Chapter 02 - Need For Health Facilities and Services

Exhibit 5 - Certificate of Need for Health Services, Facilities, or Equipment


Notification is hereby given that the Review Board, of the Territorial Health Planning Agency of American Samoa, acting under the authority invested in it by P.L. 15-66 and the rules promulgated by the Agency for implementing said law, after due consideration of the information provided by the other interested parties, and the public-at-large, has determined that the proposed project entitled of the is needed in the Territory.

You are hereby authorized to take the necessary steps to implement the above project. (Please note the terms and conditions upon determinations of need described in Part 27 of the Determination of Need Rules).

 

_________________________________________________________

DIRECTOR OF HEALTH PLANNING AND DEVELOPMENT AGENCY

Exhibit 4 - Determination of Need Form


AMERICAN SAMOA

HEALTH PLANNING AND DEVELOPMENT AGENCY

L.B.J. TROPICAL MEDICAL CENTER

FAGA'ALU

 

DETERMINATION OF NEED FORM 100

A. This form is being submitted for

________ Application for determination of need

________ Notice of Intent for Health Facility

or services Project

B. Name of Facility or Organization

C. Project Contact:

Name ____________________________________________________________________Phone____________________________

Address____________________________________________________________________________________________________

D. Type of Project

 

__

_______ Renovation of Facility

_______ Equipment Only

E. Type of Facility

 

_______ Skilled Nursing

_______ Intermediate Care

F. Estimated Cost _________

 

(amounts)

(check all applicable)

 

 

_______ New Facility

_______ Hospital

G. Source of Funds

_____ Expansion of Facility

 

 

_______ Home Health Agency Federal _______________

_______ Addition of Beds _______ Kidney Disease Treatment Center GAS _________________

_______ Deletion of Beds _______ HMO

_______ Change in Bed _______ Ambulatory Health

Classification Care Facility

_______ Addition of Service _______ Other, specify H. Expected Date of

_______ Deletion of Service ____________________________________ Obligation of Funds

____________________________________ ____________________

 

I. Number of beds (if any) to be affected by the project:

____________ added, ________removed _______________ changed from ________ to ________

type type

J. Description of change in services offered :

K. Estimated Project Completion Date : ___________________________________________________

MonthYear

L. Summary Description of the Project and the Need it is Intended to Fill (attach separate sheet if needed)

M. Type of Review Request (see Procedure Manual, Determination of Need Rules)

_________ Standard

_________ Emergency (Explain on an attachment your justification for an emergency review.)

N. Assurance:

To the best of my knowledge the above description of the proposed project and the accompanying supportive information is an accurate representation of the true nature and scope of the project.

_______________________________ _____________________

SIGNATURE DATE

Exhibit 3 - Examples of Fixed Equipment


(a) Building Services Equipment:

Electric lighting and power feed wiring:

Conduit and wiring

Fixtures

Transformers

Switch gear.

Central television antenna systems.

Clock systems.

Communications.

Heating, ventilating, and air conditioning systems:

Air conditioning systems: (all equipment and units)

Large -over 20 tons

Medium -5 to 15 tons

Small -under 5 tons

Boilers

Compressors, air, under 5 HP.

Compressors, air, 7 -1/2 HP and over

Condensate tanks

Condensers

Controls

Coolers and dehumidifiers

Cooling towers

Wood

Metal

Ductwork

Fans, air-handling and ventilating

Filters

Furnaces, domestic-type

Incinerator, indoor

Oil storage tanks

Piping

Precipitators

Pumps

Radiators, cast-iron

Radiators, finned-tube

Unit heaters.

Nurse call systems.

Piping, oxygen, gas, air.

Paging systems.

Plumbing, composite:

Fixtures

Piping

Pumps

Water heaters

Water storage tanks.

Sprinkler and fire protection systems:

Fire alarm systems

Fire pumps

Sprinkler system

Tanks and towers.

Sewerage, composite:

Piping Sump pumps and sewerage ejectors.

Telephone systems.

Vacuum cleaning systems.

(b) Other Fixed Equipment.

Built-in benches, bins, cabinets, counters, shelving.

Conveying systems.

Generator sets.

Hoods, fume.

Sinks and drainboards.

Sterilizers (built-in).

Exhibit 2 - Examples of Major Movable Equipment


Air conditioners.

Analyzers, gas.

Ambulance.

Anesthesia units.

Audiometers.

Auto-analyzers.

Autoclaves.

Automobiles, delivery.

Automobiles, passengers.

Bain maries.

Balances.

Basal metabolism units.

Bassinets, heated.

Baths, paraffin.

Beds, electric.

Beds, manual.

Biochemical analysis units, micro.

Blood processing units.

Breathing units, positive pressure.

Broilers.

Buffer, electric.

Cardiographs.
Cardioscopes.

Carts, food tray, heat-refrig.

Centrifuges.

Chloridometer-titrators, automatic.

Chromatographs, gas.

Cobalt, radioactive.

Coldpack units, floor.

Colorimeters.

Croupettes.

Difibrillators.

Dental treatment units.

Diathermy units.

Disinfectors.

Distilling apparatus.

Drills, press.

Drying ovens, paint shop.

Electrocardiographs.

Electroencephalographs.

Electrophoresis units.

Electrosurgical units.

Examining tables, metal and wood.

Fluoroscopes.

Frames, turning.

Furnaces, laboratory.

High frequency apparatus with diathermy.

Homogenizers.

Hydrocollators, floor.

Illuminator units, multifilm.

Incubators.

Incubators, laboratory.

Kilns.

Kymographs.

Lamps, deep therapy.

Lamps, emergency.

Lamps, infrared.

Lamps, mercury quartz.

Lights, examining.

Lights, portable emergency.

Microfilm units.

Microscopes.

Microprojectors.

Ovens, paraffin.

Ovens, sterilizing.

Oxygen tents, motors, and trucks.

pH meters.
Photometers.

Photrometers.

Pulmotors.

Pumps, vacuum and pressure.

Radiation counters.

Radiographic-fluoroscopic combination.

Respirators.

Resuscitators.

Rinsers, sonic.

Scanners, isotope.

Scintillation scalers.

Seriographs, automatic.

Serological baths.

Shaking machines.

