16 Del. Admin. Code § 4202-7.0

Current through Register Vol. 28, No. 7, January 1, 2025

Section 4202-7.0 - Control of Specific Contagious Diseases

7.1 Vaccine Preventable Diseases

7.1.1 All preschool children who are enrolled in a child care facility must be age-appropriately vaccinated against diseases prescribed by the Division Director.

7.1.1.1 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.

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.

7.1.2.1 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.

7.1.2.2 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 foreign exchange students, immigrants, students from other states and territories and children entering from public schools.

7.1.3 Acceptable documentation of the receipt of immunization as required by subsections 7.1.1 and 7.1.2 shall include either a medical record signed by a physician, or a valid immunization record issued by the State of Delaware or another State, which specifies the vaccine given and the date of administration.

7.1.4 Immunization requirements pursuant to subsections 7.1.1 and 7.1.2 shall be waived for:

7.1.4.1 Children whose physicians have submitted, in writing, that a specific immunizing agent would be detrimental to that child; and

7.1.4.2 Children whose parents or guardians present a notarized document that immunization is against their religious beliefs.

7.1.5 Child care facilities and private schools (grades K-12) shall maintain on file an immunization record for each child. The facility will also be responsible to report to the Division Director or designee on an annual basis the immunization status of its enrollees.

7.1.6 Parents whose children present immunization records which show that immunizations are lacking will be allowed 14 days (or such time as may be appropriate for a particular vaccination) to complete the required age-appropriate doses of vaccine for their children.

7.1.6.1 In instances where more than 14 days will be necessary to complete the age-appropriate immunization schedule, an extension may be allowed in order to obtain the required immunizations. Extension of the 14-day allowance because of missed appointments to receive needed immunizations shall not be permitted.

7.1.7 When a child's records are lost and the parent states that the child has completed the child's series of immunizations, or a child has been refused admission or continued attendance at a child care facility or private school for lack of acceptable evidence of immunization as specified in this regulation, a written certification must be provided by a health care provider who has administered the necessary age-appropriate immunizations to the child according to the current ACIP immunization schedule.

7.1.8 It is the responsibility of the child care facility or private school to exclude a child prior to admission or from continued attendance who has failed to document required immunizations pursuant to this section.

7.1.9 Upon the occurrence of a case or suspect case of one of the vaccine preventable diseases specified in pursuant to subsections 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.

7.1.9.1 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.

7.1.9.2 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, the Division Director or designee shall have the authority to close the facility until the risk of disease occurrence has passed.

7.1.10 All full-time students of post-secondary educational institutions (including post-high school institutions of education/training, such as universities, private colleges, technical and community colleges, vocational technical schools, and hospital nursing schools) and all full and part-time students in such educational institutions if engaged in patient-care related curriculums (including nursing, dentistry, and medical laboratory technology), shall be required to show evidence of immunity to measles, rubella, and mumps prior to enrollment by the following criteria:

7.1.10.1 Measles immunity:

7.1.10.1.1 Persons born before January 1, 1957; or

7.1.10.1.2 Physician documented history of measles disease; or

7.1.10.1.3 Serological confirmation of measles immunity; or

7.1.10.1.4 A documented receipt from a physician or health facility that two doses of measles vaccine were administered after 12 months of age.

7.1.10.2 Rubella immunity:

7.1.10.2.1 Persons born before January 1, 1957; except women who could become pregnant; or

7.1.10.2.2 Laboratory evidence of antibodies to rubella virus; or

7.1.10.2.3 A documented receipt from a physician or health facility that rubella vaccine was administered on or after 12 months of age.

7.1.10.3 Mumps immunity:

7.1.10.3.1 Persons born before January 1, 1957; or

7.1.10.3.2 Physician diagnosed history of mumps disease; or

7.1.10.3.3 Laboratory evidence of immunity; or

7.1.10.3.4 A documented receipt from a physician or health facility that mumps vaccine was administered on or after 12 months of age.

7.1.11 Immunization requirements pursuant to subsection 7.1.10 shall be waived for:

7.1.11.1 A student whose licensed physician certifies that such immunization may be detrimental to the student's health;

7.1.11.2 A student who presents a notarized document that immunization is against their religious beliefs.

7.1.12 The student health service, the admissions office, and the office of the university or college registrar are jointly responsible for implementing subsection 7.1.10 through notification of immunization requirements, the collection and verification of documented vaccine histories, identification and notification of students not in compliance, and imposition of sanctions for non-compliance.

