or her objective. (3) "Outpatient Rehabilitation Clinic" is defined as a program of coordinated and integrated outpatient services, evaluation, or treatment with emphasis on improving the functional level of the person in coordination with the patient's family. (4) "Rehabilitation Beds" means inpatient beds for which a need determination is set forth in 10 NCAC 14B the current State Medical Facilities Plan and which are located in a hospital licensed pursuant to G.S. 131E-77 or a nursing facility licensed pursuant to G.S. 131E-102. G.S. 131E-77. (5) "Traumatic Brain Injury" is defined as an insult to the brain that may produce a diminished or altered state of consciousness which results in impairment of cognitive abilities or physical functioning. It can also result in the disturbance of behavioral or emotional functioning. These impairments may be either temporary or permanent and cause partial or total functional disability or psychological maladjustment. (6) "Stroke" (cerebral infarction, hemorrhage) is defined as the sudden onset of a focal neurologic deficit due to a local disturbance in the blood supply to the brain. (7) "Spinal Cord Injury" is defined as an injury to the spinal cord that results in the loss of motor or sensory function. (8) "Pediatric Rehabilitation" is defined as inpatient rehabilitation services provided to persons 14 years of age or younger. Authority G.S. 131E-177; 131E-183(b). 10A NCAC 14C .2806 QUALITY OF SERVICES A proposal to add rehabilitation beds to an existing facility shall document that the facility has not operated on a provisional license beyond the effective date of the initial provisional license issued for a new operator, received an administrative penalty or had its admissions suspended within the 18 month period immediately preceding the submittal of the certificate of need application. Authority G.S. 131E-177; 131E-183(b). PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2027 SECTION .3500 - CRITERIA AND STANDARDS FOR ONCOLOGY TREATMENT CENTERS 10A NCAC 14C .3501 DEFINITIONS The following definitions shall apply to all rules in this section: (1) "Major medical equipment" is defined in G.S. 131E-176(14f). (2) "Medical equipment" means equipment used by the oncology treatment center to diagnose or treat disease or injury in patients, including major medical equipment. (3) "Medical oncologist" is a physician with a special interest in and competence in managing patients with cancer. (4) "Medicine-Oncology" means a clinical medical specialty with a specific involvement with the treatment of tumors. (5) "Oncology diagnostic services" means those services which include, but are not limited to, procedures using diagnostic radiology and imaging techniques, clinical and pathological laboratory tests, or physical examination to obtain information from which a diagnosis is established. (6) "Oncology evaluation services" means the compilation of all diagnostic test results and consultation reports for the development of a patient specific treatment plan to provide curative or palliative cancer treatment. (7) "Oncology treatment center" is defined in G.S. 131E-176(18a). (8) "Oncology treatment center service area" means the geographic area defined by the applicant from which patients will originate who will receive the health services proposed. (9) "Oncology treatment services" means curative or palliative services provided to cancer patients which involve the use of radiation therapy, chemotherapy or other treatment techniques. (10) "Radiation oncologist" means a medical physician with a special interest, training and competence in managing patients with cancer who is certified by the American Board of Radiology or its equivalent. (11) "Radiology-Oncology" means a clinical medical specialty involving the treatment of tumors, particularly as they relate to treatment with ionizing radiation. Authority G.S. 131E-177(1); 131E-183(b). 10A NCAC 14C .3502 INFORMATION REQUIRED OF APPLICANT (a) An applicant proposing to develop a new oncology treatment center shall use the Acute Care Facility/Medical Equipment application form. (b) An applicant shall also submit the following additional information: (1) documentation of the number of existing oncology treatment centers and other health service facilities which provide similar services in the proposed oncology treatment center's service area; (2) a list of the medical/surgical specialties in the existing oncology treatment centers and other health service facilities which provide similar services in the proposed oncology treatment center service area, such as Radiation- Oncology, Medicine-Oncology, and surgical specialties; (3) a list of the medical equipment that is proposed to be acquired; (4) documentation verifying the actual cost or market value of each item of medical equipment, whichever is greater; (5) documentation that the proposed services shall result in an integrated multidisciplinary effort to diagnose and treat patients' clinical and psychosocial needs; (6) a list of all oncology diagnostic, oncology evaluation, and oncology treatment services that shall be available, and documentation demonstrating the means by which these services shall be provided; (7) documentation that coordination and referral agreements exist with a hospital, referring physicians, and surgical and medical specialists and subspecialists; and (8) documentation that the services shall be offered in a physical environment that conforms to the requirements of federal, state, and local regulatory bodies. (c) An applicant proposing to acquire radiation therapy equipment