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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsJune 2013

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Statutory Authority: 16 Delaware Code, Section 122(3)a (16 Del.C. §122(3))
16 DE Admin. Code 4202
Copies of the proposed regulations are available for review in the June 1, 2013 edition of the Delaware Register of Regulations, accessible online at: http://regulations.delaware.gov or by calling the Bureau of Epidemiology, Division of Public Health, at (302) 744-1033.
"Carrier" 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" A person whose body has been invaded by an infectious agent with the result that clinical symptoms have occurred.
"Child Care Facility" 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" means see “Contagious Disease”.
"Contact" A person or animal that has been in such association with an infected person or animal or a contaminated environment as to have had opportunity to acquire exposure to the infection.
"Contagious Disease" - An infectious disease that can be transmitted from person to person, or animal to person.
Designee The person named by the Director of the Division of Public Health to assume a specific responsibility.
"Division" - The Division of Public Health.
Division Director The Director of the Division of Public Health.
Directly Observed Therapy (DOT) an adherence-enhancing strategy in which a health care worker or other designated person watches observes the patient swallow each dose of medication to ensure each dose of medication is swallowed.
"Epidemic" or "Outbreak" 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" 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 InfectionThe presence of repeatedly reactive screening tests for HIV antibody (for example, enzyme immunoassay) with specific antibody identified by the use of supplemental tests such as Western Blot or immunofluorescence assay; or direct identification of virus in host tissues by virus isolation (for example, culture); or HIV antigen detection (for example p24 antigen); or a positive result on any other highly specific licensed test for HIV in accord with the Centers for Disease Control and Prevention case definition of HIV and DPH Laboratory endorsed diagnostic protocols.
"Infectious disease" 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" 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 to non-isolated individuals.
"Medical Examiner" 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" 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" 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" A written, electronic, or verbal report as required by any section of these Rules.
"Outbreak" - Refer to definition of "Epidemic".
Post-Secondary Institution Means and iIncludes state 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:
And, which Pposes a high probability of any of the following harms:
"Quarantine" 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 and 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 to non-quarantined individuals.
Resistant Organism 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 Multi-Drug Resistant Organism.
"Sensitive Situation" 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" The person, animal, object or substance from which an infectious agent passes directly to the host.
"Suspect" 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" - 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, telephonically 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.
2.2.2 Except as otherwise provided by these regulations, reports of notifiable or other diseases or conditions required to be reported by these regulations shall contain sufficient information to contact the person reporting. When available, the following information shall be reported: the name, address, telephone number, date of birth, race, ethnicity, gender, and disease of the person ill or infected, the date of onset of illness; the name, address, and telephone number of the person's health care provider; and any pertinent laboratory information.
4.3.1.2 A suspected agent of bioterrorism immediately upon when receipt of the results. were obtained
4.3.3 Reporting of antibiotic resistant organisms. Any person in charge of a clinical or hospital laboratory, or other facility in which a laboratory examination of any specimen derived from a human body and submitted for microbiologic examination yields a non-susceptible species of microorganism identified in Appendix I by (A), will report the infected person's name, address, date of birth, race, ethnicity, sex, site of isolation, date of isolation and MIC/Zone diameter to the Division of Public Health. Upon request, the Division may waive the requirement for the reporting of said demographic information until such time that electronic reporting facilitates its reporting. In addition, the number of susceptible and non-susceptible isolates of any of these organisms shall be reported monthly to the Division of Public Health.
6.7.1.3 The date and time at which the Division requests isolation or quarantine to commence;
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.
7.1.2 Any child entering private school must be age-appropriately vaccinated against diseases prescribed by the Division Director, prior to enrolling in school. For those diseases so prescribed, the most current recommendations of the federal Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices' (ACIP) shall determine the vaccines and vaccination schedules acceptable for compliance with this regulation. This provision pertains to all children between the ages of 2 months and 21 years entering or being admitted to a Delaware private school for the first time including, but not limited to, foreign exchange students, immigrants, students from other states and territories and children entering from public schools.
7.1.9 Upon the occurrence of a case or suspect case of one of the vaccine preventable diseases specified in pursuant to sections 7.1.1 and 7.1.2, any child not immunized against that disease shall be excluded from the premises, until the Division Director or designee has determined that the disease risk to the unimmunized child has passed. Such exclusion shall apply to all those in the facility who are admitted under either medical or religious exemption as well as to those previously admitted who have not yet received vaccine against the disease which has occurred. If, in the judgment of the Division Director or designee, the continued operation of the facility presents a risk of the spread of disease to the public at large, he/she shall have the authority to close the facility until the risk of disease occurrence has passed.