Sharpeners, microtome knife.

Shears, squaring floor.

Spectrometers.

Spectrophometers.

Sterilizer, movable.

Suction pump.

Tables, autopsy.

Tables, metal and wood.

Tables, obstetrical.

Tables, operating.

Tables, therapy.

Tanks, paraffin.

Tents, oxygen.

Tissue processors.

Ultraviolet units.

Vibrators.

Volumetric blood gas apparatus.

Wheelchairs.

X-ray fIlm driers.

X-ray film processors.

X-ray machines, deep therapy.

X-ray machines, mobile.

X-ray machines, superficial therapy.

Exhibit 1 - Standard Categories of Health Care Services


The initiation or implementation of any of the specified health care services, as shown below, which have not been previously provided by the health care facility will require a certificate of need.

(a) Bed-related.

(1) (A) Medicine:

Allergy

Anesthesiology

Dermatology

Endocrinology

Gastroenterology

Cardiac care (Non CCU)

Physical and Medical evaluation

Family practice Internal medicine

Pulmonary function and inhalation therapy

Geriatric

Urology

Eye, ear, nose, throat

Neurology.

(B) Surgery:

General

Ophthalmology

Thoracic

Otorhinolaryngology

Proctology

Orthopedic

Urology

Cystoscopy

Oral

Plastic

Neuro.

(2) Obstetrics, gynecology.

(3) Pediatric.

(4) Intensive care (ICU), including neonatal intensive care unit.

(5) Cardiac care (CCU).

(6) Psychiatric:

Partial hospitalization program

Psychological evaluation

Shock therapy.

(7) Long-term care.

(8) Sheltered care (skilled nursing care, convalescent care).

(b) Nonbed-related.

(1) Outpatient and clinic services:

Allergy

Arthritis

Cardio-vascular

Cystic fibrosis

Dermatology

Diabetes

Endocrinology

Eye, ear, nose, throat

Family planning

Genito-urinary

Glaucoma

Gynecology

Hypertension

Inoculation

Medical

Mental health

Muscular dystrophy

Neurology

Obstetrics

Parasitology

Pediatrics

Podiatry

Psychiatric

Sickle cell anemia

Speech

Hearing

Surgery

Thoracic

Tuberculosis

Tumor/Cancer

Venereal disease

Diagnostic and preventive medicine

Private ambulatory service

Home care program

Outreach clinic

Ambulance service affiliated with a health care facility

(2) Emergency room services.

(3) Diagnostic radiology:

Diagnostic X-ray

Cinefluorography

Ventriculography

Angio-cardiology.

(4) Computerized axial tomography.

(5) Nuclear medicine.

(6) Laboratory services:

Micro biology

Clinical chemistry

Serology

Hematology

Pathology

Histopathology

Autopsy

Basal-metabolism.

(7) Physical medicine:

Physical therapy

Occupational therapy

Speech therapy

Recreational therapy

Audiology Prosthetics, brace fitting.

(8) Dentistry:

Oral surgery

Operative/Restorative dentistry

Endodontia

Prostodontia

Periodontia

Orthodontia

(9) Vocational services

(10) Home health agency.

(11) Drug rehabilitation.

(12) Alcohol rehabilitation.

(13) Freestanding health screening centers.

(c) Special services:

(1) Renal dialysis.

(2) Cardiac catheterization.

(3) Burn center.

(4) Neurosurgery.

(5) Open heart surgery.

(6) Organ transplant.

(7) Therapeutic radiation :

X-ray therapy

Orthovoltage X-ray therapy

Megavoltage X-ray therapy

Gamma beam therapy

Radium therapy.

(8) Organ bank.

(9) Blood bank.

(10) Neonatal intensive care.

(11) Health maintenance organizations.

(12) Hemophilia services.

11.0201 Purpose.


The rules in this chapter are set forth for the purpose of interpreting and implementing 13.0106(5) and 13.02 A.S.C.A., the principal provisions of which confer responsibility upon the territorial health planning and development agency for making determinations of need for health facilities and services in the territory.

11.0202 Authority.


The rules codified in this chapter are promulgated under authority of 13.0204 A.S.C.A.

11.0203 Short title.


The rules set out in this chapter shall be known, and may be cited, as “American Samoa Determination of Need Rules and Procedures.”

11.0204 Applicability.


The rules in this chapter shall govern determinations of need in every instance where, under 13.0102(5) A.S.C.A., the territorial health planning and development agency has jurisdiction to determine the need for any health care facility or any part or service of any such facility.

11.0205 Certificate of need required when.


Under the provisions of 13.0205 A.S.C.A., no person or organization, public or private, in the territory of American Samoa may make a substantial change in any health care facility or the services offered therein unless the agency has determined that there is a need for such substantial capital expenditure or substantial change in service and has granted the applicant a certificate of need.

11.0206 Application submits to jurisdiction-Applicability rulings.


(a) Notice is given that any person submitting an application for determination of need to the agency for filing shall be deemed, by virtue of such actions? to submit to the jurisdiction of the agency under this chapter.

(b) Persons desiring a ruling as to the applicability of 13.0205 ASCA to any particular proposed capital expenditure or health service change are advised to request a ruling from the agency before submitting an application.

11.0207 Definitions.


The following words or phrases, as used in this chapter, shall have the following meanings unless the context otherwise requires:

(a) "Action" means the issuance of written findings of need or lack of need for a project described in an application for determination of need, by the review board of the agency.

(b) "Agency" means the territorial (state) health planning and development agency of the ASG.

(c) "Appeals board" means the board appointed by the Governor to consider appeals from the rulings of the agency.

(d) "Applicant" means any person, organization, agency, or institution who applies to the agency for a certificate of need under the act.

(e) "Certificate of need" means a written notification from the agency that the review board has determined that there is a public need for a proposed project as described in an application for certificate of need.

(f) "Construction " means the erection, building, alteration, reconstruction, improvements, renovation, extension, or modification of a health care facility, including its equipment, and the studies, designs, plans, working drawings, and specifications pertaining thereto, and any arrangements or commitments for financing such construction.

(g) "Council " means the American Samoa health coordinating council of PL 16-26.

