216 R.I. Code R. § 216-RICR-40-10-4.5 - Organization && Management

4.5.1 Governing Body

A. Each hospital shall have an organized governing body or other legal authority, responsible for:

1. the management and control of the operation of the hospital; and

2. the conformity of the hospital with all federal, state and local laws and regulations relating to fire, safety, sanitation, communicable and reportable diseases; and

3. other relevant health and safety requirements and with these regulations.

B. The governing body shall define the population and communities to be served and the scope of services to be provided.

1. The governing body, through the chief executive officer, shall provide for institutional planning to meet the health needs of the community, in accordance with R.I. Gen. Laws § 23-17-10.

C. The governing body, through its chief executive officer, shall provide appropriate resources and personnel, and shall determine the qualifications of personnel as required in these regulations, considering such factors as education, training, experience, board certification, eligibility to sit for examination of specialty board, evidence of current professional practice and licensure as may be required by law or regulation and such other relevant factor(s) as may be deemed necessary to meet the needs of the patients as well as the health needs of the community.

D. The governing body shall adopt and maintain written by-laws, rules and regulations in accordance with legal requirements and with its defined community responsibility, identifying the purpose of the hospital and the means of fulfilling them. A copy of said by-laws, rules and regulations including amendments or revisions thereto, shall be filed with the licensing agency.

1. Each hospital shall provide the licensing agency written notice of any changes to the hospital's corporate documents, including, but not limited to: charters/articles of incorporation and by-laws, and their equivalents for partnerships and limited liability corporations (LLCs), immediately but no more than thirty (30) days of making such change. Materials provided shall be deemed to be public records.

2. Each hospital shall provide the licensing agency written notice of any changes to the corporate documents of any entity that owns, operates, and/or controls the licensed hospital, including, but not limited to: charters/articles of incorporation and by-laws, and their equivalents for partnerships and limited liability corporations (LLCs), immediately but no more than thirty (30) days of making such change. Materials provided shall be deemed to be public records.

E. The by-laws, rules and regulations shall include:

1. a statement of purpose;

2. a statement of qualifications for membership and method of selecting members of the governing body;

3. provisions for the establishment, selection and term of office of committee members and officers;

4. a description of the functions and duties of the governing body, officers, and committees;

5. specifications for the frequency of meetings, attendance requirements, provisions for the order of business and the maintenance of written minutes;

6. a statement of the authority and responsibility delegated to the chief executive officer and to the medical staff;

7. provision for the selection and appointment of medical staff and the granting of clinical privileges. Such provisions shall include the appointment of a credentialing committee that shall include advance practice clinicians.

a. Physician Contracts

(1) Pursuant to R.I. Gen. Laws § 23-17-53, a hospital, by contract or otherwise, may not refuse or fail to grant or renew medical staff membership or, staff privileges, or condition or otherwise limit or restrict staff privileges, based in whole or in part on the fact that the physician or a partner, associate, or employee of the physician is providing medical or health care services at a different hospital, hospital system or on behalf of a health plan; provided, however, that a hospital may condition or otherwise limit or restrict staff privileges for reasons related to the availability of limited resources as determined in advance by the hospital's governing body. Nor shall a hospital by contract, or otherwise limit a physician's participation or staff privileges or the participation or staff privileges of a partner, associate, or employee of the physician at a different hospital, hospital system or health plan.

(2) This section does not prevent a hospital from entering into contracts with physicians to ensure physician availability and coverage at the hospital or to comply with regulatory requirements or quality of care standards established by the governing body of the hospital, if contracts, requirements or standards do not require that a physician join, participate in or contract with a physician-hospital organization or similar organization as a condition of the grant or continuation of staff privileges at the hospital.

(3) This section does not prevent the governing body of a hospital from limiting the number of physicians granted medical staff membership or privileges at the hospital based on a medical staff development plan that is unrelated to a physician or a partner, associate, or employee of a physician having medical staff membership or privileges at another hospital or hospital system; or

(4) A contract provision that violates this section shall be void and of no force and effect.