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.
7.3.2.2 Any person who is in charge of a clinical or hospital laboratory, blood bank, mobile unit, or other facility in which a laboratory examination of any specimen derived from a human body yields microscopic, cultural, serological, or other evidence suggestive of a reportable STD shall notify the Division of Public Health. Reports provided under this rule shall specify the name, date of birth, race, ethnicity, gender and address of the person from whom the specimen was obtained, laboratory findings, and the name and address of the physician and that of the processing clinical laboratory. Identifying and demographic information shall be required only if made known to the reporting laboratory or hospital in which the laboratory is part.
7.3.2.4 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.
7.4.2.2 Any person who is in charge of a clinical or hospital laboratory, blood bank, mobile unit, or other facility in which a laboratory examination of any specimen derived from a human body yields serological or other evidence of HIV/AIDS, including perinatal exposure to HIV, shall notify the Division of Public Health. Reports provided under this rule shall specify the name, date of birth, race, ethnicity, gender and address of the person from whom the specimen was obtained, laboratory findings, including all CD4 T-lymphocyte percentage and test results and all viral load detection test results (detectable and undetectable), and the name and address of the health care provider and that of the processing clinical laboratory.
7.4.3.2 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.
7.4.3.4 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:
7.4.4.1.3 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.
7.5.2.1 Physicians, pharmacists, nurses, hospital administrators, medical examiners, morticians, laboratory administrators, and other health care providers who provide health care services to a person with diagnosed, suspected or treated tuberculosis (TB) shall report such a case to the Division of Public Health specifying the infected person's name, address, date of birth, race, ethnicity, gender, date of onset, site of disease, prescribed anti-TB medications, and, in the case of laboratory administrators, the name and address of the submitting health professional. A report shall be telephoned into the Division of Public Health within two working days of the provision of service or laboratory finding.
7.5.3.1 Any persons suspected of having infectious tuberculosis shall have a Mantoux tuberculin tuberculosis skin or blood test, a chest radiograph, and laboratory examinations of sputum, gastric contents or other body discharges as may be required by the Division Director or designee to determine whether said patient represents an infectious case of tuberculosis.
7.6 Hospital Acquired Healthcare-Associated Infections
By January 1, 2008, hospital acquired healthcare-associated infections shall be reported to the Centers for Disease Control and Prevention (CDC) through the National Healthcare Safety Network (NHSN) in accordance with the NHSN and the Department of Health and Social Service requirements and procedures as cited in 16 Del.C. Ch. 10A.
"Agency for Healthcare Research and Quality (AHRQ)" 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)” An agency of the United States Department of Health and Human Services which 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 focuses national attention on developing and applying disease prevention and control (especially infectious diseases) recommendations for chronic and infectious diseases, environmental health, occupational safety and health, health promotion, prevention and education activities designed to improve the health of the people of the United States.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) 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” Any health care facility medical unit operated at within any Department of Correction facility in this State.
Department” The Department of Health and Social Services.
Dialysis center 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) 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, or; (2) a facility that provides services and/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 except when it holds itself out to the public or other health care providers as an FSSC or similar facility, or; it is operated or used by a person or entity different than the physician(s), or; patients are charged a fee for use of the facility in addition to the physician’s professional services.
Hospital Acquired Healthcare-Associated Infection (HAI)” 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 hospital or the correctional healthcare facility.
Hospital Acquired Healthcare-Associated Infection Advisory Committee” 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 Hospital Healthcare-Associated Infections Specialist responsible for collating and reporting data. The Secretary shall also appoint seven (7) 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" 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" A correctional facility, dialysis center, freestanding surgical center, hospital, long-term care facility, psychiatric facility, or other facilities as defined by the Centers for Medicaid and Medicare Services or the CDC.
"Hospital" An acute care healthcare facility licensed under 16 Del.C. Ch. 10A.
Infection Control Practitioner Preventionist (ICP)” A registered nurse, physician, epidemiologist, or medical technologist who helps to prevent healthcare-acquired associated infections by isolating sources of infections and limiting their spread. The ICP systematically collects, analyzes and interprets health data in order to plan, implement, evaluate and disseminate appropriate public health practices. The ICP 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” Institutions such as nursing homes, skilled nursing facilities, or intermediate care facility that provide healthcare to people who are unable to manage independently in the community.