(h) "Determination of need " means a determination by the review board that the proposed health-care facilities project or health-care services change proposed by an applicant for a certificate of need is needed in the territory to further the purposes stated in 13.0101 ASCA, utilizing the criteria adopted under 13.0209.1 ASCA.

(i) "Health care facility and health care service" means any program, institution, place, building, or agency, or portion thereof, including health maintenance organizations, private or public, used, operated, or designed to provide medical diagnosis, treatment, nursing, rehabilitative, or preventive care to any person or persons, whether preadmission, outpatient, inpatient or postdischarge care, including but not limited to nursing service, home care nursing, and other paramedical service; ambulance service; mental health and psychiatric service; service provided by an intern, reidentin-training, or physician; laboratory service; medical social service; drugs; biologicals; supplies; appliances; and equipment.

(j) "Review board" means the board established by the act for the purpose of reviewing applications for certificate of need under the requirements of 13.0205 ASCA and this chapter.

(k) "Staff' means professional personnel of the territorial health planning and development agency.

(l) "Substantial capital expenditure" means the expenditure of a sum of money for a health care facility or its equipment or predevelopment activities which exceeds, or may reasonably be regarded as leading to, an aggregate expenditure for construction in excess of $100,000, or of $50,000 for equipment only for an undertaking sufficiently specific to constitute the subject matter of an application for determination of need under the act.

(m) "Substantial change in services" means an increase, decrease, or modification in the scope or type, rather than degree, of health services provided, including the addition of a service not previously provided within the 12-month period prior to the provision of the service; specifically, the increase or change in the class of usage of the bed complement of a health care facility, or the relocation from one facility to another, which involves 5 or more beds or 5% or more of the total bed complement, whichever is less.

(n) "The act" means PL 16-26 (Chapters 13.01 and 13.02 ASCA).

11.0208 Time period computation.


Any period of time specified in. this chapter or otherwise in connection with the determination of need program shall include every calendar day, whether the offices of the agency are open on that day or not; except, that when the last day of the period falls on a day when the offices are closed, such period shall end instead on the next day on which the agency is open for business.

11.0209 Forms, applications, and procedures.


Any forms or application instruction or procedures prepared in accordance with this chapter shall be available upon request made in person or in writing to the director or assistant director of territorial health planning and development, L.B.J. Tropical Medical Center. Any revised forms or changes in procedures shall be hand delivered by the agency staff to any person whose application is pending and is affected by the change.

11.0210 Communications between applicant and staff or review board.


(a) Prior to the filing of an application, verbal and written communications between a potential applicant and the staff of the agency or members of the review board shall be freely permitted. All applicants are urged to discuss any proposed projects with the agency staff early in the planning stages of the project so that the applicant becomes thoroughly familiar with the goals, objectives, and priorities of the agency's plans and the procedures and criteria utilized in the determination-of-need review process.

(b) During such time as an application for determination of need is before the agency, the applicant may make verbal or written inquiry of the staff concerning the status or progress of an application or for technical assistance in complying with these regulations. Other written communications are permitted to the staff or review board members if a copy of such communication is forwarded to the director of the agency and all review board members, if relevant to the review.

(c) However, during such time as an application is before the agency for determination of need neither the applicant nor any employee or agent of the applicant shall initiate any oral communication with the director of the agency or any member of the review board to urge a particular outcome concerning such application except at a meeting where notes are kept for inclusion in the public file on the application.

(d) Notice is given that when an applicant, either directly or through an employee or agent, makes a communication which is prohibited by this chapter or is otherwise clearly improper, the agency may dismiss the application.

11.0211 Public records on applications.


The agency, at its health planning office, shall maintain a file, open to public inspection, which shall contain all records of a public nature concerning every application for a determination of need.

11.0212 Public records designated-Status apprisal and information providing.


(a) Each of the following documents relating to an application for a detem1ination of need shall be treated as a public record:

(1) A notice of intent;

(2) An application for detem1ination of need;

(3) Any amendment to an application;

(4) Comments and recommendations of the review board or the applicant;

(5) Agency staff reports;

(6) Findings and action taken;

(7) Requests for appeal;

(8) Appeals board actions;

(9) Public comments; and

(10) Any other written communication of an official nature received by the agency in connection with an application.

(b) The status of any agency review and the infom1ation described in subsection (1) shall be provided to any person subject to the provisions of the act and the public in general, upon request.

11.0213 Enforcing agency apprisal.


The agency shall inform all agencies of government mentioned under 13.0206 ASCA (including the department of manpower resources) of their respective responsibilities in the enforcement of provisions of the act and this chapter.

11.0214 Annual reports.


The agency shall compile a report annually which shall describe any reviews being conducted and their status and shall list all reviews completed since the last published report and a general statement of the findings and decisions made in the course of these reviews. These reports shall be published and notification of their availability published in a local newspaper of general circulation.

11.0215 ASHPDA-Duties.


The health planning and development agency has been specified as the agency to administer the territorial certificate of need program of PL 16-26 and shall assure that all applications for certificate of need are reviewed by its review board in an unbiased manner according to procedures and criteria contained in the act and this chapter.

11.0216 ASHPDA-Location-Address-Telephone number.


(a) The agency is located in the administrative wing of the L.B.J. Tropical Medical Center in Faga'alu.

(b) The address of the agency is State Health Planning and Development Agency, L.B.J. Tropical Medical Center, Pago Pago, American Samoa,96799.

(c) The agency telephone number is 633-4559.

11.0217 Review board-Composition-Chairman-Terms.


(a) The review board members shall be appointed for a tem1 of 3 years and shall include, but need not be limited to:

(1) the director of health planning and development (executive director of the council);

(2) the chairman of the council;

(3) the chairman of the senate committee on public health;

(4) the chairman of the house committee on medical services and public health; and

(5) three other members of the council to be selected by the Governor. In making such selection the Governor may consider the recommendations of the agency.

(b) No more than 3 members of the review board, including the director of health planning and development, may be employees of the department of health.

(c) The director of health planning and development shall chair the review board.

(d) The members of the review board other than those specified in subsection (b) shall serve 3-year terms but may be reappointed for additional terms at the discretion of the Governor. In the event that the chairman of either of the legislative committees mentioned in subsection (a) of this section or the chairman of the council is replaced in those positions by another appointed or elected official, they will continue to serve as members of the review board until any reviews of applications under consideration have been completed. Before the beginning of any new application reviews any such members shall be replaced on the review board by the new incumbents of those positions.