shall document compliance with 10A NCAC 14C .1900, Criteria and Standards for Radiation Therapy Equipment. (d) An applicant proposing to develop a new oncology treatment center shall provide: (1) the number of patients that are projected to use the service, by diagnosis; (2) the number of patients that are projected to use the service, by county of residence; (3) documentation of the maximum number of procedures that the equipment in the facility is capable of performing and the assumptions used to determine the maximum number of procedures; (4) quarterly projected utilization of the applicant's new equipment for each of the first three years after the completion of the project; (5) documentation of the effect the new oncology treatment center may have on existing oncology treatment centers and other health service facilities which provide similar services in the proposed oncology treatment center service area; and (6) all the assumptions and data supporting the methodology used to make the above projections. PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2028 Authority G.S. 131E-177(1); 131E-183. 10A NCAC 14C .3504 SUPPORT SERVICES (a) An applicant proposing to develop an oncology treatment center shall document that the following services will be available to the center: (1) medical oncology services; (2) radiation oncology services; (3) diagnostic radiology services; (4) nuclear medicine services; (5) hospice and home health services; (6) psychology and social services; (7) pharmaceutical services; (8) pathology services; (9) transportation services; and (10) tumor registry services. (b) An applicant proposing to develop an oncology treatment center shall specify whether any services other than those listed in Paragraph (a) of this Rule will be available to the center and shall list those additional services. (c) An applicant proposing to develop an oncology treatment center shall list the types of surgical specialties which will be available to the center. (d) An applicant proposing to develop an oncology treatment center for the provision of medical-oncology services shall document that the following services will be available in the center: (1) pharmaceutical services; and (2) pathology services. (e) An applicant proposing to develop an oncology treatment center for the provision of radiation-oncology services shall document that diagnostic radiology services will be available in the center. Authority G.S. 131E-177(1); 131E-183(b). 10A NCAC 14C .3505 STAFFING AND STAFF TRAINING An applicant proposing to establish a new oncology treatment center shall provide the following information: (1) the medical specialties and board certification status of each physician who will provide services in the proposed center. An applicant shall also provide documentation of at least the following types of physicians: (a) if proposing radiation-therapy services, a radiation oncologist; (b) if proposing radiation-therapy services, access to a medical oncologist; (2) a description of the special training and specialty certification which will be required of all registered nurses who will be employed by the center; (3) documentation to show the types and numbers of staff, particularly qualified medical technologists and medical staff, that shall be available to support the services and an explanation as to why these staff are adequate to provide the proposed services; and (4) documentation to demonstrate that a formal training program exists to ensure the continued proficiency of the professional and technical staff. Authority G.S. 131E-177(1); 131E-183(b). SECTION .3700 - CRITERIA AND STANDARDS FOR POSITRON EMISSION TOMOGRAPHY SCANNER 10A NCAC 14C .3702 INFORMATION REQUIRED OF APPLICANT (a) An applicant proposing to acquire a PET scanner, including a mobile PET scanner, shall use the Acute Care Facility/Medical Equipment application form. (b) An applicant proposing to acquire a PET scanner, including a mobile PET scanner, shall provide the following information for each facility where the PET scanner will be operated: (1) The projected number of procedures to be performed and the projected number of patients to be served for each of the first three years following completion of the proposed project. Projections shall be listed by clinical area (e.g., oncology, cardiology), and all methodologies and assumptions used in making the projections shall be provided. (2) Documentation that all of the following services were provided, at each facility where the PET scanner will be operated, continuously throughout the 12 months immediately prior to the date on which the application is filed: (A) nuclear medicine imaging services; (B) single photon emission computed tomography (including brain, bone, liver, gallium and thallium stress); (C) magnetic resonance imaging scans; (D) computerized tomography scans; (E) cardiac angiography; (F) cardiac ultrasound; and (G) neuroangiography. (3) Documentation that the facility will: (A) establish the clinical PET unit, and any accompanying equipment used in the manufacture of positron-emitting radioisotopes, as a regional resource that will have no administrative, clinical or charge requirements that would impede physician referrals of patients for whom PET testing would be appropriate; and (B) provide scheduled hours of operation for the PET scanner of a minimum of 12 hours per day, six days a week, except for mobile scanners; and scanners. (C) implement a referral system which shall include a feedback mechanism PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2029 of providing patient information