8. provision for the approval of the medical staff by-laws, rules and regulations;

9. provision of guidelines for the relationships among the governing body, the chief executive officer, the medical staff and the community;

10. a policy statement concerning the development and implementation of short and long range plans in accordance with R.I. Gen. Laws Chapter 23-17;

11. a policy statement concerning the publication of an annual report, including a certified financial statement;

12. a policy statement relating to conflict of interest on the part of members of the governing body, medical staff and employees who may influence corporate decisions;

13. provision that contracts with outside providers of services be restricted to those which comply with federal, state and local laws and these regulations; and

14. a policy statement relating to the protection of any physician or any other person or employee for non-participation in abortion or sterilization procedures in accordance with R.I. Gen. Laws § 23-17-11.

F. The governing body or other appropriate authority of a hospital is authorized to suspend, deny, revoke or curtail staff privileges of any staff member for good cause in accordance with R.I. Gen. Laws § 23-17-21.

4.5.2 Statewide Standard for the Provision of Charity Care, Uncompensated Care, and Community Benefits

Hospital charity care, uncompensated care, and community benefits standards shall be consistent with the requirements provided in the "Rules and Regulations Pertaining to Hospital Conversions."

4.5.3 Quality Improvement

A. The governing body shall ensure that there is an effective, ongoing, hospital-wide quality improvement program to evaluate the provision of patient care.

B. The organized hospital-wide quality improvement program shall be ongoing and shall have a written plan of implementation. The written quality improvement plan shall include at least the following:

1. program objectives;

2. organization(s) involved;

3. oversight responsibility (e.g., reports to the governing body);

4. hospital-wide scope;

5. program administration and coordination;

6. involvement of all patient care disciplines/services;

7. methodology for monitoring and evaluating quality of care;

8. priority setting and problem resolution;

9. determination of the effectiveness of action(s) taken;

10. documentation of the quality improvement plan review.

C. All patient care services, including services rendered by a contractor, shall be evaluated.

D. Nosocomial infections and medication therapy shall be evaluated.

E. All medical and surgical services performed in the hospital shall be evaluated for appropriateness in diagnosis and treatment. The evaluation shall include peer review of individual cases. The hospital shall maintain records of peer reviews, documenting the case(s) reviewed, focus of each review, findings, conclusions, any actions taken, and any follow-up on actions taken.

F. The hospital 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.

4.5.4 Chief Executive Officer

The chief executive officer shall be directly responsible to the governing body for the management and operation of the hospital and shall provide liaison between the governing body and the medical staff.

4.5.5 Medical Staff

A. Each hospital shall have an organized medical staff responsible for the quality of medical services and accountable to the governing body of the hospital.

B. The medical staff shall be responsible for its organized governance and for all medical care provided to patients.

C. The medical staff shall maintain standards of professional performance through staff appointment criteria, delineation of staff privileges, continuing peer review and other appropriate mechanisms.

D. The medical staff, subject to the approval of the governing body of the hospital, shall adopt by-laws incorporating details of its general powers, duties, and responsibilities including:

1. methods of selection, election or appointment of all officers and other executive committee members and officers;

2. provisions for the selection and appointment of officers of departments or services specifying required qualifications;

3. the type, purpose, composition and organization of standing committees;

4. frequency and requirements for attendance at staff departmental meetings;

5. an appeal mechanism for denial of staff appointments, reappointments and privileges;

6. delineation of clinical privileges of non-physician practitioners;

7. designation of personnel qualified to prescribe or administer drugs;

8. requirements regarding medical records;

9. a mechanism for utilization and medical care review;

10. such provisions as shall be required by hospital or governmental rules and regulations; and

11. provisions for a program permitting selected individuals other than physicians or other licensed, registered or certified personnel to perform extended, defined patient care functions. Said functions shall not otherwise require a license, certification or registration by state law. Such program shall include written systems of credentials review, selection, training, formal authorization of specific functions and maintenance of a current register.