7.1.13 Students who cannot show evidence of immunity to measles pursuant to subsection 7.1.10 and who cannot show documented receipt of ever having received measles vaccine shall be permitted to enroll on the condition that two doses be administered within 45 days or at the resolution of an existing medical contraindication. Students who cannot show evidence of immunity to rubella or mumps or who have had only one dose of measles vaccine shall be permitted to enroll on the condition that measles, mumps, and rubella immunizations be obtained within 14 days or at the resolution of an existing medical contraindication. However, in implementing these requirements, doses of a measles containing vaccine shall not be given closer than 28 days apart.

7.1.14 The Division Director may maintain a registry of the immunization status of persons vaccinated against any vaccine preventable diseases (hereafter called an "immunization registry").

7.1.14.1 Physicians and other health care providers who give immunizations shall report information about the immunization and the person to whom it was given for addition to the immunization registry in a manner prescribed by the Division Director or designee.

7.1.14.2 The Division Director or designee may disclose information from the immunization registry without a patient's, parent's, or guardian's written release authorizing such disclosure to the following:

7.1.14.2.1 The person immunized, or a parent or legal guardian of the person immunized, or persons delegated in writing by same.

7.1.14.2.2 Employees of public agencies or research institutions, however only when it can be shown that the intended use of the information is consistent with the purposes of Section 7.0 of this regulation.

7.1.14.2.3 Health records staff of school districts and child care facilities.

7.1.14.2.4 Persons who are other than public employees who are entrusted with the regular care of those under the care and custody of a state agency including but not limited to operators of day care facilities, group, residential care facilities and adoptive or foster parents.

7.1.14.2.5 Health insurers, however only when the person immunized is a client of the health insurer.

7.1.14.2.6 Health care professionals or their authorized employees who have been given responsibility for the care of the person immunized.

7.1.14.3 If any person authorized in subsection 7.1.14.2 discloses information from the immunization registry for any other purpose, it is an unauthorized release and such person may be subject to civil and criminal penalty.

7.2 Ophthalmia Neonatorum

7.2.1 Any physician, nurse, midwife, or other health care provider so permitted to under the law, who attends the birth of an infant in Delaware, shall provide or cause to be provided prophylactic treatment against inflammation of the eyes of the newborn.

7.2.2 Said prophylactic treatment shall be provided within 1 hour of birth and consist of:

7.2.2.1 1% silver nitrate in single dose containers;

7.2.2.2 A 1-2-centimeter ribbon of sterile ophthalmic ointment containing tetracycline (1%) or erythromycin (0.5%) in single-use tubes; or

7.2.2.3 Other treatment recommended for this purpose as published in the most recent edition of the U.S. Preventive Services Task Force, Guide to Clinical Preventive Services.

7.3 Sexually Transmitted Diseases (STDs)

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.

7.3.1.1 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 Reporting STDs

7.3.2.1 A health care provider who diagnoses, suspects, or treats a reportable STD and every administrator of a health facility or prison in which there is a case of a reportable STD shall report such case to the Division of Public Health.

7.3.2.1.1 Reports provided under this regulation shall specify the infected person's name, address, date of birth, gender, race, and ethnicity as well as the date of onset, name and stage of disease, type and amount of treatment given and the name and address of the submitting licensed health care professional.

7.3.2.2 Any person who oversees 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.

7.3.2.2.1 Reports provided under this regulation 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.

7.3.2.3 The manner and timing of reports required by subsection 7.3 shall be made in accordance with Section 2.0 of this regulation unless otherwise specified by this regulation.

7.3.2.4 All reports and notification made pursuant to this section are confidential and protected from release except under the provisions of 16 Del.C. §§ 710 and 711.

7.3.2.4.1 From information received from laboratory notifications, the Division of Public Health may contact attending physicians.

7.3.2.4.1.1 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.

7.3.2.5 Any person or facility required to report a STD under this section shall permit the Division of Public Health to examine records in order to evaluate compliance with this section.