National Healthcare Safety Network (NHSN)” 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. It provides risk adjusted data to the participating facilities to analyze in order to recognize trends. Its initial focus is on infections in patients and healthcare personnel. There are plans to expand NHSN to include noninfectious events (such as process measures). 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" 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 mentally ill persons.
Public Report” the report provided to the hospitals, correctional healthcare facilities and the public by the Department as set forth in 16 Del.C. §1003A(b).
Secretary” The Secretary of the Department of Health and Social Services
7.6.2.1 All hospitals in the State shall join the CDC’s NHSN or its successor. If the NHSN is not open for enrollment to all hospitals by this date December 31, 2007, all hospitals shall join the NHSN within 180 days after the CDC permits such enrollment.
7.6.2.2 Hospitals shall confer rights to the Department to have access to hospital-specific data contained in the NHSN database consistent with the requirements of 16 Del.C. Ch. 10A. All outpatient dialysis centers in the State shall join the CDC’s NHSN or its successor in accordance with CMS reporting specifications.
7.6.2.3 Hospital staff assigned to fulfill the obligations of reporting under these regulations shall be trained and shall follow the methods and procedures required by the NHSN as a condition of participation. All LTACs in the State shall join the CDC’s NHSN or its successor in accordance with CMS reporting specifications.
7.6.3.1 Physicians, who perform a clinical procedure, shall report to the ICP of the hospital where the clinical procedure was performed any hospital-acquired infection that the physician diagnosed at a follow-up appointment with the patient. A physician who diagnoses and treats a healthcare-associated infection related to a clinical procedure, or a licensed practitioner who is permitted by law to diagnose and treat such infection and does so, is required to report the infection back to the healthcare facility at which the clinical procedure was performed. The infection control department of the healthcare facility will then be required to report to the Department only those infections that meet the accepted NHSN definitions and are currently required to be reported by law.
7.6.3.2 The hospital’s reporting officer or his or her designee shall submit monthly data on his or her hospital acquired infection rates to the Department through the NHSN, using the accepted CDC’s NHSN definitions. Hospitals shall report data on healthcare-associated infections and authorize the Department to have access to hospital-specific data contained in the NHSN database consistent with the requirements of 16 Del.C. Ch. 10A.
7.6.3.3 Correctional facilities shall collect report data on hospital acquired any healthcare-associated infections and infections in the correctional health care facilities as determined by the Hospital Acquired Infection Advisory Committee and promulgated by the Department. They shall report this data to the Department on a monthly basis related to specific clinical procedures resulting from care in the correctional facility’s medical unit consistent with the requirements of 16 Del.C. Ch. 10A.
7.6.3.4 If the hospital is a division or subsidiary of another entity that owns or operates other hospitals or related organizations, the quarterly report shall be for the specific division of subsidiary and not for the other entity. Outpatient dialysis centers shall collect report 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 outpatient dialysis center-specific data contained in the NHSN database consistent with the requirements of 16 Del.C. Ch. 10A.
7.6.3.5 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.
7.6.4.1 Hospital-acquired Healthcare-associated infections required to be reported to the Department shall consist of the same HAIs required to be reported to the Centers for Medicare and Medicaid Services (CMS). In carrying out this requirement hospitals shall comply with the Hospital Inpatient Prospective Payment System final rule as published by CMS in the Federal Register.
7.6.4.2 Other hospital-acquired infection rates shall be updated by the order of the Department per determination by the Hospital Acquired Infection Advisory Committee.
7.6.4.3 Hospitals and other healthcare facilities as specified in these regulations shall report hospital acquired healthcare-associated infections pursuant to 7.6.4.1 and 7.6.4.2 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, hospitals 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 blood, body fluids, secretions, and excretions of care providers use appropriate barrier precautions to prevent exposure to blood and body fluids, secretions and excretions of all patients at all times.
11.2.1 Didactic Instruction. Education and training with respect to universal standard precautions shall be a mandatory component of any required training and any required continuing education for all emergency medical care providers who have patient contact. Training shall be appropriately tailored to the needs and educational background of the person(s) being trained. Training shall include, but not be limited to, the following:
Influenza Associated Infant Mortality (T)
Meningococcal Infections, all types invasive only (T)
5. The following isolates and/or clinical specimens from humans shall be sent to the Delaware Public Health Laboratory for testing within 24 hours of identification:
Streptococcus pneumoniae, sterile sites, Penicillin resistant
Staphylococcus aureus, Vancomycin intermediate or resistant (VISA, VRSA)
Last Updated: December 31 1969 19:00:00.
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