E. A copy of approved medical staff by-laws and regulations and revisions thereto, shall be submitted to the licensing agency.

4.5.6 Organization

A. Each hospital shall maintain clearly written definitions of its organization, authority, responsibility and relationships.

B. Each hospital department and service shall maintain:

1. clearly written definitions of its organization, authority, responsibility and relationships;

2. written patient care policies and procedures; and

3. written provision for systematic evaluation of programs and services.

C. Every licensed hospital and its insurance carrier shall cooperatively, as part of their administrative function, establish an internal risk management program in accordance with the requirements of R.I. Gen. Laws § 23-17-24.

D. All hospitals shall comply with the requirements of R.I. Gen. Laws Chapter 23-18.6.1 and Rhode Island Health Department Rules and Regulations Relating to Procurement of Anatomical Gifts from Persons with Unknown Intent by establishing protocols related to anatomical gifts and all other relevant requirements.

E. Any hospital that utilizes latex gloves shall do so in accordance with the provisions of the Rules and Regulations Pertaining to the Use of Latex Gloves by Health Care Workers, in Licensed Health Care Facilities, and by Other Persons, Firms, or Corporations Licensed or Registered by the Department (Part 20-15-3 of this Title) promulgated by the Department of Health.

4.5.7 Personnel

A. The hospital shall maintain a sufficient number of qualified personnel to provide effective patient care and all other related services.

B. There shall be written personnel policies and procedures which shall be made available to personnel.

C. Provisions shall be made for orientation and ongoing education programs for all personnel. There shall be written evidence that staff demonstrate competencies necessary to work in specific areas and/or with specific patient populations.

D. There shall be a job description for each position which delineates the qualifications, duties, authority and responsibilities inherent in each position.

1. For those authorized to perform defined functions in accordance with §4.5.5(D)(11) of this Part, a job description delineating qualifications, duties, authority and responsibilities shall be provided.

2. For every individual within the hospital who is licensed, certified or registered by the state of Rhode Island, a mechanism shall be in place to verify currency of licensure electronically via the Department's licensure database.

E. There shall be work performance evaluation programs with appropriate records maintained.

F. Non-employee staff (including but not limited to volunteers, per diem staff and contractees) who are working in the hospital must adhere to policies and procedures of the hospital. The hospital must provide for adequate orientation, supervision and evaluation of the activities of non-employee staff.

G. If the hospital does not employ personnel to render required services, or obtains services from an outside source, arrangements for such services shall be made through written agreements or contracts.

1. The responsibilities, functions, objectives, terms of agreement, financial arrangements, charges and other pertinent requirements shall be clearly delineated in the terms of any contract negotiated by the hospital.

2. All contracts or agreements negotiated by the hospital shall be consistent with the provisions established in accordance with §§4.5.1(E)(12) through (13) of this Part.

H. Pursuant to R.I. Gen. Laws § 23-17-2, any hospital licensed pursuant to R.I. Gen. Laws Chapter 23-17, shall provide to all patients and staff, through posted notices in conspicuous places throughout the hospital, the current Center for Health Facility Regulations telephone number to call with concerns. Such notices shall be written in English and, at a minimum, the three most common languages used by patients served by each hospital as determined by such hospital, and shall include the internationally-recognized symbol for sign language (including a relay number for access by hearing/speech impaired (TTY)).

I. In accordance with R.I. Gen. Laws § 23-17-47, a health care facility shall require all persons, including students, who examine, observe or treat a patient or resident of such facility to wear a photo identification badge which states, in a reasonably legible manner, the first name, licensure registration status, if any, and staff position of such person. For hospital designated interpreters and bilingual clinicians, include fluency in sign languages or language other than English, if any, and staff position of such person on the badge. This badge shall be worn in a manner that makes the badge easily seen and read by the patient or visitor.

J. Health Screening

Upon hire and prior to delivering services, pre-employment health screenings shall be required for each individual who has or may have direct contact with a patient in the hospital. 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) promulgated by the Department of Health.

