These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-17-10, and are established for the purpose of adopting minimum standards for licensed school-based health centers in this state.

A. These regulations hereby adopt and incorporate "Clinical Laboratory Improvement Amendments of 1988." Department of Health and Human Services (1992) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.

B. These regulations hereby adopt and incorporate the School-Based Health Alliance, Core Competencies, June 2017, by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.

A. Wherever used in these rules and regulations, the following terms shall be construed as follows:

1. "Department" means the Rhode Island Department of Health.

2. "Director" means the Director of the Rhode Island state Department of Health.

3. "Health care facility" means any institutional health service provider, facility or institution, place, building, agency, or portion thereof, whether a partnership or corporation, whether public or private, whether organized for profit or not, used, operated, or engaged in providing health care services, including but not limited to hospitals; nursing facilities; home nursing care provider (which shall include skilled nursing services and may also include activities allowed as a home care provider or as a nursing service agency); home care provider (which may include services such as personal care or homemaker services); rehabilitation centers; kidney disease treatment centers; health maintenance organizations; free-standing emergency care facilities, and facilities providing surgical treatment to patients not requiring hospitalization (surgi-centers); hospice care, and physician office settings providing surgical treatment. The term "health care facility" also includes organized ambulatory care facilities which are not part of a hospital but which are organized and operated to provide health care services to outpatients such as central services facilities serving more than one health care facility or health care provider, treatment centers, diagnostic centers, rehabilitation centers, outpatient clinics, infirmaries and health centers, school based health centers, and neighborhood health centers; providing, however, that the term "health care facility" shall not apply to organized ambulatory care facilities owned and operated by professional service corporations as defined in R.I. Gen. Laws Chapter 7-5.1 (the "Professional Service Corporation Law"), or to a private practitioner's (physician, dentist, or other health care provider) office or group of the practitioners' offices (whether owned and/or operated by an individual practitioner, alone or as a member of a partnership, professional service corporation, organization, or association). Individual categories of health care facilities shall be defined in rules and regulations promulgated by the Department with the advice of the Health Services Council. Rules and regulations concerning hospice care shall be promulgated with regard to the "Standards of a Hospice Program of Care", promulgated by national hospice organization. Any provider of hospice care who provides such hospice care without charge shall be exempt from the licensing provisions of R.I. Gen. Laws Chapter 23-17, but shall meet the "Standards of a Hospice Program of Care." Facilities licensed by the Department of Behavioral Health, Developmental Disabilities, and Hospitals, and the Department of Human Services, and clinical laboratories licensed in accordance with R.I. Gen. Laws Chapter 23-16.2 as well as Christian Science institutions (also known as Christian Science Nursing Facilities) listed and certified by the Commission for Accreditation of Christian Science Nursing Organizations/Facilities, Inc. shall not be considered health care facilities for purposes of R.I. Gen. Laws Chapter 23-17.

4. "Limited function test" means those tests listed in the Federal Register under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as waived tests.

5. "Person" means any individual, trust or estate, partnership, corporation (including associations, joint stock companies) state, or political subdivisions or instrumentally of the state.

6. "Premises" means a tract of land and the buildings thereon where direct patient care services are provided.

7. "School-based health center" means a facility located in an elementary or secondary school that delivers primary and preventive health care services to students on-site.

18.4.1 General Requirements

A. No person acting severally or jointly with any other person shall establish, conduct, or maintain a school-based health center in this state without a license in accordance with the requirements of R.I. Gen. Laws § 23-17-4, and shall meet the requirements of this Part. In order to apply for and/or to maintain a school-based health center license, a person must possess a current license as a health care facility under the provisions of R.I. Gen. Laws Chapter 23-17.

B. No person shall represent itself as a school-based health center unless licensed as a school-based health center pursuant to the provisions of this Part.

C. School health services provided to students in accordance with this Part shall not require licensure as a school-based health center. Nothing in these regulations shall be construed as prohibiting school health personnel from rendering school health services in accordance with this Part.

D. School-based health centers shall be exempt from the provisions of R.I. Gen. Laws §§ 23-17-14.3 and 23-17-14.4.

18.4.2 Application for License

A. Application for a license to conduct, maintain or operate a school-based health center shall be made to the Department upon forms provided by it, and shall contain such information as the Department reasonably requires, including but not limited to, evidence of ability to comply with the provisions of R.I. Gen. Laws Chapter 23-17 and this Part.

