44:22:01:01.  Definitions. Terms used in this article mean:

 

          (1)  "Abstract," a summary from the medical record of pertinent cancer information about the patient, the disease, the cancer-directed treatment, and the disease process from the time of diagnosis until the patient's death;

 

          (2)  "Cancer," includes:

 

               (a)  Any malignant and in situ neoplasm of any site, excluding any basal and squamous cell carcinoma of the skin;

               (b)  Any basal and squamous cell carcinoma of any mucoepidermoid site; and

               (c)  Any brain and central nervous system neoplasm regardless of malignancy;

 

          (3)  "Central cancer registry," "SDCR," the South Dakota Cancer Registry, the central database of cancer cases in South Dakota maintained by the department;

 

          (4)  "Department," the South Dakota Department of Health;

 

          (5)  "Disease index," a listing of patients from a reporting entity organized by a disease or diagnosis code;

 

          (6)  "Free-standing radiology center," a radiology center operating independently of a hospital system;

 

          (7)  "Hospital," an establishment licensed pursuant to SDCL chapter 34-12;

 

          (8)  "NAACCR," the North American Association of Central Cancer Registries;

 

          (9)  "NPCR," the National Program of Cancer Registries;

 

          (10)  "Nurse midwife," a person licensed pursuant to SDCL chapter 36-9A;

 

          (11)  "Nurse practitioner," a person licensed pursuant to SDCL chapter 36-9A;

 

          (12)  "Pathology laboratory," a health care facility responsible for the microscopic analysis of tissues and body fluids;

 

          (13)  "Physician," a person licensed pursuant to SDCL chapter 36-4;

 

          (14)  "Physician assistant," a person licensed pursuant to SDCL chapter 36-4A;

 

          (15)  "Primary cancer site," the site where a cancer originates;

 

          (16)  "Record," any section of a patient's health information file that is needed for a complete cancer abstract;

 

          (17)  "Research," any systematic investigation designed to answer a defined scientific question that requires collection and analysis of data in order to develop or contribute to generalizable knowledge;

 

          (18)  "Researcher," the primary investigator or project director of a study; and

 

          (19)  "Tumor registry," a data collection management system with complete cancer abstracts in a NAACCR layout.

 

          Source: 18 SDR 142, effective March 9, 1992; 29 SDR 21, effective August 27, 2002; 32 SDR 69, effective November 7, 2005.

          General Authority: SDCL 1-43-13.

          Law Implemented: SDCL 1-43-11, 1-43-13.

 

          44:22:01:02.  Organization and structure. The department is the custodian of the central cancer registry and is responsible for the overall collection, validation, analysis, and dissemination of data and information related to the system. The department may enter into agreements or contracts with other public or private entities in performing these functions.

 

          Source: 18 SDR 142, effective March 9, 1992; 29 SDR 21, effective August 27, 2002; 32 SDR 69, effective November 7, 2005.

          General Authority: SDCL 1-43-13.

          Law Implemented: SDCL 1-43-12, 1-43-13.

 

          44:22:01:03.  Functions of central cancer registry. The central cancer registry is a surveillance system and shall be used to:

 

          (1)  Monitor the incidence and mortality of cancer in the state to detect potential public health problems;

 

          (2)  Inform and educate by providing descriptive data on cancer incidence and mortality to health professionals and the general public about risks, prevention, and early detection of cancers known to be elevated in their communities;

 

          (3)  Guide decisions about how to use public-funded cancer control resources by more accurately targeting intervention resources for communities and patients and their families; and

 

          (4)  Respond to public concerns.

 

          Source: 18 SDR 142, effective March 9, 1992; 29 SDR 21, effective August 27, 2002; 32 SDR 69, effective November 7, 2005.

          General Authority: SDCL 1-43-13.

          Law Implemented: SDCL 1-43-11, 1-43-13.