11.0218 Review board-Function-Procedure generally.


(a) The review board is the body of the agency authorized to perform the determination of need function of 13.0205 ASCA.

(b) The function of the review board shall be to review applications for certificate of need. In reviewing such applications, the review board shall follow such procedures as are prescribed under 11.0250 of this code.

(c) Following the review of each application the review board shall make a determination of the need or lack of need for the proposed project and shall accordingly recommend approval, approval with conditions, or disapproval of each such application. In making such determination the review board shall consider criteria contained in 13.0205 ASCA and adopted under 13.0209.1 ASCA, as appropriate, and any other criteria established by this chapter or amendments thereto, and also the staff analysis report of the agency, and any comments of the public in relation to the application.

(d) The review board shall forward its findings to the director of health for official action within 30 days of the completion of its review.

11.0219 Staff activity restrictions.


The following conflict-of-interest provisions shall prevail concerning the conduct of review by the review board: (a) No staff member of the agency may develop any proposal to be reviewed under the review process described in this chapter nor act as representative of, nor on behalf of, the department of health in the submission or presentation of any application for certificate of need to be reviewed under this review process, nor in any other way abuse his special relationship with the review board concerning any application Under review. (b) Staff may, however, voice their own opinions concerning an application in the presentation of any staff analysis during review of any application and may volunteer special information about such reviews which may assist the review board in reaching its own decision, and may provide technical assistance to the department of health to assist in the development of applications for federal projects.

11.0220 Notices of intent-Required-When filed.


Any person or organization intending to initiate a health facilities construction project or substantial change in institutional health services shall file a notice of intent with the agency at the office of territorial health planning and development no less than 14 days prior to the submission of an application for determination of need. Potential applicants are urged to file such notices of intent early in the planning stages of any proposed projects so as to take fullest opportunity of the information and plans of the agency in developing such projects.

11.0221 Notice of intent-Title-Content.


(a) Every notice of intent filed under 11.0220 shall be entitled "Notice of Intent for Health Facilities or Services Project" and shall contain at least the following information:

(1) Name and address of person or organization giving notice;

(2) Location and brief description of proposed project, including type of facility involved, any change in services contemplated, target population to be served;

(3) Amount, type, and sources of financing to be sought; and

(4) Best estimate of total capital expenditures necessary to complete the project.

(b) Also to be included with the notice of intent are any requests for agency ruling as to the necessity for an application for determination of need, requests for technical assistance in preparing application for determination of need, or request for preapplication conference.

(c) A notice of intent form shall be available from the agency upon request, but need not be used; provided, that the requirements of this section are met.

11.0222 Notice of intent-Acknowledgment-Providing forms and information-Response to requests.


Upon receipt of a notice of intent which meets the requirements of 11.0221, the agency shall, within 14 days, acknowledge receipt of such notice and its acceptability, in writing, to the person filing such notice and shall provide such forms and other information as is necessary to complete application at that time. In addition, the agency shall make timely and appropriate response to any other requests mentioned in 11.0221.

11.0223 Technical assistance.


The agency shall provide technical assistance to applicants for determination of need upon request, within the limitations of agency capabilities and resources. Such technical assistance shall be in the nature of:

(1) interpretation of determination of need procedures and criteria;

(2) application instructions;

(3) assistance in filing applications;

(4) interpretation of agency plans, information, or sources of data, or provision of certain data; and (5) any other assistance which the agency considers to be proper and necessary to the filing of an acceptable application.

11.0224 Preapplication conferences.


The agency, at the request of an applicant for determination of need or upon its own initiative, may meet with an applicant to discuss an intended project and its relationship to the goals, objectives, and priorities established by the territorial health plan and annual implementation plans in effect at that time, or findings as to the need for new institutional health services, appropriateness of existing health services, and need for health facilities construction or alterations in the territory.

11.0225 Application-Required-Number of copies.


Every person, organization or government agency seeking a determination of need shall submit an application therefor, in an original and 3 copies, to the territorial health planning and development agency.

11.0226 Application-Standard and emergency.


An application shall be one of the following two types: standard review application or emergency review application. If during the course of any emergency review, the agency determines that the true nature of the project requires a standard review, the applicant shall be so notified and an application for standard review will be required of the applicant.

11.0227 Application-Emergency review justification.


The agency may accept an application for emergency review if it determines that an emergency situation exists requiring the project to prevent the occurrence of damage to, or further damage to, the public health or a health care facility.

11.0228 Application-Form-Content.


The agency shall develop and make available upon request, forms and applications, and abbreviated forms for emergency review applications. The forms shall include such instructions as are necessary to inform applicants of the information required to complete an acceptable application for determination of need. The information required may vary with the type of project. The agency shall inform the applicant of the information to be supplied with the application upon receipt of the notice of intent to apply. In general the information required in any application shall be sufficient in scope and depth to enable a determination of the degree of compatibility with the review criteria designated for reviewing such application. Every application shall contain: a statement signed by the applicant that to the best of the applicant's knowledge the description of the project and the accompanying supportive information is an accurate representation of the true scope and nature of the project.

11.0229 Application-Evaluation-Requirement restrictions.


Upon receipt of an application for determination of need, the agency staff shall evaluate the application for acceptability according to the information requirements prescribed and published for such application. The applicant shall be notified within 14 days of any deficiencies in the application. The agency may require no information which has not been prescribed and published.

11.0230 Application-Justification responsibility -Supporting evidence.


Every applicant shall be given notice that the responsibility for justifying the need for the proposed project lies with the applicant, not the agency staff or the review board. The applicant should submit with his application whatever additional evidence he wishes to place before the review board in support of his application.

11.0231 Application-Emergency form.


Instead of using the application forms referred to in 11.0228, any person or organization may, in an emergency situation described in 11.0227, make application for a determination of need by filing with the agency a letter stating the identity of the applicant, the nature of the emergency, and the nature, scope, location, and estimated cost of the project. Within the discretion of the agency, the applicant may subsequently be required to submit any or all of the usual application forms.