B. A notarized listing of names and addresses of direct and indirect owners of the licensed health care facility (see requirements of § 18.4.1(A) of this Part) whether individual, partnership, or corporation with percentages of ownership designated shall be provided with the application for licensure and shall be updated annually. The list shall include each owner (in whole or in part) of the facility or any of the property or assets of the facility. The list shall also include all officers, directors and other persons or any subsidiary corporation owning stock, if the facility is organized as a corporation, and all partners if the facility is organized as a partnership.

C. There shall be a current, written memorandum of understanding in place that delineates the responsibilities of both the facility and the public school district.

18.4.3 Issuance and Renewal of License

A. Upon receipt of an application for a license, the Department shall issue a license or renewal thereof for a period of no more than one (1) year if the applicant meets the requirements of R.I. Gen. Laws Chapter 23-17. Said license, unless sooner suspended or revoked, shall expire by limitation on the 31st day of December following its issuance and may be renewed from year to year after inspection and approval.

B. A license shall be issued to a specific licensee for a specific location and shall not be transferable. The license shall be issued only for the premises and the individual owner, operator, or lessee or to the corporate entity responsible for its governance.

C. Thirty (30) days prior to voluntary cessation of any school-based health center license, the Department shall be notified and provided with a plan for orderly closure, notification and transfer of patients, transfer and storage of medical records, and notification of the public.

18.4.4 Inspections

A. The Department shall make or cause to be made such inspections and investigations as it deems necessary, including health care records, in accordance with R.I. Gen. Laws § 23-17-10 and this Part.

B. Every school-based health center shall be given prompt notice by the Department of any deficiencies reported as a result of an inspection or investigation.

18.4.5 Denial, Suspension, Revocation of License or Curtailment of Activities

A. The Department is authorized to deny, suspend or revoke the license of or to curtail the activities of any school-based health center which:

1. Has failed to comply with the rules and regulations pertaining to the licensing of a school-based health center; and

2. Has failed to comply with the provisions of R.I. Gen. Laws Chapter 23-17.

3. Reports of deficiencies noted in inspections conducted in accordance with § 18.8.2 of this Part shall be maintained on file in the Department, and shall be considered by the Department in rendering determinations to deny, suspend or revoke the license or to curtail activities of a school-based health center.

B. Whenever an action shall be proposed to deny, suspend or revoke the license of or to curtail the activities of a school-based health center, the Department shall notify the school-based health center by certified mail, setting forth reasons for the proposed action, and the applicant or licensee shall be given an opportunity for a prompt and fair hearing in accordance with R.I. Gen. Laws §§ 23-17-8 and 42-35-9 and pursuant to the provisions of § 18.8.3 of this Part.

1. However, if the Department finds that public health, safety or welfare imperatively requires emergency action and incorporates a finding to that effect in its order, the Department may order summary suspension of license or curtailment of activities pending proceedings for revocation or other action in accordance with R.I. Gen. Laws §§ 23-1-21 and 42-35-14(c).

C. The appropriate state agencies shall be notified of any action taken by the Department pertaining to either denial, suspension, or revocation of license or curtailment of activities.

18.5.1 Governing Body and Management

A. Each facility shall have an organized governing body or equivalent legal authority, ultimately responsible for:

1. The program and operation of the school-based health center;

2. The assurance of the quality of care and services; and

3. The compliance with all federal, state and local laws and regulations pertaining to safety, sanitation, communicable and reportable diseases, smoking policies and other health and safety requirements relevant to school-based health centers and all rules and regulations of this Part.

B. The governing body or equivalent legal authority shall ensure appropriate personnel, physical resources, and equipment to facilitate the delivery of school-based health center services, during established hours of operation.

C. The governing body or equivalent legal authority shall adopt written policies defining the responsibilities for the operation and performance of the school-based health center and identifying purposes and means of fulfilling such. In addition, the governing body or equivalent legal authority shall establish administrative/clinical policies pertaining to no less than the following:

1. The scope of health and medical services to be provided, as described in the School-based Health Alliance, Core Competencies, June 2017, incorporated by reference at § 18.2(B) of this Part;

2. Maintain linkages and referrals with other health care facilities to assure continuity of care;

3. Quality assurance for patient care and services; and

4. Such other matters as may be relevant to the organization and operation of the school-based health center.

18.5.2 Quality Improvement

A. The governing body shall ensure that there is an effective, ongoing, school-based health center wide quality improvement program to evaluate the provision of patient care. The quality improvement activities at the school-based health center shall be coordinated with and integrated into the quality improvement activities for similar services at other health care facilities operated by the licensee.