7.4 Human Immunodeficiency Virus (HIV), Acquired Immunodeficiency Syndrome (AIDS)

7.4.1 HIV/AIDS is regarded to cause significant morbidity and mortality, can be screened, diagnosed and treated, and is of major public health concern, such that surveillance of the disease occurrence is in the public interest, and therefore shall be designated as reportable pursuant to 16 Del.C. Ch. 5. Under this provision the following shall be reported:

7.4.1.1 A diagnosis of HIV, according to the Centers for Disease Control and Prevention case definition of HIV.

7.4.1.2 A diagnosis of AIDS, according to the Centers for Disease Control and Prevention case definition of AIDS.

7.4.1.3 A positive confirmed result of any test approved and indicative of the presence of HIV.

7.4.1.4 All CD4 T-lymphocyte percentage and test results and all viral load detection test results (detectable and undetectable).

7.4.1.5 A perinatal exposure of a newborn to HIV.

7.4.2 Reporting of HIV/AIDS and perinatal exposure of newborns to HIV

7.4.2.1 A health care provider who diagnoses or treats HIV/AIDS and every administrator of a health care facility or prison in which there is an HIV/AIDS infected person or perinatal exposure to HIV shall report such information to the Division of Public Health.

7.4.2.1.1 Reports provided under this subsection shall specify the infected person's name, address, date of birth, gender, mode of transmission, race and ethnicity as well as the date of HIV positive laboratory result, date of perinatal exposure, date of AIDS diagnosis and stage of disease, type and amount of treatment given and the name and address of the submitting health care provider.

7.4.2.2 Any person who oversees 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.

7.4.2.2.1 Reports provided under this subsection 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 test results, all viral load detection test results (detectable and undetectable), and all HIV nucleotide sequencing test results. The name and address of the health care provider and that of the processing clinical laboratory shall also be included.

7.4.2.2.2 Reports made based on an HIV test to detect antibodies shall only be made if confirmed with a Western Blot or other confirmatory test.

7.4.2.2.3 All facilities obtaining blood from human donors for the purpose of transfusion or manufacture of blood products shall report HIV/AIDS consistent with subsection 7.4.2.2.

7.4.2.2.4 Any laboratory that examines specimens, or reporting source finding evidence of HIV, shall permit the Division of Public Health to examine the records of said laboratory, facility, or office in order to evaluate compliance with Section 7.0 of this regulation.

7.4.2.3 Reports made based on perinatal HIV exposure shall be made regardless of confirmatory testing.

7.4.2.4 Reports of HIV/AIDS, required by subsection 7.4 shall be placed into the United States mail, using a special envelope that will be provided by the Division of Public Health, and routed to the Division within 48 hours of diagnosis, positive test, or treatment. Any other reporting method must be approved in advance and must be in a time frame acceptable to the Division.

7.4.2.5 As it is the intent of the Division of Public Health to continue the availability of anonymous HIV counseling and testing, and as it is not the practice to collect the name or other identifying information from a person who is anonymously tested for HIV, and therefore no name is available to be reported, nothing in this regulation shall preclude the performance of anonymous HIV testing.

7.4.3 Confidentiality of HIV/AIDS Reports

7.4.3.1 The Division of Public Health will evaluate reports of HIV/AIDS for completeness and potential referrals for service. All case reports will be kept in a confidential and in a secure setting.

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.

7.4.3.3 The Division of Public Health will follow the December 10, 1999 Morbidity and Mortality Weekly Report Recommendations and Reports, "CDC Guidelines for National Human Immunodeficiency Virus Case Surveillance, Including Monitoring for Human Immunodeficiency Virus Infection and Acquired Immunodeficiency Syndrome" document as it pertains to patient records and confidentiality, or any subsequent revisions of said document.

7.4.3.4 All reports and notification made pursuant to Section 7.0 of this regulation are confidential and protected from release except under the provisions of 16 Del.C. §§ 710 and 711, §§ 1201 through 1204, and §§ 1201A through 1204A. 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:

7.4.3.4.1 Against any person who negligently violates a provision of this regulation, damages of $1,000 or actual damages, whichever is greater.

7.4.3.4.2 Against any person who intentionally or recklessly violates a provision of subsection 7.4 of this regulation, damages of $5,000 or actual damages, whichever is greater.