11.0232 Application-Amendment or addition.


Any applicant may amend or submit additional supportive information for any application if submitted to the agency within 14 days after filing the application. If such amendment or additional information constitutes an increase in the maximum estimated capital expenditures for the project or substantially changes the nature, scope, or location of the project, the application must also be amended to reflect these changes.

11.0233 Application-Withdrawal.


Any applicant for determination of need may, at any time, by written notice to the agency, withdraw an application filed under this chapter.

11.0234 Public comment, notice, and document access.


The agency shall afford a reasonable opportunity for public comment on any standard review application for determination of need and shall consider any such comments received, before it acts on any such application. Reasonable opportunity for comment may include a public hearing and shall at a minimum include a public notice, in one or more local newspapers, of the beginning of the review of any application and the accessibility of the application to the public at the territorial health planning and development office for viewing or copying.

11.0235 Notice of beginning of review.


Written notification of the beginning of a review shall be hand delivered to the applicant. Such written notification and public notice of the beginning of a review shall include, at a minimum:

(1) notification of the proposed schedule for the review;

(2) notification of the period within which a public hearing during the course of the review may be requested; and

(3) notification of the manner in which notification will be provided of the time and place of any hearing so requested.

11.0236 Public hearings-When ordered-Request deadline.


The agency shall order a public hearing on an application upon written request of the applicant or any bona fide resident of American Samoa or whenever, in its opinion, a public hearing would aid the staff or review board in carrying out their duties; provided, that such request for public hearing is filed with the agency within 20 days after the notification of beginning of the review. The imposition of any fee for public hearings is prohibited.

11.0237 Public hearings-For reconsideration of agency finding.


(a) Any person may, for good cause shown, request, in writing, a public hearing for purposes of reconsideration of a finding of the agency. Such requests must be received by the agency within 30 days of publication of the notice of the finding of the agency.

(b) Good cause shall be deemed to have been shown by evidence which:

(1) presents significant, relevant information not previously considered by the agency;

(2) demonstrates that there have been significant changes in factors or circumstances relied upon by the agency in reaching its decision;

(3) demonstrates that the agency has materially failed to follow its adopted procedures in reaching its decision; or

(4) provides such other basis for a public hearing as the agency determines constitute good cause.

(c) The findings of the agency after consideration of all comments at his hearing shall be the final decision of the agency, subject to provisions of 13.0211 ASCA.

11.0238 Public hearings-Notice.


The agency shall send to the person requesting the hearing, the applicant, and others upon request, written notification of the time, place, and nature of any public hearing to be held under 11.0236 or 11.0237. Such notice shall also be published in at least one weekly newspaper in the territory at least 10 days before any such public hearing.

11.0239 Public hearings-When held-Place.


A public hearing ordered upon request under 11.0236 shall be held not more than 30 days after it is requested. A public hearing ordered by the agency may be held at any time. If feasible, every public hearing shall be held at a location sufficient in size to accommodate all interested persons.

11.0240 Public hearings-Conduct.


A designated representative of the agency shall be responsible for the conduct of any public hearing, including setting the permissible length of presentation, arranging the order of presentations, and serving as presiding officer. An opportunity shall be provided for any person, who so wishes, to present testimony. Requests to speak shall be made to the presiding officer at the beginning of each public hearing, and, if he permits, during the hearing.

11.0241 Public hearings-Summaries-Applicant comments-Reconsideration findings.


(a) The staff of the agency shall summarize the comments given at each public hearing; except, that a summary of the applicant's comments shall. not be required. It shall be the duty of the applicant to file any comments he or she wishes to enter in the record in writing to the agency.

(b) The agency shall provide written findings of any public hearing held under the provisions of 11.0237, including the basis for its decision, within 30 days after the conclusion of the hearing.

11.0242 Staff reports-Required when.


The agency staff shall prepare a written report on every application for determination of need; provided,that such staff report may be dispensed with in the case of emergency applications filed pursuant to 11.0227.

11.0243 Staff reports-Content.


The staff report on each standard application shall contain at least the following :

(1) A description of the project applied for, with a summary of any supporting material filed by the applicant;

(2) A summary of all comments filed in timely and proper manner by the applicant or a member of the public; and

(3) Any additional material or staff analysis which the staff believes would aid the review board in its determination. The fu11 application and comments may be appended in lieu of a summary of same.

11.0244 Staff reports-Filing and distribution -Contents.


(a) The staff report shall be placed in the public file on the application and copy sent to the applicant to the members of the review board at least 14 days before the board meeting to consider such application.

(b) The applicant or any other affected person shall have the right to file written objections or other comments regarding the staff report; provided, that such comments are received by the agency at least 8 days prior to the review board -meeting to consider such application. If the applicant's comments contain information not previously made available to the staff of the agency, the staff may recommend to the review board tabling of the application until there has been adequate time for further staff analysis.

11.0245 Advocacy by applicant.


An applicant for determination of need may seek to convince the review board of the appropriateness of taking favorable action on its application in the following ways:

(1) by submitting material supporting its application under 11.0228, 11.0230, or 11.0232;

(2) by requesting a public hearing under 11.0236 as a means of bringing to the review board's attention any public opinion favorable to approval of its application;

(3) by filing written comments to the agency staff report under 11.0244; or

(4) by making an oral presentation at the review board meeting at which its application is to be considered.

11.0246 Deadline for agency action and documentation-Failure to act.


The agency shall take final action and document such action in writing under 11.0257 through 11.0265 on every application for determination of need within 90 days after notification of the beginning of the review. A failure to take final action within 90 days of notification shall constitute a determination of lack of need for the project.

11.0247 Prerequisites for agency action.


Except in the case of an emergency application, the agency shall not act on an application under 11.0257 through 11.0265 unless :

(1) the application and any amendments thereto have been on file with the agency at least 20 days after public notification of the filing of such application;

(2) any public hearing requested by the applicant or any other bona fide resident of the territory of American Samoa has been held; and

(3) appropriate opportunity to comment on such application has been afforded the public.

11.0248 Review board meetings-Announcement and public nature-Presiding officer.


The review board shall meet upon the call of the chairman. Meetings shall be announced at least 7 days in advance and shall be open to the public and the press. The chairman or his designee shall preside at every meeting of the review board. When a designee of the chairman presides in the chairman's absence, he shall have all the powers and duties of the chairman under this chapter.

