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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsJune 2016

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Regulatory Flexibility Act Form

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Statutory Authority: 16 Delaware Code, Section 122(3) (16 Del.C. §122(3))
16 DE Admin. Code 4202
Copies of the proposed regulations are available for review in the June 1, 2016 edition of the Delaware Register of Regulations, accessible online at: or by calling the DPH at (302) 744-4951.
"Carrier" means a person who harbors pathogenic organisms of communicable disease but who does not show clinical evidence of the disease and serves as a potential source of infection.
“Case" means a person whose body has been invaded by an infectious agent with the result that clinical symptoms have occurred.
"Child Care Facility" means any organization or business created for, and having as its major purpose, the daily care and/or education of children under the age of 7 years.
"Communicable Disease" see “Contagious Disease”.
"Contact" means a person or animal that has been in such association with an infected person or animal or a contaminated environment as to have had exposure to the infection.
"Contagious Disease" means an infectious disease that can be transmitted from person to person, or animal to person.
Designee means the person named by the Director of the Division of Public Health to assume a specific responsibility.
"Division" means the Division of Public Health.
Division Director means the Director of the Division of Public Health.
Directly Observed Therapy (DOT) means an adherence-enhancing strategy in which a health care worker or other designated person observes the patient to ensure each dose of medication is swallowed.
"Epidemic" or "Outbreak" means the occurrence in persons in a community, institution, region, or other defined area of cases of an illness of similar nature clearly in excess of normal expectancy.
"Health care provider" means any person or entity who provides health care services, including, but not limited to, hospitals, medical clinics and offices, special care facilities, medical laboratories, physicians, pharmacists, dentists, physician assistants, nurse practitioners, registered and other nurses, paramedics, emergency medical or laboratory technicians, and ambulance and emergency medical workers.
HIV Infection” means the presence of repeatedly reactive screening tests for HIV antibody in accord with the Centers for Disease Control and Prevention case definition of HIV and DPH Laboratory endorsed diagnostic protocols.
"Infectious disease" means a disease caused by a living organism or other pathogen, including a fungus, bacillus, parasite, protozoan or virus. An infectious disease may or may not be transmissible from person to person or animal to person.
"Isolation" means the physical separation and confinement of an individual or group of individuals who are infected or reasonably believed to be infected with a contagious or possibly contagious disease from non-isolated individuals to prevent or limit the transmission of the disease.
"Medical Examiner" means a physician appointed pursuant to 29 Del.C. §4703 or 7903(a)(3) who is authorized to investigate the causes and circumstances of death.
"Nosocomial Disease" means a disease occurring in a patient in a health-care facility and in whom it was not present or incubating at the time of admission. Also known as Healthcare Associated Infection.
"Notifiable Disease" means an infectious disease or condition of public health significance required to be reported to the Division of Public Health in accordance with these Rules.
"Notification" means a written, electronic, or verbal report as required by any section of these Rules.
"Outbreak" - Refer to definition of "Epidemic".
Post-Secondary Institution includes post-high school institutions of education/training, such as universities, private colleges, technical and community colleges, vocational technical schools and hospital nursing schools.
“Public Health Emergency” is an occurrence or imminent threat of an illness or health condition that is believed to be caused by any of the following:
"Quarantine" means the physical separation and confinement of an individual or group of individuals who are or may have been exposed to a contagious or possibly contagious disease but who do not yet show signs or symptoms of the contagious disease from non-quarantined individuals to prevent or limit the transmission of the disease.
Resistant Organism means any organism which traditionally was inactivated or killed by a drug but has, over time, developed mechanisms to render that drug ineffective. Also known as Drug Resistant Organism.
"Sensitive Situation" means a setting, as judged by the Director of the Division of Public Health or designee in which the presence of a person or animal infected with or suspected of being infected with a notifiable or other communicable disease or condition which may affect the public health would increase significantly the probability of spread of such disease and would, therefore, constitute a public health hazard, but not a public health emergency as defined in Title 20 3132(11) of the Delaware Code. Sensitive situations may include, but are not limited to, schools, child-care facilities, hospitals, and other patient-care facilities, food storage, food processing establishments or food outlets.
"Source of Infection" means the person, animal, object or substance from which an infectious agent passes directly to the host.
"Suspect" means a person or animal whose medical history and symptoms suggest that he or it may have or may be developing an infectious disease condition.
"Syndromic Surveillance" is surveillance using signs and symptoms that precede diagnosis and may signal a sufficient probability of a case or an outbreak to warrant further public health response.