to the referring physician and facility. (4) A description of the protocols that will be established to assure that all clinical PET procedures performed are medically necessary and cannot be performed using other, less expensive, established modalities. (c) An applicant proposing to acquire a mobile PET scanner shall provide copies of letters of intent from and proposed contracts with all of the proposed host facilities at which the mobile PET scanner will be operated. (d) An applicant proposing to acquire a mobile PET scanner shall demonstrate that each host facility offers or contracts with a hospital that offers comprehensive cancer services including radiation oncology, medical oncology, and surgical oncology. (e) An applicant shall document that all equipment, supplies and pharmaceuticals proposed for the service have been certified for use by the U.S. Food and Drug Administration or will be used under an institutional review board whose membership is consistent with U.S. Department of Health and Human Services' regulations. (f) An applicant shall document that each PET scanner and cyclotron shall be operated in a physical environment that conforms to federal standards, manufacturers manufacturer's specifications, and licensing requirements. The following shall be addressed: (1) quality control measures and assurance of radioisotope production of generator or cyclotron-produced agents; (2) quality control measures and assurance of PET tomograph tomography and associated instrumentation; (3) radiation protection and shielding; (4) radioactive emission to the environment; and (5) radioactive waste disposal. Authority G.S. 131E-177(1); 131E-183(b). 10A NCAC 14C .3703 PERFORMANCE STANDARDS (a) An applicant proposing to acquire a dedicated PET scanner, including a mobile dedicated PET scanner, shall demonstrate that: (1) the proposed dedicated PET scanner, including a proposed mobile dedicated PET scanner, shall be utilized at an annual rate of at least 3,200 2,080 PET procedures by the end of the third year following completion of the project; (2) if an applicant operates an existing dedicated PET scanner, its existing dedicated PET scanners, excluding those used exclusively for research, performed an average of at least 3,200 2,080 PET procedures per PET scanner in the last year; and (3) its existing and approved dedicated PET scanners shall perform an average of at least 3,200 2,080 PET procedures per PET scanner during the third year following completion of the project. (b) The applicant shall describe the assumptions and provide data to support and document the assumptions and methodology used for each projection required in this Rule. Authority G.S. 131E-177(1); 131E-183(b). 10A NCAC 14C .3704 SUPPORT SERVICES (a) An applicant proposing to acquire a PET scanner, including a mobile PET scanner, shall document how medical emergencies within the PET scanner unit will be managed at each facility where the PET scanner will be operated. (b)(a) An applicant proposing to acquire a PET scanner, including a mobile PET scanner, shall document that radioisotopes shall be acquired from one or more of the following sources and shall identify the sources which will be utilized by the applicant: (1) an off-site medical cyclotron and radioisotope production facility that is located within two hours transport time to each facility where the PET scanner will be operated; (2) an on-site rubidium-82 generator; or (3) an on-site medical cyclotron for radio nuclide production and a chemistry unit for labeling radioisotopes. (c)(b) An applicant proposing to acquire an on-site cyclotron for radioisotope production shall document that these agents are not available or cannot be obtained in an economically cost effective manner from an off-site cyclotron located within 2 hours total transport time from the applicant's facility. (d)(c) An applicant proposing to develop new PET scanner services, including mobile PET scanner services, shall establish a clinical oversight committee at each facility where the PET scanner will be operated before the proposed PET scanner is placed in service that shall: (1) develop screening criteria for appropriate PET scanner utilization; (2) review clinical protocols; (3) review appropriateness and quality of clinical procedures; (4) develop educational programs; and (5) oversee the data collection and evaluation activities of the PET scanning service. Authority G.S. 131E-177(1); 131E-183(b). SECTION .3900 - CRITERIA AND STANDARDS FOR GASTROINTESTINAL ENDOSCOPY PROCEDURE ROOMS IN LICENSED HEALTH SERVICE FACILTIES 10A NCAC 14C .3901 DEFINITIONS The following definitions shall apply to all rules in this Section: (1) "Ambulatory surgical facility" means a facility as defined in G.S. 131E-176(1b). (2) "Gastrointestinal (GI) endoscopy room" means a room as defined in G.S. 131E-176(7d) that is used to perform one or more GI endoscopy procedures. (3) "Gastrointestinal (GI) endoscopy procedure" means a single procedure, identified by CPT code or ICD-9-CM procedure code, performed PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2030 on a patient during a single visit to the facility for diagnostic or therapeutic purposes. (4) "Operating room" means a room as defined in G.S. 131E-176(18c). (5) "Related entity" means the parent company of the applicant, a subsidiary company of the applicant (i.e., the applicant owns 50 percent or more of another company), a joint venture in which the applicant is a member, or a company that shares common ownership with the applicant (i.e., the applicant and another company are owned by some of the same persons). (6) "Service area" means the geographical area, as defined by the applicant using county lines, from which the applicant projects to serve patients. Authority G.S. 131E-177(1); 131E-183(b). 