7.4.3.4.3 Reasonable attorneys' fees.

7.4.3.4.4 Such other relief, including an injunction, as the court may deem appropriate.

7.4.3.4.5 Any action under this regulation is barred unless the action is commenced within three years after the cause of action accrues. A cause of action will accrue when the injured party becomes aware of an unauthorized disclosure.

7.4.3.5 From information received from reports of HIV infection, the Division of Public Health may contact attending physicians.

7.4.3.5.1 The Division of Public Health shall inform the attending physician, if the notification indicates the person has an attending physician, before contacting a person on whom the report is made. However, if delays resulting from informing the physician may enhance the spread of HIV, or otherwise endanger the health of any individuals, the Division of Public Health may contact the person without first informing the attending physician.

7.4.4 Duty to Disclose the Identity of Sexual or Needle sharing Partners of HIV Infected Patients

7.4.4.1 Any health care provider diagnosing or caring for an HIV infected patient shall disclose the identity of the patient's sexual or needle-sharing partner or partners (if known), including spouses to the Division of Public Health so that the partner or partners may be notified of their risk of infection, provided that:

7.4.4.1.1 The provider knows of an identifiable partner at risk of infection who may not have been informed of their potential risk; and

7.4.4.1.2 The provider believes there is a significant risk of harm to the partner; and

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 unlikely to notify the partner.

7.4.4.2 Any health care provider diagnosing or caring for an HIV infected patient shall also report to the Division of Public Health relevant facts about a patient that does not pose a threat to an identifiable partner but, in the professional judgment of the provider based upon stated intended acts, the patient may threaten further spread of HIV to the general population. In this instance the conditions specified in subsection 7.4.4.1.3 shall apply. Disclosure shall be for the purpose of providing appropriate counseling to the patient.

7.4.4.3 Procedures for disclosing information pursuant to this section shall be specified by the Division.

7.5 Tuberculosis

7.5.1 Any person afflicted with or suspected of being afflicted with tuberculosis disease and in need of hospitalization and unable to pay the cost, shall be hospitalized at public expense wherever and whenever facilities are available and provided that private or third-party funds are not available for this purpose.

7.5.2 Reporting Tuberculosis

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.

7.5.2.1.1 Reports provided under this subsection shall specify 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.

7.5.2.1.2 A report shall be telephoned into the Division of Public Health within two working days of the provision of service or laboratory finding.

7.5.2.2 Any person who oversees a clinical or hospital laboratory or other facility in which a laboratory examination of sputa, gastric contents, or any other specimen derived from human body yields microscopic, cultural, serological, or other evidence suggestive of tubercle bacilli shall notify the Division of Public Health by telephone within two working days of the occurrence.

7.5.2.3 Any health care provider who has knowledge about a person with multiple drug-resistant tuberculosis (MDR-TB), even if the confirmed or suspected TB cases had been previously reported, shall report the occurrence to the Division of Public Health within two days of the occurrence.

7.5.2.4 Persons with TB who have demonstrated an inability or an unwillingness to adhere to a prescribed treatment regimen, who refuse medication, or who show other evidence of not taking anti-TB medications as prescribed, shall be reported to the Division of Public Health within two days of the occurrence.

7.5.3 Diagnostic Examinations

7.5.3.1 Any persons suspected of having infectious tuberculosis shall have a tuberculosis skin or blood test, a chest radiograph, laboratory examination 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.

7.5.3.2 The Division Director or designee shall determine the names of household and other contacts who may be infected with tuberculosis and cause them to be examined for the presence of tuberculosis disease.

7.5.4 Clinical Management

7.5.4.1 In addition to fulfilling the reporting requirements of subsection 7.5.2, health care providers shall manage persons with active TB disease by following one of three courses of action:

7.5.4.1.1 They shall immediately refer the client to the Division of Public Health for comprehensive medical and case management services; or

7.5.4.1.2 They shall provide comprehensive assessment, treatment, and follow-up services (including patient education, directly observed therapy and contact investigation) to the client and the client's contacts consistent with current American Thoracic Society and the Centers for Disease Control and Prevention (ATS/CDC) guidelines; or

7.5.4.1.3 They shall initiate appropriate medical treatment and refer the client to the Division of Public Health for coordination of community services and case management including directly observed therapy (DOT).