B. The organized school-based health center wide quality improvement program shall be ongoing and shall have a written plan of implementation.

C. The school-based health center shall take and document appropriate remedial action to address problems identified through the quality improvement program. The outcome(s) of the remedial action shall be documented.

18.5.3 Pending and Actual Labor Disputes/Actions

Health care facilities shall provide the Department with prompt notice of pending and actual labor disputes/actions pursuant to R.I. Gen. Laws § 23-17-48.

18.5.4 Medical Oversight

Each school-based health center shall have a physician licensed in this state who shall be responsible for the achievement and maintenance of the quality of health care services and the establishment of policies and procedures for health care services based on recognized standards of practice.

18.5.5 Personnel

A. The school-based health center shall be staffed with appropriate professional and ancillary personnel who shall be assigned duties and responsibilities that are consistent with licensure/certification requirements, their training and experience, and services rendered. Staff performing functions requiring certification and/or licensure shall be duly licensed in Rhode Island as required by statute.

B. Each school-based health center shall have at least one (1) appropriately qualified health professional staff person on duty at all times when services are provided.

C. A health care facility shall require all persons who examine, observe, or treat a patient of such facility to wear a photo identification badge which includes the information required by R.I. Gen. Laws § 23-17-47. This badge shall be worn in a manner that makes the badge easily seen and read by the patient or visitor.

D. The school-based health center shall have written job descriptions that define qualifications, responsibilities, and supervision of all school-based health center personnel.

18.5.6 Health Screening

Upon hire and prior to delivering services, a pre-employment health screening shall be required for each individual who has or may have direct contact with a patient of the school-based health center. Such health screening shall be conducted in accordance with the rules and regulations pertaining to Immunization, Testing, and Health Screening for Health Care Workers (Part 20-15-7 of this Title).

18.5.7 Rights of Patients

A. Consistent with R.I. Gen. Laws § 23-17-19.1(16), each school-based health center shall observe each of the following age-appropriate rights with respect to each patient who utilizes the facility.

B. Each patient can expect to:

1. Be treated respectfully.

2. Receive the information needed to make intelligent choices about the health care received.

3. Receive information concerning treatment and be informed of the medical consequences of refusing treatment.

4. Receive private, confidential care.

5. Have the ability to refuse the release of medical records.

6. Receive referrals for care that the provider is unable to meet.

7. Have the ability to register complaints regarding the care received or lack thereof.

8. Have school-based health center respond in a reasonable manner to the request of a patient’s physician for medical services to the patient. The school-based health center shall also respond in a reasonable manner to the patient’s request for other services customarily rendered by the school-based health center to the extent the services do not require the approval of the patient’s physician or are not inconsistent with the patient’s treatment;

9. Be furnished with the identities of all other health care and educational institutions that the school-based health center has authorized to participate in the patient’s treatment and the nature of the relationship between the institutions and the school-based health center;

10. Upon request, be informed of any research project, and be offered the right to refuse to participate in the project. The school-based health center shall also comply with any additional provisions for research stipulated by the school department.

11. Have the ability to examine any pertinent school-based health center rules and regulations that specifically govern the patient’s treatment;

12. Be offered treatment without discrimination as to race, color, religion, national origin, sexual orientation, disability, or source of payment.

C. Each school-based health center shall display in a conspicuous place in the licensed school-based health center a copy of the "Rights of Patients”, including but not limited to, the patient rights stated above.

18.6.1 Management of Services

A. Policies and procedures pertaining to the provision of services and supported by appropriate manuals and reference material shall be established by the appropriate professional staff and approved by the governing body. Such policies and procedures shall pertain to no less than the following:

1. The responsibility of the physician(s) for the provision of health care services;

2. The designation of personnel authorized to deliver health care services in accordance with licensure and/or certification requirements;

3. Standards of practice for each health care service provided;

4. Procedures that may and may not be performed;

5. Procurement and storage of all drugs and medications in accordance with R.I. Gen Laws Chapters 21-28 and 21-31 and disposal of all drugs and medications in accordance with the rules and regulations for Disposal of Drugs (Part 20-20-1 of this Title);