11.0249 Review board meetings-Notice and transmittal of material to members.


Notice of any meeting of the review board shall be transmitted to each member of the board at least 7 days prior to each meeting, together with a copy of the staff report on the application to be considered, if any, and any comments on the application or staff report from the applicant or a member of the public, and any other such material as the agency deems relevant.

11.0250 Review procedure.


Any standard review of an application for determination of need by the; review board shall be conducted in accordance with the following procedures:

(a) Staff Presentation. Unless the chairman directs otherwise, consideration shall begin with an oral presentation by the agency staff. (b) Applicant and Public Presentations. The applicant arid/or any member of the public present shall then be entitled to make an oral presentation of not greater than 10 minutes. If the applicant presents any new evidence or supportive material deemed by the chairman to be significantly different than that submitted with the application or any amendment thereto, the application may be dismissed by the review board upon majority vote of the board.

(c) Questioning and Discussion. Upon completion of all presentation, the review board may question the applicant or the staff for further clarification of the content of the application or the staff analysis report. Following the questioning of the applicant and the agency staff, the applicant may be excused from the meeting prior to discussion of the merits of the project.

(d) Findings and Action. Concluding such discussion and consideration of the application, the review board shall make such finding and take such action as it deems appropriate, by motion duly made and seconded and voted, and shall prepare a statement of such action and the reasons therefor. Such statement, when signed by the chairman, shall constitute official record of the action of the agency concerning the review for determination of need or lack of need for the project described in the application.

11.0251 Official record of review board action.


Following every meeting at which the review board acts upon an application, the chairman shall cause such action, and the reasons therefor in the case of final action, to be reduced to a written statement. The chairman may, within his discretion, consult with members of the review board voting for an action in order to confirm that such statement is in accordance with their views, or may place such statement before the review board for ratification. Such statement, when signed by the chairman, shall constitute official record of any action taken at the review board meeting and shall be included in or appended to the minutes of such meeting.

11.0252 Preliminary action-Permitted-Procedure.


The review board, upon consideration of an application on its agenda, may, when it considers final action inappropriate, by motion duly made, seconded, and voted, take preliminary action thereon.

11.0253 Preliminary action-Alternatives.


As preliminary action upon an application, the review board may:

(1) notify the applicant and all other participants in the proceeding of its intent to resume consideration of the application at a subsequent meeting;

(2) direct the staff to conduct further review of the application in the manner directed, and to report in writing to the review board within a specified period;

(3) request a public hearing with respect to the application on such subjects and within such period as the review board may specify;

(4) request additional supporting documentation from the applicant, to be submitted on such subjects and within such period as the review board may specify;

(5) consult with the applicant concerning his willingness to submit an amendment to his application; or

(6) take such other action as, in the opinion of the review board, will facilitate final action on the application.

11.0254 Dismissa1-Permitted.


The review board, upon consideration of an application on its agenda, may, by motion duly made, seconded, and voted, dismiss such application without making a determination of need or lack of need.

11.0255 Dismissal-Grounds.


No application shall be dismissed except on one of the following grounds :

(1) The applicant has failed to file a notice of intent to apply;

(2) The applicant has made an improper communication to any review board member or staff member, as under 11.0210, or has sought to exert undue influence on any such person or upon any person testifying at a public hearing to comment on an application for determination of need;

(3) The applicant has made a false statement or misrepresented a material fact in any oral or written communication to the review board in connection with his application; or ( 4) The applicant has otherwise failed substantially or repeatedly to comply with the provisions of these regulations.

11.0256 Dismissal-Procedures.


The review board may dismiss such application with or without prejudice to submission of a new application, as it deems appropriate. Every dismissal shall be reduced to writing and shall set forth the reasons therefor.

11.0257 Final determination deadline.


Within 90 days of the filing of a standard review application for determination of need unless such application is not acceptable under the requirements of 11.0228 through 11.0231, or is sooner dismissed (see 11.0254,11.0255, and 11.0256), the review board shall, by motion duly made, seconded, and voted, make a final determination of need or lack of need.

11.0258 Objective in determination.


In making determinations of need, the review board shall have as its objective the appropriate allocation of ASG and federal health care resources and the development of improved systems of delivering health care services so that adequate health care services will be reasonably accessible to every person in the territory at the lowest reasonable aggregate cost. No project described in any application shall be determined to be needed w4ich is not consistent with this objective.

11.0259 Findings required.


(a) In taking final action under this chapter, the review board shall not make a determination of need on any application for proposed new institutional health services or facilities for inpatients unless it first makes each of the following findings in writing (such findings shall include the basis for the findings and shall be sent by mail to the applicant and made available to the public upon request) :

(1) That less costly, more efficient, or more appropriate alternatives to such proposed in-patient services are not available and the development of such alternatives has been studied and found not practicable;

(2) That, in the case of new construction, alternatives to new construction; e.g., modernization or sharing arrangements, have been considered and have been implemented to the maximum extent practicable;

(3) That patients will experience serious problems, in terms of cost, availability, or accessibility or other such problems as may be identified by the agency, in obtaining inpatient services of the type proposed in the absence of the proposed new services.

(b) The review board must also make the following written findings before a determination of need for such proposed inpatient services may be made:

(1) The efficiency and appropriateness of the use of existing inpatient facilities providing in-patient services similar to those proposed; and

(2) The capital and operating costs (and the potential impact on patient charges), efficiency, and appropriateness of the proposed new in-patient service.

11.0260 Determination criteria-Consideration.


(a) In addition to the mandatory findings required by 11.0259, the review board shall consider such of the criteria set forth in 11.0261, 11.0262, and 11.0263 as it deems relevant to making an appropriate determination of need on a particular application.

(b) A finding adverse to an applicant regarding any of the criteria under 11.0261, 11.0262, and 11.0263 relevant to a particular application may be sufficient to constitute grounds for a determination of lack of need. An adverse ruling on an individual criterion, however, is not in itself necessarily grounds for a determination of lack of need. The applicant may be able to show that the proposed project merits a determination of need on consideration of all relevant criteria even though it does not meet each individual criteria considered.