7.5.4.1.3.1 If the health care provider chooses subsection 7.5.4.1.2 or 7.5.4.1.3 above, then the Division Director or designee may ask the health care provider for information about the care and management of the patient, and the health care provider shall assure that the requested information is communicated.

7.5.4.2 Patients with infectious tuberculosis who are dangerous to public health may be required by the Division Director or designee to be hospitalized, isolated, or otherwise quarantined. Whenever facilities for adequate isolation and treatment of infectious cases are available in the home and patient will accept said isolation, it shall be left to the discretion of the Division Director or designee as to whether these or other facilities shall be used.

7.6 Healthcare-Associated Infections. By January 1, 2008, 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.

7.6.1 Definitions

For the purpose of Section 7.0 of this regulation, the following definitions shall apply:

"Agency for Healthcare Research and Quality" or "AHRQ" means 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.

United States-Department of Health and Human Services public health safety

"Centers for Medicaid and Medicare Services" or "CMS" means 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 Delaware 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 the 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" or "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" or "HAI" means a localized or systemic condition that results from adverse reaction to the presence of an infectious agent or agents or its toxins; and that was not present or incubating at the time of admission to the healthcare facility.

"Healthcare-Associated Infection Advisory Committee" means a group that is appointed by the Secretary of the Department that includes 1 infection control professional who has responsibility for infection control programs from each hospital or health care system in Delaware, 4 infectious disease physicians with expertise in infection control, 1 representative from the Delaware Healthcare Facilities Association, 1 representative of a freestanding surgical center, 1 representative of a dialysis center, 1 representative of a psychiatric facility, and 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 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" means 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" or "IP" means a registered nurse, physician, epidemiologist, or medical technologist who helps to prevent healthcare-associated infections by isolating source or 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" or "LTAC" means a long-term care hospital as defined 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" or "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 Delaware Department of Health and Social Services.

7.6.2 Membership in NHSN

7.6.2.1 All hospitals in the State shall join the NHSN or its successor.

7.6.2.2 All outpatient dialysis centers in the State shall join the NHSN or its successor in accordance with CMS reporting specifications.

7.6.2.3 All LTACs in the State shall join the NHSN or its successor in accordance with CMS reporting specifications.

7.6.2.3.1 Every licensed LTAC (denoted by having the last four digits of the facility CMS Certification Number (CCN) between 2000 and 2299) shall join the NHSN as an individual LTAC facility with a unique NHSN facility ID number.

7.6.2.3.2 If an independently licensed LTAC location currently resides within an acute care or critical access facility type within NHSN, that LTAC location must be removed from the hospital and enrolled in NHSN as a separate facility and identified as a "HOSP-LTAC" facility type.

7.6.2.4 With concurrence of the HAI Advisory Committee, the Department may require other healthcare facilities through regulation to join the NHSN as may be appropriate in accordance with 16 Del.C. Ch 10A.

7.6.3 Persons and Institutions Required to Report

7.6.3.1 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 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.

7.6.3.2.1 Hospital staff assigned to fulfill the obligations of reporting under this regulation shall be trained and shall follow the methods and procedures required by the NHSN as a condition of participation.

7.6.3.3 Correctional facilities shall report data on any healthcare-associated infections 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 Outpatient dialysis centers shall 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.

7.6.3.4.1 Outpatient dialysis center staff assigned to fulfill the obligations of reporting under this regulation shall be trained and shall follow the methods and procedures required by the NHSN as a condition of participation.

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.

7.6.3.5.1 LTAC staff assigned to fulfill the obligations of reporting under this regulation shall be trained and shall follow the methods and procedures required by the NHSN as a condition of participation.

7.6.3.6 Other healthcare facilities required to join the NHSN, as determined by the HAI Advisory Committee, shall authorize the Department to have access to healthcare facility-specific data contained in the NHSN database consistent with the requirements of 16 Del.C. Ch. 10A.

7.6.3.6.1 Staff of other healthcare facilities required to join the NHSN as determined by the HAI Advisory Committee that are assigned to fulfill the obligations of reporting under this regulation shall be trained and shall follow the methods and procedures required by the NHSN as a condition of participation.