2.2.1 Reports pursuant to this subsection shall be made electronically, by telephone, by facsimile (fax), or in writing within 48 hours of recognition to the Division Director or designee, except as otherwise noted in these regulations or specified in the Appendices to these regulations.
6.10 The provisions of this section are subject to the provisions of Title 16, Sections 520-532 of the Delaware Code. Provisions of 16 Delaware Code, Sections 520-532 that conflict with provisions of this section take precedence over this section.
7.0 Control of Specific Contagious Diseases
7.3.1 Appendix I lists STDs regarded to cause significant morbidity and mortality, can be screened, diagnosed and treated, or are of major public health concerns such that surveillance of the disease occurrence is in the public interest, and therefore shall be designated as sexually transmitted and reportable pursuant to 16 Del.C. Ch. 7. For the purposes of this section, a suspect is any person having positive or clinical findings of a STD or in whom epidemiologic evidence indicates a STD may exist; or is identified as a sexual contact of a STD case, and is provided treatment for the STD on that basis. All reports and notification made pursuant to this section are confidential and protected from release except under the provisions of Title 16 Del. Code, §710, and §711. From information received from laboratory notifications, the Division of Public Health may contact attending physicians. The Division of Public Health shall inform the attending physician, if the notification indicates the person has an attending physician, before contacting a person from whom a specimen was obtained. However, if delays resulting from informing the physician may enhance the spread of the STD, or otherwise endanger the health of either individuals or the public, the Division of Public Health may contact the person without first informing the attending physician. The Division of Public Health will evaluate its procedures for HIV/AIDS named-based reporting on a continuous basis for timeliness, completeness of reporting, and security of confidential information. All reports and notification made pursuant to this section are confidential and protected from release except under the provisions of 16 Del.C. §710, §711 and §1201-4, §1201A-4A. Any person aggrieved by a violation of this Section shall have a right of action in the Superior Court and may recover for each violation: Reasonable efforts have been made to counsel the patient pursuant to 16 Del.C. §1202(e), urging the patient to notify the partner, and the patient has refused or is considered to be unlikely to notify the partner.
"Agency for Healthcare Research and Quality (AHRQ)" is an agency of the United States Department of Health and Human Services that works to improve the quality, safety, efficiency, and effectiveness of healthcare for all Americans and supports research that improves the quality of healthcare services.
Centers for Disease Control and Prevention (CDC)” is an agency of the United States Department of Health and Human Services that works to protect public health and safety by providing information to enhance health decisions and promoting health through partnerships with state health departments and other organizations. The CDC is dedicated to protecting health and promoting quality of life through the prevention and control of disease, injury, and disability. As the national public health agency for the United States, the CDC is committed to programs that reduce the health and economic consequences of leading causes of death and disability, thereby ensuring a long, productive, healthy life for all people. The CDC provides the standard national measures for healthcare-associated infections as well as analytic tools that enable each facility to assess its progress and identify where additional prevention and/or response efforts are needed.
Centers for Medicaid and Medicare Services (CMS) is a branch of the United States Department of Health and Human Services that administers Medicare, Medicaid, and the Children’s Health Insurance Program. CMS utilizes a system of payment for operating costs of healthcare facilities based on prospectively set rates. Rulings set forth by CMS have included specifications for use of NHSN for reporting certain healthcare-associated infections and other quality indicators for the purposes of monitoring and improving patient safety and quality of care.
Correctional Facility” means any medical unit operated within any Department of Correction facility in this State.
Department” means the Department of Health and Social Services.
Dialysis center means a facility approved to furnish outpatient dialysis services directly to End Stage Renal Disease (ESRD) patients. Outpatient dialysis centers include staff-assisted dialysis (dialysis performed by the staff of the facility). ESRD is that stage of renal impairment that appears irreversible and permanent, and requires a regular course of dialysis or kidney transplantation to maintain life.
Freestanding surgical center (FSSC) means a facility that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization. The term does not include (1) a facility that is licensed as part of a hospital; (2) a facility that provides services or accommodations for patients who stay overnight; or (3) a facility that is used as an office or clinic for the private practice of a physician, podiatrist, or dentist.
Healthcare-Associated Infection (HAI)means a localized or systemic condition that results from adverse reaction to the presence of an infectious agent(s) or its toxin(s); and that was not present or incubating at the time of admission to the healthcare facility.