 

          44:22:02:01.  Entities required to provide report. Any hospital, physician, physician assistant, nurse practitioner, or nurse midwife, pathology laboratory, or free-standing radiology center that detects, diagnoses, or treats a cancer case in South Dakota shall submit the information needed on a cancer case to the department or its representative as required by §§ 1-43-11 to 1-43-17, inclusive.

 

          A federal tumor registry may participate in the central cancer registry if the registry submits reports in conformance with the same standards. Any other entity may voluntarily submit any cancer case to the central cancer registry.

 

          Source: 18 SDR 142, effective March 9, 1992; 29 SDR 21, effective August 27, 2002; 32 SDR 69, effective November 7, 2005.

          General Authority: SDCL 1-43-13.

          Law Implemented: SDCL 1-43-13, 1-43-15.

 

          44:22:02:02.  Reportable conditions -- General criteria. The following conditions are reportable:

 

          (1)  Any neoplasm listed in the International Classification of Diseases for Oncology, Third Edition, 2000, with a behavior code of "2", in situ, or "3", malignant, with the exception of:

 

               (a)  Carcinoma in situ of the cervix;

               (b)  Intraepithelial neoplasia of the cervix (CIN) and prostate (PIN); and

               (c)  Basal or squamous cell carcinoma of the non-mucoepidermoid sites of the skin (C44.0-C44.9):

 

                      (i)    8000-8005 Neoplasms malignant (NOS) (C44.0-C44.9);

                      (ii)   8000-8046 Epithelial carcinomas of the skin (C44.0-44.9);

                      (iii)  8050-8084 Papillary and squamous cell carcinomas of the skin (C44.0-C44.9); and

                      (iv)  8090-8110 Basal cell carcinomas of the skin (C44.0-C44.9);

 

          (2)  Any basal and squamous cell carcinoma originating in mucoepidermoid sites: such as the lips (C00.0-C00.9), anus (C21.0), vagina (C52.9), clitoris, labia, vulva (C51.0-C51.9), scrotum (C63.2), or penis (C60.0-C60.9);

 

          (3)  Any vulvar (VIN III), vaginal (VAIN III), and anal (AIN III) intraepithelial neoplasia;

 

          (4)  Any brain and central nervous system tumor, benign or malignant; or

 

          (5)  Any tumor that is not histologically confirmed but with any record that contains any of the following words:

 

apparently	favor	probable	typical of
appears to	favors	suspect
comparable with	malignant appearing	suspected
compatible with	most likely	suspicious
consistent with	presumed	suspicious for

 

          However, if the record contains the word "suspicious" and there is no positive biopsy or physician's clinical impression to support the cytology findings, the condition is not reportable.

 

          Source: 18 SDR 142, effective March 9, 1992; 29 SDR 21, effective August 27, 2002; 32 SDR 69, effective November 7, 2005.

          General Authority: SDCL 1-43-13.

          Law Implemented: SDCL 1-43-11, 1-43-13.

 

          Reference: International Classification of Diseases for Oncology, Third Edition, 2000, World Health Organization. Copies may be obtained from the World Health Organization Publications Center, USDA, 49 Sheridan Avenue, Albany, NY 12210. Cost: $54.

 

          44:22:02:05.  Standards for determining single and multiple primary tumors. Repealed.

 

          Source: 18 SDR 142, effective March 9, 1992; 29 SDR 21, effective August 27, 2002; repealed, 32 SDR 69, effective November 7, 2005.

 

          44:22:02:06.  Reportable data elements for tumor registries. A tumor registry shall report the minimal data elements in the required status table in NAACCR Standards for Cancer Registries, Volume II, for each case which meets the criteria established in §§ 44:22:02:02 to 44:22:02:05, inclusive. These must be reported in the designated NAACCR record layout in NAACCR's Standards for Cancer Registries, Volume II.

 

          Source: 18 SDR 142, effective March 9, 1992; 29 SDR 21, effective August 27, 2002; 32 SDR 69, effective November 7, 2005.