7.6.4 Reporting of Data

7.6.4.1 Healthcare-associated infections required to be reported to the Department shall consist of the same HAIs required to be reported to 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 Hospitals and other healthcare facilities as specified in this regulation shall report healthcare-associated infections pursuant to subsection 7.6.4.1 to the NHSN except for correctional facilities.

7.6.4.3 Correctional facilities shall report healthcare-associated infections consistent with subsection 11.3 on communicable diseases of this regulation.

7.6.4.4 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.

7.6.5 Hospital reports

7.6.5.1 Individual hospitals shall report to the Department those healthcare-associated infections required by CMS to be reported.

7.6.5.2 Infection preventionists, or a designee, of hospitals shall submit quarterly reports on their healthcare-associated infection data to the Department using the accepted NHSN definitions. Prevention and control data related to quality measures will be based on nationally recognized and recommended standards that may include those developed by the CDC, CMS, or the AHRQ.

7.6.6 Correctional facility reports

7.6.6.1 Correctional facilities shall report data on any healthcare-associated infections related to specific clinical procedures resulting from care in the correctional facility's medical unit. These categories of infection data may differ from that information required from hospitals.

7.6.6.2 A designee of the correctional facility shall submit quarterly reports on their healthcare-associated infection data to the Department using the accepted CDC, NHSN, or Department definitions. Prevention and control data related to quality measures will be based on nationally recognized and recommended standards that may include those developed by the CDC, CMS, or the AHRQ. The information from the correctional facilities shall be segregated from the hospital data contained in the reports submitted pursuant to 16 Del.C. Ch. 10A.

7.6.7 Outpatient dialysis center reports

7.6.7.1 Individual outpatient dialysis centers shall report to the Department those healthcare-associated infections required by CMS to be reported.

7.6.7.2 Infection preventionists, or a designee, of outpatient dialysis centers shall submit quarterly reports on their healthcare-associated infection data to the Department using the accepted NHSN definitions. Prevention and control data related to quality measures will be based on nationally recognized and recommended standards that may include those developed by the CDC, CMS, or the AHRQ.

7.6.8 Other healthcare facility reports

7.6.8.1 Only with the concurrence of the HAI Advisory Committee, and not until such time that CMS or CDC issue final federal regulations requiring such, and after careful evaluation of the economic and public health impact, the Department may through regulation require the reporting of healthcare-associated infections from healthcare facilities other than hospitals, correctional facilities, LTACs, and outpatient dialysis centers.

7.6.8.2 The procedures for reporting shall be consistent with procedures for reporting by hospitals as specified in this chapter, except as may be necessary to accommodate the unique characteristics and capabilities of the healthcare facilities and the capabilities of the NHSN.

7.6.9 Quarterly Reports

7.6.9.1 The Department will collate and prepare healthcare-associated infection data reported in NHSN by healthcare facilities quarterly and make these quarterly reports publicly available.

7.6.9.2 Data in quarterly reports must cover a period ending not earlier than 45 days prior to submission of the report.

7.6.9.3 Quarterly reports shall be made available to each healthcare facility 45 days after submittal to the Department for review by the healthcare facilities.

7.6.9.4 The healthcare facilities shall have seven days to review the quarterly reports and report any changes to the Department. Following the seven-day review period, such quarterly reports shall be made available to the public at each hospital and through the Department (the "Public Report").

7.6.9.5 If the healthcare facility is a hospital that 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 or subsidiary and not for the other entity.

7.6.9.6 After June 30, 2010, and upon consultation with the HAI Advisory Committee and other experts in infection, prevention, identification and control, the Department may revise categories of infections set forth in subsection 7.6.4.1.

7.6.10 Annual Department reports

7.6.10.1 The Department shall annually submit to the legislature a report summarizing the hospital quarterly reports and shall publish the annual report on its website. Following the initial report, the Department shall update the public information on a quarterly basis.

7.6.10.2 All reports issued by the Department shall be risk adjusted or use some other method to account for the differences in patient populations among hospitals.

7.6.10.3 The annual report shall compare healthcare-associated infection rates to national rates (i.e. the use of standardized infection ratios [SIRs]) published by the NHSN program and collected pursuant to this chapter for each individual hospital in the State. The Department, in consultation with the HAI Advisory Committee, shall make this report as easy to comprehend as possible. The report shall also include an executive summary, written in plain language that shall include a discussion of findings, conclusions, and trends concerning the overall state of healthcare-associated infections in the State, including a comparison to prior years. The report may include policy recommendations, as appropriate.