Healthcare-Associated Infection Advisory Committee” is a group that is appointed by the Secretary of the Department that includes one (1) infection control professional who has responsibility for infection control programs from each hospital or health care system in Delaware, four (4) infectious disease physicians with expertise in infection control, one (1) representative from the Delaware Healthcare Facilities Association, one (1) representative of a freestanding surgical center, one (1) representative of a dialysis center, one (1) representative of a psychiatric facility, and one (1) representative from the State Division of Public Health, and the Public Health Healthcare-Associated Infections Specialist responsible for collating and reporting data. The Secretary shall also appoint eight (8) other members of the Committee including representatives from direct care nursing staff, academic researchers, consumer organizations, health insurers, health maintenance organizations, organized labor and purchasers of health insurance, such as employers.
"Healthcare-Associated Infection Specialist" is a position established by the Department within the Division of Public Health supporting the functions of 16 Del.C. Ch. 10A. The Healthcare Associated Infection Specialist must have knowledge of the National Healthcare Safety Network system and skills to appropriately analyze healthcare-associated infection data.
"Healthcare Facility" means a correctional facility, dialysis center, freestanding surgical center, hospital, long-term care facility, psychiatric facility, or other facility as defined by the Centers for Medicaid and Medicare Services or the CDC.
"Hospital" means an acute care healthcare facility licensed under 16 Del.C. Ch. 10A.
Infection Preventionist (IP)” is a registered nurse, physician, epidemiologist, or medical technologist who helps to prevent healthcare-associated infections by isolating sources of infections and limiting their spread. The IP systematically collects, analyzes and interprets health data in order to plan, implement, evaluate and disseminate appropriate public health practices. The IP also trains healthcare staff through instruction and dissemination of information on infection control practices.
Long-term acute care facility (LTAC) Also referred to as a long-term care hospital by CMS. CMS defines long-term care hospitals as having an average length of stay of 25 days or more among all patients. Licensed LTACs are denoted by having the last four digits of the facility CMS Certification Number (CCN) between 2000 and 2299.
“Long-term care facility” means an institution such as a nursing home, skilled nursing facility, or intermediate care facility that provides healthcare to people who are unable to manage independently in the community.
National Healthcare Safety Network (NHSN)” means an internet-based surveillance system that is confidential. It is managed by the Division of Healthcare Quality Promotion at the CDC and used for the monitoring events associated with health care. The NHSN provides facilities and states with data needed to identify problem areas, measure progress of prevention efforts, and work toward eliminating healthcare-associated infections. It is the conduit for healthcare facilities to comply with CMS infection reporting requirements.
"Psychiatric facility" means a Facility that is primarily engaged in providing, by or under the supervision of a doctor of medicine or osteopathy, psychiatric services for the diagnosis and treatment of persons with mental illness.
Public Report” means the report provided to healthcare facilities and the public by the Department as set forth in 16 Del.C. §1003A(b).
Secretary” means the Secretary of the Department of Health and Social Services. LTACs shall collect data on healthcare-associated infections related to specific clinical procedures resulting from care in the facility as determined by CMS or the CDC and authorize the Department to have access to LTAC-specific data contained in the NHSN database consistent with the requirements of 16 Del.C. Ch. 10A. Hospitals and other healthcare facilities as specified in these regulations shall report healthcare-associated infections pursuant to to the NHSN with the exception of correctional facilities. Correctional facilities shall report healthcare-associated infections consistent with 11.3 on communicable diseases of these regulations. In making such reports, healthcare facilities shall abide by the reporting procedures required for NHSN participation, including the frequency of reports, the information to be reported, and other standards required by the NHSN.
See 16 Del.C. Ch. 31 and Department of Health and Social Services regulations promulgated thereunder, entitled "Regulations Concerning Care and Transportation of the Dead".
"Emergency medical care provider" fire fighter, law enforcement officer, paramedic, emergency medical technician, correctional officer, ambulance attendant, or other person who serves as employee or volunteer of an ambulance service and/or provides pre-hospital emergency medical service.
"Receiving medical facility" hospital or similar facility that receives a patient attended by an emergency medical care provider for the purposes of continued medical care.
"Standard precautions" those precautions, including the appropriate use of hand washing, protective barriers, and care in the use and disposal of needles and other sharp instruments, that minimize the risk of transmission of communicable diseases between patients and health care providers. Standard precautions require that all care providers use appropriate barrier precautions to prevent exposure to blood and body fluids, secretions and excretions of all patients at all times.
Last Updated: December 31 1969 19:00:00.
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