          General Authority: SDCL 1-43-13.

          Law Implemented: SDCL 1-43-13, 1-43-14.

 

          Reference: Standards for Cancer Registries, Volume II, Data Standards and Data Dictionary, North Association of Central Cancer Registries, NAACCR, 2121 W. White Oaks Drive, Suite C, Springfield, IL 62704. Free.

 

          44:22:02:07.  Method of reporting for tumor registries. Each facility with a tumor registry shall provide to the department the data elements described in § 44:22:02:06 for all cases which meet the reporting criteria established in §§ 44:22:02:02 to 44:22:02:05, inclusive. Abstracts must be completed within six months from the date of initial diagnosis. Data must be transmitted to the central cancer registry at least on a quarterly basis, by the following dates:

 

First Quarter (January-March)	September 30 of the same year
Second Quarter (April-June)	December 31 of the same year
Third Quarter (July-September)	March 31 of the next year
Fourth Quarter (October-December)	June 30 of the next year

 

          Source: 18 SDR 142, effective March 9, 1992; 29 SDR 21, effective August 27, 2002; 32 SDR 69, effective November 7, 2005.

          General Authority: SDCL 1-43-13.

          Law Implemented: SDCL 1-43-13, 1-43-14.

 

          44:22:02:08.  Method of reporting for manual tumor registries. Repealed.

 

          Source: 18 SDR 142, effective March 9, 1992; 29 SDR 21, effective August 27, 2002; repealed, 32 SDR 69, effective November 7, 2005.

 

          44:22:02:09.01.  Method of reporting for hospitals without tumor registries, physicians, physician assistants, nurse practitioners, nurse midwives, and free-standing radiology centers. Each provider shall complete a form prescribed by the department if a cancer case is found by the department through case finding mechanisms. The provider shall complete the form and return it to the department within 30 days. If the hospitals, physician, physician assistant, nurse practitioner, nurse midwife, or free-standing radiology center is unable to complete the form, they can provide a copy of that portion of the patient's medical record that contains the minimum information necessary for the department to complete the form. The department may request disease indices from hospitals without tumor registries, physicians, physician assistants, nurse practitioners, nurse midwives, or free-standing radiology centers to assist in case finding. The disease indices shall be provided to the department within 30 days of the request.

 

          Source: 32 SDR 69, effective November 7, 2005.

          General Authority: SDCL 1-43-13.

          Law Implemented: SDCL 1-43-11, 1-43-13.

 

          44:22:02:10.  Reporting for other entities. The central cancer registry may develop an individual agreement with any entity. The central cancer registry and administration of the entity shall mutually decide how cancer cases will be made available to the central cancer registry.

 

          Source: 29 SDR 21, effective August 27, 2002; 32 SDR 69, effective November 7, 2005.

          General Authority: SDCL 1-43-13.

          Law Implemented: SDCL 1-43-11, 1-43-13.

 

          44:22:03:01.  Correcting submitted data. Upon discovering an error in a report or upon the request of the department, a reporting entity shall supply corrected or missing information.

 

          Source: 18 SDR 142, effective March 9, 1992; 32 SDR 69, effective November 7, 2005.

          General Authority: SDCL 1-43-13.

          Law Implemented: SDCL 1-43-11, 1-43-13.

 

          44:22:03:02.  Validation of information. For the purpose of assuring the quality of submitted data, each reporting entity shall allow the department to inspect such parts of a patient's medical records as are necessary to verify the accuracy and completeness of submitted data. The SDCR shall make arrangements with facility or provider for these audits with no fewer than 15 working days notice.

 

          Source: 18 SDR 142, effective March 9, 1992; 32 SDR 69, effective November 7, 2005.

          General Authority: SDCL 1-43-13.

          Law Implemented: SDCL 1-43-11, 1-43-13.

 

          44:22:03:03.  Performance of quality assurance edits. The department shall perform quality assurance edits on data entered into the central cancer registry to ensure that all data is completely and accurately recorded.