7.6.10.4 The Department shall publicize the report and its availability as widely as practical to interested parties, including hospitals, providers, media organizations, health insurers, health maintenance organizations, purchasers of health insurance, organized labor, consumer or patient advocacy groups and individual consumers. The annual report shall be made available to any person upon request.

7.6.10.5 No healthcare facility report or Department disclosure may contain information identifying a patient, employee, or licensed health care professional in connection with a specific infection incident, pursuant to 16 Del.C. Ch. 10A.

7.6.10.6 The annual report shall provide background information about each hospital, which shall include: the hospital's adult and pediatric populations, bed size, and specialty divisions, whether the hospital provides tertiary care, and whether the hospital is a teaching or nonteaching institution. This background information shall be included in the Public Report.

7.6.10.7 The annual report shall include a brief summary to allow hospitals to comment on performance improvement and changes in patient population and risk factors. The information contained in the summary report shall be considered proprietary information and shall be utilized by the Department but shall not be made available in the Public Report and shall not be subject to disclosure under the State's Freedom of Information Act [29 Del.C. Ch. 100].

7.6.11 Healthcare-Associated Infection Advisory Committee

7.6.11.1 The HAI Advisory Committee engages personnel with appropriate training or certification in infection prevention and control for the purposes of collecting data.

7.6.11.2 The HAI Advisory Committee shall assist the Department in the development of all aspects of the Department's methodology for collection, analyzing, and disclosing the information collected under 16 Del.C. Ch. 10A including collection methods, formatting, and methods and means for release and dissemination.

7.6.11.3 In developing the methodology for collecting and analyzing the infection rate data, the Department and the HAI Advisory Committee shall adopt the methodologies and system for data collection from the NHSN or its successor. The data collection and analysis methodology shall be disclosed to the public prior to any public disclosure of healthcare-associated infection rates.

7.6.11.4 The HAI Advisory Committee shall assist the Department in the sharing of information and best practices toward the development of activities and policies that:

7.6.11.4.1 Enhance coordination between healthcare facilities throughout the continuum of care for the prevention and control of healthcare-associated infections;

7.6.11.4.2 Promote the prevention and control of healthcare-associated infections generally; and

7.6.11.4.3 Encourage the creation of benchmarks against which to measure progress in the prevention and control of healthcare-associated infections.

7.6.12 Privacy. It is the express intent of the legislature that a patient's right of confidentiality shall not be violated in any manner. Patient Social Security numbers and any other information that could be used to identify an individual patient shall not be released notwithstanding any other provision of law.

7.6.13 Penalties

7.6.13.1 A determination that a healthcare facility has violated the provisions of this chapter may result in any of the following:

7.6.13.1.1 Termination of licensure or other sanctions relating to licensure under Chapter 10 of this title; or

7.6.13.1.2 A civil penalty of up to $500 per day per violation for each day the healthcare facility is in violation of 16 Del.C. Ch. 10A.

7.6.14 Regulatory oversight. The Department shall be responsible for ensuring compliance. When the Department licenses a healthcare facility according to the provisions of this title, compliance with this chapter shall be a condition of licensure.

7.6.15 Privilege and confidentiality protections. Notwithstanding any other provision of federal, state, or local law, the healthcare-associated infection data provided pursuant to this chapter is privileged and, except for §§1003A, 1004A and 1005A of 16 Del.C. Ch. 10A., shall not be:

7.6.15.1 Subject to admission as evidence or other disclosure in any federal, state, or local civil, criminal, or administrative proceeding; or

7.6.15.2 Subject to use in a disciplinary proceeding against a healthcare facility or provider; or

7.6.15.3 Subject to disclosure under 29 Del.C. Ch. 100.

16 Del. Admin. Code § 4202-7.0

9 DE Reg. 1188 (02/01/06)
12 DE Reg. 1418 (05/01/09)
15 DE Reg. 1163 (02/01/12)
17 DE Reg. 320 (9/1/2013)
22 DE Reg. 1012 (6/1/2019)
23 DE Reg. 665 (2/1/2020)
24 DE Reg. 791 (2/1/2021)
27 DE Reg. 863 (5/1/2024) (Final)