TITLE 16

Health and Safety

Regulatory Provisions Concerning Public Health

CHAPTER 10. Hospitals

§ 1001. “Hospital” defined [For application of this section, see 83 Del. Laws, c. 102, § 2] .

(a) As used in this chapter, “hospital” means a health-care organization that has a governing body, an organized medical and professional staff, and inpatient facilities, and provides either medical diagnosis, treatment and care, nursing and related services for ill and injured patients, or rehabilitation services for the rehabilitation of ill, injured or disabled patients 24 hours per day, 7 days per week and primarily engaged in providing inpatient services.

(b) Hospitals may be further classified as:

(1) General. — Providing diverse patient services, diagnostic and therapeutic, for a variety of medical conditions. A general hospital must provide on-site:

a. Diagnostic x-ray services with facilities and staff for a variety of procedures.

b. Clinical laboratory services with facilities and with anatomical pathology services regularly and conveniently available available.

c. Operating room service with facilities and staff.

d. Emergency department with facilities and staff.

(2) Long-term care. — Providing inpatient services for patients whose medically-complex conditions require a long hospital stay with an average length of stay of greater than 25 days.

(3) Psychiatric. — Providing services for the diagnosis and treatment of patients with psychiatric-related illness.

(4) Rehabilitation. — Providing intensive inpatient rehabilitative services for 1 or more conditions requiring rehabilitation.

(5) Surgical. — Providing inpatient and outpatient surgical and related services in which the anticipated duration of the patient’s stay will not exceed 72 hours following admission. A surgical hospital must provide all of the following services on-site:

a. Diagnostic x-ray services with facilities and staff for a variety of procedures.

b. Clinical laboratory services with facilities and anatomical pathology services regularly and conveniently available.

c. Operating room service with facilities and staff.

d. Basic emergency care.

(c) Hospitals classified under paragraphs (b)(2) through (4) of this section shall not be required to comply with the provisions of paragraph (b)(1) of this section, but must, at a minimum, provide on-site basic emergency care services.

16 Del. C. 1953, §  1021;  56 Del. Laws, c. 36070 Del. Laws, c. 149, §  8770 Del. Laws, c. 186, §  180 Del. Laws, c. 404, §  182 Del. Laws, c. 73, § 183 Del. Laws, c. 102, § 1

§ 1002. Regulations.

(a) The Department shall develop, establish and enforce standards governing the construction, maintenance and operation of hospitals to protect and promote the public health and welfare.

(b) The Department shall further adopt regulations to ensure that hospital staff have ready access to a locked hospital bathroom in the event of an emergency.

16 Del. C. 1953, §  1027;  56 Del. Laws, c. 36070 Del. Laws, c. 149, §  9270 Del. Laws, c. 186, §  179 Del. Laws, c. 243, §  182 Del. Laws, c. 73, § 1

§ 1003. License requirement.

(a) No person shall construct, establish, conduct or maintain a hospital in this State without a license being issued under this chapter.

(b) A license is not transferable from person to person or entity to entity.

(c) Separate licenses.

(1) Separate licenses are required for hospitals maintained on separate premises, even though both hospitals may be operated under the same management.

(2) Separate licenses are not required for separate buildings on the same grounds or adjoining grounds, if the buildings are operated under 1 management.

(3) All off-site ambulatory care service facilities must be licensed as free-standing facilities if identified as such in § 122(3) of this title.

16 Del. C. 1954, §  1023;  56 Del. Laws, c. 36082 Del. Laws, c. 73, § 1

§ 1004. Application for license.

An application for license shall be made to the Department upon forms provided by it and shall contain such information as the Department may reasonably require including affirmative evidence of ability to comply with such reasonable standards, rules and regulations as are lawfully prescribed under this chapter.

16 Del. C. 1953, §  1024;  56 Del. Laws, c. 36070 Del. Laws, c. 149, §  8870 Del. Laws, c. 186, §  182 Del. Laws, c. 73, § 1

§ 1005. Issuance and renewal of license.

(a) The Department shall grant an initial license for a period of up to 1 year to a new hospital that completes the application process, submits the nonrefundable application fee of $1,000 plus $2 per licensed inpatient bed and $500 for each emergency department not located on the hospital’s main campus, and demonstrates compliance with the requirements established under this chapter.

(b) The Department shall renew annually a hospital’s license, unless suspended or revoked, upon filing by the hospital, payment of an annual licensure fee of $750 plus $2 per licensed inpatient bed and $500 for each emergency department not located on the hospital’s main campus, and demonstration of its continued compliance with the requirements established under this chapter.