11.0261 Determination criteria-Services and equipment.


Criteria for determining need for health care services and equipment :

(1) Targeting to Needs. The proposed service (equipment) is aimed at a specific unmet or inadequately met community health need;

(2) Benefit Potential. The proposed service (equipment) has potential for improving health status or health care delivery;

(3) Plans Conformance. The proposed service conforms to the goals, objectives, priorities, and recommendations of the territorial health plan and the annual implementation plan of the agency, and supports other overall or long-range plans of the territory (including the Territorial Medical Facilities Plan and any long-range development plans of the applicant);

(4) Alternatives. The availability of less costly or more effective alternative means of meeting the need;

(5) Utilization Pattern Effects. Relationships of the proposed service to existing or desired patterns of health services utilization;

(6) Ancillary and Support Services. The relationship of the proposed health services to ancillary or support services;

(7) Implementation Resources. The availability of adequate resources (including facilities, manpower, and finances) to successfully implement the proposed service (utilize the equipment) initially and during the duration of need, and the potential for alternative uses of such resources for the provision of other health services.

(8) Cost Feasibility and Justification. The immediate and long-term costs associated with the proposed service (equipment), including secondary costs of the effect on existing services or facilities, are feasible and justified by the expected benefits and/or utilization of the service (equipment).

(9) Controls. The proposed service includes provisions for monitoring, measuring the impact, or assuring the quality of the service.

(10) Location. The accessibility and appropriateness of the proposed service location.

11.0262 Determination criteria-New facilities for new services.


Criteria for determining need for new health care facilities to house new services :

(1) Service Need.The service to be housed by the facility has been determined to be needed according to 11.0261;

(2) Plan Conformance. Conformance of the proposed facility with the Territorial Medical Facilities Plan;

(3) Alternatives. Availability of alternative facilities;

(4) Location. Appropriateness of the proposed facility location;

(5) Long-term Funding. Ability to fund developmental, operational, and maintenance costs over the projected useful life of the proposed facility;

(6) Utilization Effects. Effect on utilization of existing facilities and patterns of service;

(7) Utilities and Energy Use. Assurance of adequate utility supply and consideration of the costs and method of energy provision and impact on energy consumption;

(8) Costs, Construction Methods, and Cost Impact. The costs and construction methods of the proposed facility and the probable impact of the project on the costs of providing health services by the organization proposing such project;

(9) Adequacy of Resources for Use. The proposed facility can be adequately staffed, equipped, and operated when completed;

(10) Cost Containment and Quality Improvement. The proposed facility will foster cost containment or improved quality of care through improved efficiency and productivity, including promotion of cost-effective factors such as ambulatory care or design and construction economies.

11.0263 Determination criteria-New facilities for existing services.


Criteria for determining need for new facilities to house existing health services:

(1) Other New Facilities Criteria. Criteria set forth in 11.0262; and

(2) Unsuitability to Needs and Alternatives to Construction. Existing physical facility is unsuited for the service needs -feasibility of renovation, alterations, additions, modifications, expansion, etc.; -

(3) Location Unsuitability. Existing facility location is unsuited to services needs.

(4) Standards Compliance. Need to bring existing facility into compliance with certification, licensure, safety, or other code requirements -feasibility of alterations to meet standards, and need to meet standards.

11.0264 Applicant demonstration of need-Determination data resources.


(a) The sole responsibility for demonstrating the need for any proposed project of an application for determination of need shall lie with the applicant.

(b) In making determinations under this chapter, the review board shall rely upon such vital statistics and other demographic data, such resource inventories, and such utilization and other health care studies and plans as it deems appropriate and useful. Any such material relied upon by the review board in making determinations of need shall be kept by the agency and shall be subject to inspection and copying by any person upon request.

11.0265 Issuance of certificate-Director action contrary to board.


(a) The agency director, acting on the findings of the review board, shall issue a certificate of need to each applicant where application has received a positive determination of need by the review board. No certificate of need may be issued unless the review board has determined that there is a need for the project according to the procedures and criteria contained in 11.0205 (1) or adopted under 11.0209.1 ASCA, and this chapter.

(b) The agency director may act contrary to appeal the decision of the review board only if he can show reasonable evidence that the review board has:

(1) overlooked or ignored important evidence before it in reaching its decision;

(2) failed to follow appropriate procedures prescribed in this chapter;

(3) acted without regard for a conflict of interest situation; or

(4) received improper verbal communications during the course of the review.

11.0266 Term of determination-Changes to projects.


Determinations of need and certification thereof shall be valid for 1 year. The review board, for good cause shown and not otherwise, may, in writing, grant an extension of the period of validity. Such determinations of need shall be valid only for the scope of the project for which made and only for the estimated range of capital expenditures approved. Any proposed changes to a project given a determination of need which exceeds 10% of the original estimated project costs shall require review and approval of the review board unless such change order exceeds $100,000, or $50,000 for equipment only, in which case the proposed change shall require a standard review application and a determination of need just as if such proposed change was a new project.

11.0267 Notice of review board action-Effective date.


(a) Whenever the review board takes preliminary or final action upon an application for determination of need, it shall be the responsibility of the chairman to send appropriate notice in writing to the applicant and the council. In the case of final action taken, such notice shall also be published in a territorial newspaper of general distribution.

(b) Such notice shall, in every instance, set forth the final action taken and the reasons therefor, and the rights and duties of each person or agency notified with respect to the action. The chairman shall endeavor to send notice within 7 days of final action, but in no event shall more than 30 days be allowed for such purpose.

(c) Unless otherwise stated therein, a determination shall not take effect until notice thereof is received by the affected applicant.

11.0268 Revocation.


(a) The review board is authorized to revoke a determination of need for failure of an applicant to comply with all terms and conditions of the determination of need established in accordance with 11.0266. If the chairman of the review board has reason to believe that a determination of need should be revoked :

(1) he shall make whatever preliminary inquiry of the holder of the certificate of need he deems appropriate in the situation in order to clarify whether a term or condition has not been complied with and whether such a failure to comply is justifiable;

(2) if no satisfactory explanation is forthcoming, he shall cause the matter to be placed on the agenda of a review board meeting for its consideration;

(3) he shall notify the applicant of his intended action and shall specify the reasons therefor and indicate that the holder will be afforded an opportunity to address the review board concerning its action;

(4) at the relevant meeting, the review board shall afford the holder and other affected persons an opportunity to speak, and is authorized to take such action as it deems fair and appropriate in the situation.