6. Designation of personnel authorized to prescribe, administer, dispense, or dispose of drugs in accordance with licensure and/or certification requirements;

7. Disposal of hypodermic needles, syringes and instruments in accordance with the requirements of the rules and regulations for Hypodermic Needles, Syringes, and Other Such Instruments (Part 20-15-6 of this Title);

8. Disclosure of patient information in accordance with federal and state law; and

9. Such other conditions as may be deemed appropriate.

18.6.2 Laboratory Services

A. Clinical laboratory services may be provided on the premises of the school-based health center.

1. If the laboratory services only consist of limited function tests, as defined by this Part, these services shall be subject to the “Clinical Laboratory Improvement Amendments of 1988” incorporated above at § 18.2(A) of this Part.

2. If the laboratory services consist of tests more complex than limited function tests, the laboratory shall be additionally subject to the provisions of R.I. Gen. Laws Chapters 23-16.2 and 23-16.3, and the regulations adopted thereunder.

18.6.3 Infection Control

A. Policies and procedures governing infection control and reporting techniques shall be established in accordance with this section.

B. Infection control provisions shall be established for the mutual protection of patients, employees, and the public.

C. Reporting of Communicable Diseases:

1. School-based health center personnel who are charged with reporting communicable diseases (e.g., physicians, physician assistants, registered nurse practitioners, midwives) shall promptly report to the Department cases of communicable diseases designated as "reportable diseases" by the Director of Health, when such cases are diagnosed in the school-based health center in accordance with the rules and regulations pertaining to Reporting and Testing of Infectious, Environmental and Occupational Diseases (Part 30-05-1 of this Title).

2. When infectious diseases present a potential hazard to patients or personnel, these shall be reported to the Department, even if not designated as "reportable diseases."

3. School-based health centers must, in addition, comply with all other laboratory reporting requirements for tuberculosis, HIV/AIDS, sexually transmitted diseases, childhood lead poisoning, and occupational diseases as outlined in the regulations of Reporting and Testing of Infectious, Environmental and Occupational Diseases (Part 30-05-1 of this Title).

18.6.4 Health Care Records

A. Each school-based health center shall maintain a health care record on every patient seeking health care services.

B. For each visit to the school-based health center, the health care record shall contain documentation relating to the following:

1. Patient identification (name, address, age and sex);

2. Pertinent health history and physical findings;

3. Diagnostic and therapeutic orders;

4. Reports of procedures, tests and findings of each visit;

5. Diagnostic impressions; and

6. Such other pertinent data as may be necessary to insure continuity of patient care.

C. Procedures shall be established to ensure confidentiality of all medical records, including computer or electronic records.

D. Each school-based health center shall make provisions for the appropriate release or transfer of patient care information in accordance with the legal requirements governing confidentiality of health care information.

E. All medical records, either originals or accurate reproductions, shall be preserved for a minimum of five (5) years, except that records of minors shall be kept for at least five (5) years after such minor shall have reached the age of 18 years.

18.6.5 Medical Equipment

Medical equipment and supplies for the reception, appraisal, examination, treatment and observation of patients shall be determined by the amount, type and extensiveness of services provided.

18.7.1 Physical Facility

A. All construction shall be subject to the laws, rules, regulations and codes of R.I. Gen. Laws Chapters 23-17, 23-28.1, 23-27.3 and all other appropriate state and local laws, codes, regulations and ordinances. Where there is a difference between codes, the code having the more stringent standard shall apply.

B. Any plans for alterations, extensions, modification, renovation or conversion of an existing facility shall be submitted to the Department for review and approval prior to construction.

C. Provisions shall be made for all of the areas listed below, some of which may be multipurpose in order to provide the following:

1. At least one (1) examining room with provisions that each examining room include hand-washing facilities that include a sink and running water, and that each examining room is private such that conversations cannot be overheard;

2. A counseling room that is private such that conversations cannot be overheard;

3. A bathroom with hand-washing facilities;

4. Office and administrative space where staff can work privately with records;

5. Secure areas for the protection of medical records, pharmaceuticals, and supplies;

6. Waiting room area.

D. The school-based health center building shall also conform with the following provisions:

1. Fire protection standards that meet local codes;

2. Water and waste disposal systems conforming with local codes, Narragansett Bay Commission and Federal OSHA requirements;

3. Separate telephone lines and an answering machine telling students how to obtain emergency services after hours;

4. Adequate lighting;

5. Proper ventilation;

6. Provisions for clients with special needs, as appropriate.

18.7.2 Environmental Maintenance

A. The school-based health center shall be maintained and equipped to provide a sanitary, safe and comfortable environment with all furnishings in good repair, and the premises shall be kept free of hazards.