(c) The Department may grant a provisional license to a hospital which is not in substantial compliance with the requirements established under this chapter. A hospital which has been issued a provisional license shall resubmit the initial application fee for reinspection prior to the issuance of an annual license.

(d) The licensure fees collected by the Department pursuant to this section are hereby appropriated to, and shall be retained by, the Department to defray operating expenses associated with this chapter.

16 Del. C. 1953, §  1025;  56 Del. Laws, c. 36067 Del. Laws, c. 266, §  570 Del. Laws, c. 149, §  8970 Del. Laws, c. 186, §  182 Del. Laws, c. 73, § 1

§ 1006. Denial or revocation of license, hearings and appeal.

(a) The Department shall have the authority to deny, suspend, or revoke a license in any case where it finds that there has been a failure to comply with this chapter or the rules and regulations issued under this chapter or the Health-Care Associated Infections Disclosure Act [Chapter 10A of this Title] § 1731A of Title 24 or § 903 of this title.

(b) Before a license issued under this chapter is denied, suspended or revoked, notice shall be given in writing to the holder of the license setting forth the particular reasons for such action. Denial, suspension or revocation of a license shall become effective 30 days after the mailing by registered mail or personal service of the notice, unless the applicant or licensee within such 30 day period shall give written notice to the Department requesting a hearing, in which case the notice shall be deemed to be suspended. If a hearing has been requested, the applicant or licensee shall be given an opportunity for a prompt and fair hearing before the Department. At any time at or prior to the hearing, the Department may rescind the notice of denial, suspension or revocation, upon being satisfied that the reasons for such action have been or will be removed. A copy of the decision of the Department setting forth the finding of facts and the particular reasons for the decision shall be sent by registered mail or served personally upon the applicant or licensee. The decision shall become final 30 days after it is so mailed or served unless the applicant or licensee within such 30-day period appeals the decision to the Superior Court. A copy of said notice of appeal must be provided simultaneously to the Department. The Department shall promptly certify and file with the Court a copy of the record and decision, including the transcript of the hearings on which the decision is based. Proceedings thereafter shall be governed by the Rules of the Superior Court of the State.

(c) The procedure governing hearings authorized by this section shall be in accordance with rules promulgated by the Department. A full and complete record shall be kept of all proceedings and all testimony.

16 Del. C. 1953, §  1026;  56 Del. Laws, c. 36070 Del. Laws, c. 149, §§  90, 9170 Del. Laws, c. 186, §  176 Del. Laws, c. 122, §  277 Del. Laws, c. 320, §  782 Del. Laws, c. 73, § 1

§ 1007. Enforcement.

(a) Any person constructing, managing or operating any hospital without a license shall be fined not more than $5,000 for the first offense and not more than $10,000 for each subsequent offense. Each day of a continuing violation shall be considered a separate offense.

(b) The Department may impose civil money penalties for the violation of provisions of this chapter or the regulations adopted pursuant to it.

(1) A licensee or other person is liable for a civil money penalty of not more than $10,000 per violation for violations which the Department determines pose a serious threat to the health and safety of a patient. Each day a violation continues constitutes a separate violation.

(2) In determining the amount of a civil money penalty imposed pursuant to subsection (a) of this section or this subsection, the Department shall consider the following factors:

a. The seriousness of the violation, including the nature, circumstances, extent and gravity of the violation and the threat or potential threat to the health or safety of patients;

b. The history of violations committed by the person or the person’s affiliate, employee, or controlling person;

c. The efforts made by the hospital to correct the violation;

d. Any misrepresentation made to the Department; and

e. Any other matter that affects the health, safety or welfare of a patient.

(c) The Department shall have the authority to collect any civil money penalty. Any civil money penalties collected by the Department under this section are hereby appropriated to the Department to carry out the purposes of this section.

(1) Payment of any civil penalty by a facility is not an allowable cost for reimbursement under the state Medicaid program or under other state-funded programs.

(2) In the event of nonpayment of a civil money penalty the Department may add the amount of the civil penalty to the licensing fee for the hospital. If the licensee refuses to make the payment at the time of the application for renewal of its license its license may not be renewed.

(3) In the event of nonpayment of a civil money penalty after all legal appeals have been exhausted, a civil action may be brought by the Secretary in Superior Court for collection of the civil money penalty, including interest, attorney fees and costs. In a civil action to collect the civil money penalty the validity, amount and appropriateness of the civil money penalty shall not be subject to review.