11.0269 Appeals board review-Complaints to board.


(a) Any determination of need or lack of need made pursuant to the act and this chapter is subject to review by the appeals board established by the act in the manner and under the terms set forth in 13.0211 and 13.0212 ASCA.

(b) Any appeal must be made to the appeals board within 30 days of the final determination of the review board. The appeals board shall act on any appeal before it within 30 days of receipt of such appeal. Proceedings before the board are governed by rules of procedure adopted by the board and available at the Governor's office. The agency advises every applicant, the council, and the public that whenever such person, agency, or group is not satisfied with an action of the review board 0( the agency during the pendency of an application, it should make its objection in writing to the chairman of the review board; otherwise, upon appeal, the review board will argue that complaint on such ground has been waived by the complainant's failure to raise its objection with the review board and to allow the review board opportunity to respond thereto. Communication to the review board regarding any such complaint shall be directed to its Chairman, Health Planning and Development Office, LBJ Tropical Medical Center, PagoPago, American Samoa 96799.

(c) The decision of the appeals board must be made in writing and sent to the agency and the applicant, and made available to others upon request, within 60 days of the date of filing of any appeal.

(d) When a decision made by the appeal board is determined to be inconsistent with the goals and priorities of the territorial health plan or annual implementation plan, the appeals board shall submit to the agency and the Governor a detailed statement of the reasons for the inconsistency.

11.0270 Agency review-Appeals board or judicial remedy.


Any applicant for determination of need aggrieved by the action of the review board in denying acceptance of an application or by dismissal of an application, or by a determination of lack of need upon an application, may be afforded an opportunity for administrative review within the agency upon written request filed with the director of health planning and development, LBJ Tropical Medical Center, within 30 days of notification of such action, such dismissal, or such determination. An aggrieved applicant may, at its election, dispense with such review within the agency and seek appeal with the appeals board or whatever judicial remedy may be available.

(a) Upon a timely request for agency review of the action of the review board in refusing to accept or revoking acceptance of an application or an amendment, or of a determination of need or lack of need, the director of health planning and development i authorized to assign an attorney, employed by the agency and not otherwise involved in the determination-of-need program, to review such action for legal error and to report thereon to the agency. Upon consideration of such report, the agency shall reverse or modify the action complained of if it concludes such action was an abuse of the discretion committed to the review board, in violation of lawful procedures, or otherwise not in accordance with applicable provisions of law.

(b) If the final decision of the agency is to reverse the determination, the application shall be reinstated and a new determination shall be made.

11.0271 Rulemaking-Applicability of provisions.


This section through 11.0274 govern the procedure to be used to adopt, amend, or repeal agency rules.

11.0272 Rulemaking-Notice of proposal.


When upon its own initiative the agency proposes to adopt, amend, or repeal a rule, a notice of proposed rulemaking will be published, in a territorial newspaper of general circulation, stating that new/revised procedures and/or criteria have been proposed for adoption and that these proposed procedures are available at the agency offices for inspection and/or copying.

11.0273 Rulemaking-Public hearing.


(a) Requirement. A public hearing will be held for all proposed issuance, amendment, or repeal of rules initiated by the agency.

(b) Presiding Officer and Conduct. Each such hearing will be conducted by the director of health planning and development or an authorized representative. The hearing will be conducted in such a way as to afford interested persons a reasonable opportunity to be heard on matters relevant to the issues involved and to obtain a clear and orderly record. (c) Continuance of Hearing. Each such hearing will be held at the time and place set in the notice of hearing, but may at such time and place be continued from day to day or adjourned to a later date or a different place without notice other than the announcement thereof at the hearing.

(d) Order of Business. At the commencement of the hearing the presiding officer will read the notice of hearing and will then outline briefly the procedure to be followed. Testimony will then be received with respect to the matters specified in the notice of hearing, in such order as the presiding officer prescribes.

(e) Submission of Testimony. All interested persons will be given reasonable opportunity to offer testimony with respect to the matters specified in the notice of hearing. Every witness will, before proceeding to testify, state his name, address, and whom he represents at the hearing. The presiding officer shall confine the testimony to the issue before the hearing.

(f) Oral and Written Presentation. All interested persons or agencies of the territory will be afforded an opportunity to submit data, views, or arguments which are relevant to the issues, orally or in writing. Written testimony should be submitted to the agency at its office 24 hours or more prior to the hearing. Persons submitting written testimony on he day of the hearing must furnish 10 copies of such testimony to the agency staff prior to the hearing. In addition, or in lieu thereof, persons or agencies may also file with the agency, within 7 days following the close of the public hearing, a written protest or other comments or recommendations in support of or in opposition to the proposed rulemaking. The period for filing written protests, comments, or recommendations may be extended by the presiding officer for good cause.

(g) Transcript. Unless otherwise specifically ordered by the presiding officer, testimony given at the hearing will not be reported verbatim. All supporting written statements, maps, charts, tabulations, or similar data offered at the hearing, and which are deemed by the presiding officer to be authentic and relevant, will be received and made a part of the record. Unless the presiding officer finds that the furnishing of the copies is impracticable, 2 copies of the exhibits will be submitted.

11.0274 Rulemaking-Distribution of proposals-Comments.


(a) Copies of the proposed rules will be sent to all territory-wide health agencies and organizations and to the council at the time of notice of public hearing. Comments will be received in writing by the agency for 7 days following the conclusion of the public hearing

(b) Copies of the adopted or revised rules will be distributed to all territory-wide health agencies, the council, the enforcing agencies mentioned in 11.0206 ASCA, the appeals board, the Governor, the Legislature, the Secretary of HHS, and others upon request.

11.0275 Reports-Who must submit.


(a) All providers of health services, and other persons or organizations subject to the provisions of 13.0205

(a) ASCA shall submit to the agency periodic written reports respecting the development of projects or services subject to review.

(b) Such reports shall be submitted at such times, in such form, and contain such information as required by the agency.

11.0276 Reports-Notice of requirement.


The agency will inform all persons or organizations under 11.0275 of the requirement for submission of periodic reports initially, and will send reminders to each 1 month before such reports are due.