10A NCAC 14C .3902 INFORMATION REQUIRED OF APPLICANT (a) An applicant proposing to establish a new licensed ambulatory surgical facility for performance of GI endoscopy procedures or develop a GI endoscopy room in an existing licensed health service facility shall provide the following information: (1) the counties included in the applicant's proposed service area, as defined in 10A NCAC 14C .3906; (2) with regard to services provided in the applicant's GI endoscopy rooms, identify: (A) the number of existing and proposed GI endoscopy rooms in the licensed health service facility in which the proposed rooms will be located; (B) the number of existing or approved GI endoscopy rooms in any other licensed health service facility in which the applicant or a related entity has a controlling interest that is located in the applicant's proposed service area; (C) the number of GI endoscopy procedures, identified by CPT code or ICD-9-CM procedure code, performed in the applicant's licensed or non-licensed GI endoscopy rooms in the last 12 months; (D) the number of GI endoscopy procedures, identified by CPT code or ICD-9-CM procedure code, projected to be performed in the GI endoscopy rooms in each of the first three operating years of the project (E) the number of procedures by type, other than GI endoscopy procedures, performed in the GI endoscopy rooms in the last 12 months; (F) the number of procedures by type, other than GI endoscopy procedures, projected to be performed in the GI endoscopy rooms in each of the first three operating years of the project; (G) the number of patients served in the licensed or non-licensed GI endoscopy rooms in the last 12 months; and, (H) the number of patients projected to be served in the GI endoscopy rooms in each of the first three operating years of the project; (3) with regard to services provided in the applicant's operating rooms identify: (A) the number of existing operating rooms in the facility; (B) the number of procedures by type performed in the operating rooms in the last 12 months; and (C) the number of procedures by type projected to be performed in the operating rooms in each of the first three operating years of the project; (4) the days and hours of operation of the facility in which the GI endoscopy rooms will be located; (5) if an applicant is an existing facility, the type and average facility charge for each of the ten GI endoscopy procedures most commonly performed in the facility during the preceding 12 months; (6) the type and projected average facility charge for the 10 GI endoscopy procedures which the applicant projects will be performed most often in the facility; (7) a list of all services and items included in each charge, and a description of the bases on which these costs are included in the charge; (8) identification of all services and items (e.g., medications, anesthesia) that will not be included in the facility's charges; (9) if an applicant is an existing facility, the average reimbursement received per procedure for each of the ten GI endoscopy procedures most commonly performed in the facility during the preceding 12 months; and (10) the average reimbursement projected to be received for each of the ten GI endoscopy procedures which the applicant projects will be performed most frequently in the facility. (b) An applicant proposing to establish a new licensed ambulatory surgical facility for provision of GI endoscopy procedures shall submit the following information: (1) a copy of written administrative policies that prohibit the exclusion of services to any patient on the basis of age, race, religion, disability or the patient's ability to pay; (2) a written commitment to participate in and comply with conditions of participation in the PROPOSED RULES 20:23 NORTH CAROLINA REGISTER JUNE 1, 2006 2031 Medicare and Medicaid programs within three months after licensure of the facility; (3) a description of strategies to be used and activities to be undertaken by the applicant to assure the proposed services will be accessible by indigent patients without regard to their ability to pay; (4) a written description of patient selection criteria including referral arrangements for high-risk patients; (5) the number of GI endoscopy procedures performed by the applicant in any other existing licensed health service facility in each of the last 12 months, by facility; (6) if the applicant proposes reducing the number of GI endoscopy procedures it performs in existing licensed facilities, the specific rationale for its change in practice pattern. Authority G.S. 131E-177; 131E-183(b). 10A NCAC 14C .3903 PERFORMANCE STANDARDS (a) In providing projections for operating rooms, as required in this rule, the operating rooms shall be considered to be available for use 250 days per year, which is five days per week, 52 weeks per year, excluding ten days for holidays. (b) An applicant proposing to establish a new licensed ambulatory surgical facility for performance of GI endoscopy procedures or develop a GI endoscopy room in an existing licensed health service facility shall reasonably project to perform an average of at least 1,500 GI endoscopy procedures only per GI endoscopy room in each licensed facility the applicant or a related entity owns in the proposed service area, during the second year of operation following completion of the |
OCLC number | 13686205 |