B. Appropriate equipment and supplies to clean the school-based health center shall be maintained in a safe, sanitary condition.

C. Hazardous cleaning solutions, compounds and substances shall be labeled, stored in a safe place and kept in an enclosed section separate from other cleaning materials.

18.7.3 Waste Disposal

A. Medical Waste

1. Medical waste, as defined in the Medical Waste Regulations, 250-RICR-140-15-1, shall be managed in accordance with the provisions of the aforementioned regulations.

B. Other Waste:

1. Wastes which are not classified as medical waste, hazardous wastes or which are not otherwise regulated by law or rule may be disposed in dumpsters or load packers.

18.7.4 Disaster Preparedness

A. Each school-based health center shall develop and maintain a written disaster preparedness plan that shall include plans and procedures to be followed in case of fire and/or other emergencies. This disaster preparedness plan shall be coordinated with the school's plan for fire and/or other emergencies.

B. Emergency steps of action shall be clearly outlined and posted in conspicuous locations throughout the school-based health center.

C. Simulated drills testing the effectiveness of the plan shall be conducted for all personnel at least twice a year. Written reports and evaluation of all drills shall be maintained by the school-based health center.

18.7.5 Fire Safety

Each school-based health center shall meet the requirements of R.I. Gen. Laws Chapter 23-28.1 pertaining to fire and safety.

18.8.1 Variance Procedures

A. The Department may grant a variance either upon its own motion or upon request of the applicant from the provisions of any rule or regulation in a specific case if it finds that a literal enforcement of such provision will result in unnecessary hardship to the applicant and that such a variance will not be contrary to the public interest, public health and/or health and safety of patients.

B. A request for a variance shall be filed by an applicant in writing, setting forth in detail the basis upon which the request is made.

1. Upon the filing of each request for variance with the Department, and within a reasonable time thereafter, the Department shall notify the applicant by certified mail of its approval or in the case of a denial, a hearing date, time and place may be scheduled if the facility appeals the denial and in accordance with the provisions of § 18.8.3 of this Part.

18.8.2 Deficiencies and Plans of Correction

A. The Department shall notify the governing body or other legal authority of a school-based health center of violations of individual standards through a notice of deficiencies which shall be forwarded to the school-based health center within fifteen (15) days of inspection of the school-based health center unless the Director determines that immediate action is necessary to protect the health, welfare, or safety of the public or any member thereof through the issuance of an immediate compliance order in accordance with R.I. Gen. Laws § 23-1-21.

B. A school-based health center which received a notice of deficiencies must submit a plan of correction to the Department within fifteen (15) days of the date of the notice of deficiencies. The plan of correction shall detail any requests for variances as well as document the reasons therefor.

C. The Department will be required to approve or reject the plan of correction submitted by a school-based health center in accordance with § 18.8.2(B) of this Part within fifteen (15) days of receipt of the plan of correction.

D. If the Department rejects the plan of correction, or if the school-based health center does not provide a plan of correction within the fifteen (15) day period stipulated in § 18.8.2(C) of this Part, or if a school-based health center whose plan of correction has been approved by the Department fails to execute its plan within a reasonable time, the Department may invoke the sanctions enumerated in § 18.4.5 of this Part. If the school-based health center is aggrieved by the action of the Department, the school-based health center may appeal the decision and request a hearing in accordance with R.I. Gen. Laws Chapter 42-35.

E. The notice of the hearing to be given by the Department shall comply in all respects with the provisions of R.I. Gen. Laws Chapter 42-35. The hearing shall in all respects comply with the provisions therein.

18.8.3 Rules Governing Practices and Procedures

All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 23-17, shall be held in accordance with the provisions of the rules and regulations regarding Practices and Procedures Before the Department of Health (Part 10-05-4 of this Title) and Access to Public Records (Part 10-05-1 of this Title).

18.8.4 Confidentiality

Disclosure of any health care information relating to individuals shall be subject to the provisions of the Confidentiality Act of R.I. Gen. Laws Chapter 5-37.3 and other relevant statutory and federal requirements.