 

          Source: 18 SDR 142, effective March 9, 1992; 29 SDR 21, effective August 27, 2002; 32 SDR 69, effective November 7, 2005.

          General Authority: SDCL 1-43-13.

          Law Implemented: SDCL 1-43-11, 1-43-13.

 

          44:22:04:01.  Duty to maintain confidentiality. Information contained in the central cancer registry constitutes medical research. Confidentiality of identifying data shall be maintained in accordance with SDCL 34-14-1.

 

          Source: 18 SDR 142, effective March 9, 1992; 29 SDR 21, effective August 27, 2002; 32 SDR 69, effective November 7, 2005.

          General Authority: SDCL 1-43-13.

          Law Implemented: SDCL 1-43-11, 1-43-13, 34-14-1.

 

          44:22:04:02.  Publication of data. Published information may not contain the name of an individual who is or was the subject of a report of cancer submitted to the department and may not contain an identifying number, mark, or description which can be readily associated with an individual who is or was the subject of a report of cancer submitted to the department. All published data must be presented in such a statistical manner that no person can be identified. Data existing in cells with zero counts shall be published as "0" and cells with data counts of "1" or "2" shall be published as less than three individuals except on a statewide basis. Except as provided in § 44:22:05:01, published information may not identify reporting entities in relation to cancer data or statistics.

 

          Source: 18 SDR 142, effective March 9, 1992; 32 SDR 69, effective November 7, 2005.

          General Authority: SDCL 1-43-13.

          Law Implemented: SDCL 1-43-11, 1-43-13.

 

          44:22:04:03.  Data for research. The department may approve any applicant who submits written application to obtain access to case-specific data or case-specific and patient-identifying data to assist in the applicant's research for cancer prevention, control, and treatment in order to reduce morbidity and mortality as described in SDCL 34-14-1. The applicant shall certify that:

 

          (1)  The applicant is a qualified researcher sponsored by a public or private college or university, governmental entity, non-profit medical, sociological or psychological association, or pharmaceutical industry;

 

          (2)  The data requested will be used for scientific or medical research for the prevention, cure, or control of cancer only;

 

          (3)  Disclosure of the information is necessary to accomplish the purposes of the research;

 

          (4)  The research project has been reviewed and approved by an institutional review board on the lists of registered Institutional Review Boards or Independent Ethics Committees and approved Assurances of the Office for Human Research Protections, U.S. Department of Health and Human Services;

 

          (5)  No patient, or patient's relatives or friends, will be contacted without prior approval of the patient's physician in accordance with SDCL 34-14-5;

 

          (6)  The applicant will maintain the confidentiality and security of the data obtained by establishing adequate safeguards;

 

          (7)  The applicant will comply with all federal and state laws, and department guidelines regarding release of data with identifying information and with de-identified information;

 

          (8)  The applicant agrees to pay the department reasonable costs of data retrieval and data processing as determined and billed by the department; and

 

          (9)  The applicant will provide the results of the research to the department at no cost and not publish the results until two months after submission to the department and that any publication will acknowledge the department and its central cancer registry.

 

          Source: 32 SDR 69, effective November 7, 2005.

          General Authority: SDCL 1-43-13.

          Law Implemented: SDCL 1-43-11, 1-43-13, 34-14-1.

 

          44:22:05:01.  Requirement to prepare annual statistical summary. The department shall publish annual statistical summaries of information contained in the central cancer registry. Annual summaries of data may also be provided to any reporting entity, based on the data submitted by the entities, upon request of the reporting entity. A reporting entity may not be provided source-specific reports for data other than the entity's own.

 

          Source: 18 SDR 142, effective March 9, 1992; 29 SDR 21, effective August 27, 2002; 32 SDR 69, effective November 7, 2005.

          General Authority: SDCL 1-43-13.

          Law Implemented: SDCL 1-43-11, 1-43-13.