K. Safe Patient Handling

Each licensed hospital shall comply with the following as a condition of licensure:

1. Each licensed hospital shall establish a safe patient handling committee, which shall be chaired by a professional nurse or other appropriate licensed health care professional. A hospital may utilize any appropriately configured committee to perform the responsibilities of this section. At least half of the members of the committee shall be hourly, non-managerial employees who provide direct patient care.

2. Each licensed hospital shall develop a written safe patient handling program, with input from the safe patient handling committee, to prevent musculoskeletal disorders among health care workers and injuries to patients. As part of this program, each licensed health care facility shall:

a. Implement a safe patient handling policy for all shifts and units of the facility that will achieve the maximum reasonable reduction of manual lifting, transferring, and repositioning of all or most of a patient's weight, except in emergency, life-threatening, or otherwise exceptional circumstances;

b. Conduct a patient handling hazard assessment. This assessment should consider such variables as patient-handling tasks, types of nursing units, patient populations, and the physical environment of patient care areas;

c. Develop a process to identify the appropriate use of the safe patient handling policy based on the patient's physical and mental condition, the patient's choice, and the availability of lifting equipment or lift teams. The policy shall include a means to address circumstances under which it would be medically contraindicated to use lifting or transfer aids or assistive devices for particular patients;

d. Designate and train a registered nurse or other appropriate licensed health care professional to serve as an expert resource, and train all clinical staff on safe patient handling policies, equipment, and devices before implementation, and at least annually or as changes are made to the safe patient handling policies, equipment and/or devices being used;

e. Conduct an annual performance evaluation of the safe patient handling with the results of the evaluation reported to the safe patient handling committee or other appropriately designated committee. The evaluation shall determine the extent to which implementation of the program has resulted in a reduction in musculoskeletal disorder claims and days of lost work attributable to musculoskeletal disorder caused by patient handling, and include recommendations to increase the program's effectiveness; and

f. Submit an annual report to the safe patient handling committee of the facility, which shall be made available to the public upon request, on activities related to the identification, assessment, development, and evaluation of strategies to control risk of injury to patients, nurses and other health care workers associated with the lifting, transferring, repositioning, or movement of a patient.

3. Nothing in this section precludes lift team members from performing other duties as assigned during their shift.

4. An employee may, in accordance with established facility protocols, report to the committee, as soon as possible, after being required to perform a patient handling activity that he/she believes in good faith exposed the patient and/or employee to an unacceptable risk of injury. Such employee reporting shall not be cause for discipline or be subject to other adverse consequences by his/her employer. These reportable incidents shall be included in the facility's annual performance evaluation.

L. Overtime Requirement

All hospitals shall be in compliance with the provisions of R.I. Gen. Laws Chapter 23-17.20.

M. Credentialing of Advanced Practice Clinicians

1. All advanced practice clinicians shall be appropriately credentialed by the hospital.

2. All advanced practice clinicians shall be credentialed through the medical staff appointment process and shall be subject to continuing quality assurance review by medical staff mechanisms.

3. The medical staff shall delineate clinical privileges granted to advanced practice clinicians and shall communicate same in accordance with hospital policies.

4. The hospital shall document clinical privileges granted to advance practice clinicians. These documents shall be reviewed no less than every two (2) years by the medical staff so as to reflect current operations within the hospital and the continued competency of the advanced practice clinician.

4.5.8 Professional Library

A. The hospital shall provide appropriate library services for the professional and technical needs of hospital personnel including:

1. current books, periodicals and other pertinent materials;

2. appropriate computer resources for literature search and retrieval;

3. adequate facilities; and

4. adequate personnel to maintain the library service.

4.5.9 Rights of Patients

A. Every hospital shall observe the following standards with respect to each patient who is admitted to its facility as enumerated in R.I. Gen. Laws §§ 23-17-19.1 and 40.1-5-5.

1. The hospital shall inform the patient of the right to include a written durable power of attorney and/or living will into his/her medical record.

B. A copy of the Rights of Patients shall be given to each patient or his/her representative upon admission and shall be posted in a conspicuous place on the premises.