16 Del. C. 1953, §  1027;  56 Del. Laws, c. 36070 Del. Laws, c. 149, §  9270 Del. Laws, c. 186, §  179 Del. Laws, c. 243, §  182 Del. Laws, c. 73, § 1

§ 1008. Injunction.

Notwithstanding the existence or pursuit of any other remedy, the Department may, in the manner provided by law, maintain an action in the name of the State for injunction or other process against any person to restrain or prevent the construction, maintenance or operation of a hospital without a license.

16 Del. C. 1953, §  1036;  56 Del. Laws, c. 36070 Del. Laws, c. 149, §  9870 Del. Laws, c. 186, §  182 Del. Laws, c. 73, § 1

§ 1009. Construction.

(a) All construction, whether new or renovation, must conform to the design and construction standards established by the Department.

(1) A “renovation” is:

a. The strengthening or upgrading of building elements, materials, equipment, or fixtures that does not result in a reconfiguration of the building spaces within; or

b. Any reconfiguration of a space that affects an exit, a corridor, or any component of a means of egress; or

c. Work that changes the current designated purpose or occupancy classification of a building space.

(2) Cosmetic changes such as repainting or changing carpeting are not considered renovations.

(b) When a hospital plans to construct or renovate any buildings or spaces within a building, 2 copies of properly-prepared plans and specifications for the entire project shall be submitted to the Department.

(c) An approval, in writing, shall be obtained from the Department before construction or renovation work is begun.

(d) Hospitals wishing to construct or renovate must apply to the Department and submit the appropriate fee for approval. The fee structure for plan review shall be as follows:

New Construction

Square footage Fee
10,000 or less $250
10,001-20,000 $300
20,001-30,000 $350
30,001-40,000 $400
40,001-50,000 $450
50,001-above $500

Renovations

Square footage Fee
5,000 or less $100
5,001-10,000 $150
10,001-15,000 $200
15,001-20,000 $250
20,001-25,000 $300
25,001-30,000 $350
30,001-35,000 $400
35,001-40,000 $450
40,001-above $500

(e) After the hospital has submitted all required documentation, the Department shall review the submission within a timeframe agreed upon by both parties.

(f) Hospitals failing to complete the plan review process and receive approval prior to construction or renovation shall be subject to a $5,000 fine for each project.

(g) Any licensure fees or fines collected by the Department pursuant to this section are hereby appropriated to, and shall be retained by, the Department to defray operating expenses associated with this chapter.

82 Del. Laws, c. 73, § 1

§ 1010. Inspections and investigations.

(a) The Department shall make or cause to be made such inspections and investigations of a hospital as it may deem necessary.

(b) The Department shall accept the survey report of an approved accrediting organization, as defined by regulations, in lieu of an annual licensure inspection.

16 Del. C. 1953, §  1029;  56 Del. Laws, c. 36070 Del. Laws, c. 149, §  9470 Del. Laws, c. 186, §  182 Del. Laws, c. 73, § 1

§ 1011. Compliance.

All hospitals must comply with applicable federal, state, county and local laws and regulations.

82 Del. Laws, c. 73, § 1

§ 1012. Reportable events.

(a) Hospitals must report all major adverse incidents involving a patient to the Department within 10 calendar days.

(1) A major adverse incident is a patient safety event (not primarily related to the natural course of the patient’s illness or underlying condition) that reaches a patient. The Department shall define “major adverse incident” and provide further clarification in regulation.

(2) Major adverse incidents must be investigated by the hospital.

(3) A summary of the hospital’s investigative findings will be forwarded to the Department within a timeframe agreeable to both parties.

(b) Hospitals must notify the Department immediately of any event occurring within the hospital that jeopardizes the health or safety of patients or employees including:

(1) An unscheduled interruption for 3 or more hours of physical plant or clinical services impacting the health or safety of patients or employees.

(2) A fire, disaster or accident which results in evacuation of patients out of the hospital.

(3) An alleged or suspected crime which endangers the life or safety of patients or employees, which is also reportable to the police department, and which results in an immediate on-site investigation by the police.

(4) An alleged incident of medication diversion, as defined under § 1131 of this title.

(c) Information submitted as a major adverse incident is considered peer review information and not subject to public disclosure except as aggregate data.

16 Del. C. 1953, §  1033;  56 Del. Laws, c. 36070 Del. Laws, c. 149, §  9670 Del. Laws, c. 186, §  182 Del. Laws, c. 73, § 183 Del. Laws, c. 22, § 11

§ 1013. Designation of hospitals as primary stroke centers.