C. Patient Visitation Rights

1. All health care providers, as licensed under the provisions of R.I. Gen. Laws Chapters 5-29 and 5-37 and all health care facilities, as defined in R.I. Gen. Laws § 23-17-2, shall be required to note in their patients' permanent medical records, the name of individual(s) not legally related by blood or marriage to the patient, who the patient wishes to be considered as immediate family member(s), for the purpose of granting extended visitation rights to said individual(s), so said individual(s) may visit the patient while he or she is receiving inpatient health care services in a health care facility.

a. The patient visitation provisions set forth in this section shall not prohibit a hospital from establishing reasonable policies related to the number of visitors each patient may have at any one time.

2. A patient choosing to designate said individual(s) as immediate family members for the purpose of extending visitation rights may choose up to five (5) individuals and do so either verbally or in writing. This designation shall be made only by the patient and can be initiated and/or rescinded by the patient at any time, either prior to, during, or subsequent to an inpatient stay at the health care facility.

3. The full names of individual(s) so designated, along with their relationship to the patient, shall be recorded in the patient's permanent medical records, both at the inpatient health care facility and with the patient's primary care physician.

4. In the event the patient has not had the opportunity to have said designation recorded in his or her medical records, a signed statement in the patient's own handwriting attesting to the designation of said individual(s) as an immediate family member for the purpose of extending visitation right during the provision of health care services in an inpatient health care facility, along with their relationship to said individual(s) shall meet all the requirements of this section. The patient's signature on said signed statement shall be witnessed by two individuals, neither of whom can be the designated individual(s). In the event such signed statement is not available, those designated as agents on a durable power of attorney for health care form shall be allowed visitation privileges.

5. This section shall not be construed to prohibit legally recognized members of the patient's family from visiting the patient if they have not been so designated through the provisions of this section. No patient shall be required to designate individual(s) under the provisions of this section.

D. Concern Line

1. Pursuant to R.I. Gen. Laws § 23-17-52, any hospital licensed pursuant to R.I. Gen. Laws Chapter 23-17, shall provide to all patients and staff, through posted notices in conspicuous places throughout the hospital, the current Center for Health Facility Regulations telephone number to call with concerns.

2. Such notices shall be written in English and, at a minimum, the three most common languages used by patients and staff served by each hospital as determined by such hospital, and shall include the internationally-recognized symbol for sign language (including a relay number for access by hearing/speech impaired (TTY)).

4.5.10 Research Involving Human Subjects

A. A hospital that conducts research involving human subjects shall comply with all applicable state and federal laws, rules and regulations, including any required review and approval by an Institutional Review Board (IRB). The hospital shall have written polices and procedures governing research activities.

B. If the hospital conducts research involving human subjects who are not otherwise patients of the hospital (i.e., not receiving inpatient, outpatient, or emergency services) the following requirements shall be met:

1. There shall be a written protocol for each research study which, at a minimum, describes the nature and purpose of the study, the procedures to be utilized, the extent and type of assessment/testing of subjects, the risks of participation, the content of and subject's access to records to be maintained, and provisions regarding confidentiality and disclosure of information.

2. Each subject shall be advised of the items listed in §4.5.10(B)(1) of this Part, as well as his/her rights and responsibilities, and shall agree to participate in the research study. The use of written consent shall apply to all research participants, except those identified in the federal regulations that guide IRBs in the protection of human subjects (45 C.F.R. §§ 46.116 through 46.117 (2017)), and where the requirement for written consent has been explicitly waived by the hospital's IRB. Also, written consent shall not be required for studies that are exempt from IRB review (45 C.F.R. § 46.101 (2017)). Studies conducted using information abstracted from existing records in anonymous form shall not have a requirement of directly contacting individuals involved in the research.

a. In accordance with R.I. Gen. Laws § 23-17-19(10), except as otherwise provided in this subparagraph, if the health care facility proposes to use the patient in any human subjects research, it shall first thoroughly inform the patient of the proposal and offer the patient the right to refuse to participate in the project.