(a) The Secretary of Health and Social Services shall designate as a comprehensive stroke center any acute care hospital within Delaware, or an out-of-state acute care hospital upon request, which has received Advanced Certification for Comprehensive Stroke Centers issued by the Joint Commission or an equivalent certification by another nationally-recognized guidelines-based accrediting organization as determined by the Secretary.

(b) The Secretary of Health and Social Services shall designate as a primary stroke center any acute care hospital within Delaware, or an out-of-state acute care hospital upon request, which has received Advanced Certification for Primary Stroke Centers issued by the Joint Commission or an equivalent certification by another nationally-recognized guidelines-based accrediting organization as determined by the Secretary.

(c) The Secretary of Health and Social Services shall designate as an acute stroke ready center any acute health-care facility within Delaware, or an out-of-state acute health-care facility upon request, which has received Advanced Certification for Acute Stroke Ready Centers issued by the Joint Commission or an equivalent certification by another nationally-recognized guidelines-based accrediting organization as determined by the Secretary.

(d) The Secretary of Health and Social Services shall designate as a thrombectomy-capable stroke center any acute health-care facility within Delaware, or an out-of-state acute health-care facility upon request, which has received Advanced Certification for Thrombectomy-Capable Stroke Centers issued by the Joint Commission or an equivalent certification by another nationally-recognized guidelines-based accrediting organization as determined by the Secretary.

(e) The Secretary of Health and Social Services may establish other distinct categories of stroke center certification if additional categories are established by the Joint Commission or by an equivalent nationally recognized guidelines-based accrediting organization as determined by the Secretary, and may designate any acute health-care facility as such based on certification by the Joint Commission or other nationally-recognized guidelines-based accrediting organization.

(f) The Secretary of Health and Social Services shall suspend or revoke a facility’s designation as a comprehensive stroke center, primary stroke center, acute stroke ready center or other categorization if the Joint Commission or equivalent nationally-recognized guidelines-based accrediting organization as determined by the Secretary suspends or revokes a facility’s certification.

76 Del. Laws, c. 299, §  180 Del. Laws, c. 404, §  282 Del. Laws, c. 73, § 1

§ 1014. Hospital visitation policy.

(a) Each hospital shall include in its visitation policy a provision allowing each competent adult patient to receive visits from any individual from whom a patient desires to receive visits, subject to restrictions contained in the visitation policy related to a patient’s medical condition, the number of visitors simultaneously permitted in a patient’s room, and the hospital’s visitation hours, as well as protective orders issued by a court.

(b) The duties and rights conferred by this section are in addition to, and not in derogation of, duties and rights otherwise conferred by law, including §§ 2508 and 5161 of this title.

(c) Nothing in this chapter shall preclude a hospital from restricting visitations due to:

(1) Attempts to interfere with patient care; or

(2) The presentation of a threat to staff, patients or hospital personnel; or

(3) Actions disruptive to hospital operations; or

(4) Pandemic or infectious disease outbreak.

(d) Except as provided in subsection (c) of this section, nothing in this section shall be read to overrule any decision of the Delaware Department of Correction.

77 Del. Laws, c. 49, §  182 Del. Laws, c. 73, § 1

§ 1015. Confidentiality of proprietary information.

Information obtained by the Secretary under this chapter shall be available to the public as provided in Chapter 100 of Title 29, unless the Secretary certifies such information to be proprietary. The Secretary may make such certification where any person shows to the satisfaction of the Secretary that the information, or parts thereof, if made public, would divulge methods, processes or activities entitled to protection as trade secrets or as confidential financial or commercial information. Nothing in this section shall be construed as limiting the disclosure of information by the Secretary to any officer, employee or authorized representative of the state or federal government to effectuate the purposes of this chapter. Furthermore, nothing in this section shall prevent the Secretary from including in the remedial decision record information concerning the cost of the remedy or the manner in which it is performed. Prior to disclosure of information certified by the Secretary to be proprietary to an authorized representative who is not an officer or employee of the state or federal government, the person providing the proprietary information may require the representative to sign an agreement prohibiting disclosure of such information to anyone not authorized by this chapter or the terms of the agreement. Such agreement shall not preclude disclosure by the representative to any state or federal government officer or employee concerned with effecting this chapter.

77 Del. Laws, c. 49, §  182 Del. Laws, c. 73, § 1