b. No facility shall be required to inform prospectively the patient of the proposal and the patient's right to refuse to participate when:

(1) the facility's human subjects research involves the investigation of potentially lifesaving devices, medications and/or treatments and the patient is unable to grant consent due to a life-threatening situation and consent is not available from the agent pursuant to R.I. Gen. Laws. Chapter 23-4.10 or the patient's decision maker if an agent has not been designated or an applicable advanced directive has not been executed by the patient; and

(2) the facility's institutional review board approves the human subjects research pursuant to the requirements of 21 C.F.R. §§ 50.20 through 50.27 (2017) and/or 45 C.F.R. §§ 46.116 through 46.117 (2017) (relating to the informed consent of human subjects).

c. Any health care facility engaging in research pursuant to the requirements of this section shall file a copy of the relevant research protocol with the Department, which filing shall be publicly available.

3. Hospital standards and procedures shall be observed in all clinical activities involving research subjects (e.g., phlebotomy or other specimen collection, EKG, etc.) unless deviation from standard procedures is integral to the research, in which case this shall be described in the written study protocol.

4. There shall be written procedures pertaining to the control, accountability, security, administration, and maintenance of records of receipt and disposition of all drugs and biologicals utilized in each research study.

5. If research staff become aware of any clinical condition/concern which may warrant further assessment or treatment, he/she shall promptly notify the subject and advise follow-up with a health care provider.

6. Records regarding a subject are exempt from the requirements of §4.6.10 of this Part (medical records) but shall be maintained in conformance to the written study protocol. Subject records, either original or accurate reproduction, shall be maintained for a minimum of five (5) years.

7. In addition to the requirements of §4.5.7 of this Part, there shall be evidence that all staff participating in a research study have received training in the specific protocols to be applied.

8. Research activities involving human subjects who are not otherwise patients of the hospital shall be exempt from the requirements of §4.5.3 of this Part. However, there shall be a quality assurance program in effect to ensure conformance to the written study protocols. Quality assurance activities may be documented in the study protocol.

4.5.11 Uniform Reporting System

A. Each hospital shall establish and maintain records and data in such a manner as to make uniform the system of periodic reporting. The manner in which the requirements of this regulation may be met shall be prescribed from time to time in directives promulgated by the Director with the advice of the Health Services Council.

B. Each hospital shall report to the licensing agency detailed financial and statistical data pertaining to its operations, services, and facilities. Such reports shall be made at such intervals and by such dates as determined by the Director and shall include but not be limited to the following:

1. utilization of inpatient and outpatient hospital facility and services;

2. unit cost of hospital services;

3. charges for rooms and services;

4. audited financial statements for both hospital and any parent corporation/foundation; and

5. quality of hospital care.

C. The licensing agency is authorized to make the reported data available to any state agency concerned with or exercising jurisdiction over the reimbursement or utilization of hospitals.

D. The directives promulgated by the Director pursuant to these regulations shall be sent to each hospital to which they apply. Such directives shall prescribe the form and manner in which the financial and statistical data required shall be furnished to the licensing agency.

4.5.12 Inpatient, Emergency Department, and Observation Unit Data

A. All licensed hospitals in this state shall be subject to the uniform reporting of financial and statistical data on hospital inpatient services, emergency department services, and observation unit services in accordance with the technical and data specifications contained in Rhode Island Hospital Discharge Data Reporting Manual, Rhode Island Emergency Department Data Reporting Manual, and Rhode Island Observation Services Data Reporting Manual.

1. Data submitted in accordance with §4.5.12 of this Part shall contain only the medical record number or the hospital assigned number and no other patient identifying information to ensure anonymity of the reported data.

2. The Department shall provide licensed hospitals with no less than a twenty (20) day comment period after issuing or changing the reporting requirements.

a. Licensed hospitals shall have a period of at least ninety (90) days after the comment period to comply with new or changed reporting requirements.

Notes

216 R.I. Code R. § 216-RICR-40-10-4.5