[Rev. 7/19/2011 11:32:20 AM]
REPORTING INFORMATION ON CANCER
457.010 Definitions.
457.030 Severability.
457.040 Types of malignant neoplasms to be reported.
457.045 Exceptions to reporting procedure.
457.050 Abstracting of information by health care facility; standards for abstracting information.
457.053 Reporting of information by medical laboratory.
457.057 Reporting of information by physician.
457.060 Confidentiality of information.
457.070 Procedures for maintaining confidentiality of information.
457.080 Procedures for taking confidential information outside the offices of the Health Division.
457.090 Mailing of confidential information; list of persons authorized to receive confidential information.
457.100 Persons with whom the State Health Officer contracts.
457.110 Disclosure of information: Authorized recipients; verification of identity.
457.120 Disclosure of information: Requirements of person seeking information.
457.130 Verification of identity of person making request by telephone.
457.140 Disclosure of information: Scientific research into cancer.
457.150 Fees.
OPERATION OF RADIATION MACHINE FOR MAMMOGRAPHY
General Provisions
457.200 Definitions.
457.205 “Anti-scatter grid” defined.
457.210 “Certificate” defined.
457.215 “Certificate for a machine” defined.
457.220 “Device for compression” defined.
457.225 “Facility for mammography” defined.
457.230 “Half-value layer” defined.
457.235 “Health Division” defined.
457.240 “Image receptor” defined.
457.245 “Machine” defined.
457.250 “Mammographer” defined.
457.255 “Mammographer’s certificate” defined.
457.260 “Operator of a facility” defined.
457.263 “Patients’ log” defined.
457.265 “Responsible provider of care” defined.
457.270 “Scattered radiation” defined.
457.275 “Source-image receptor distance” defined.
457.280 “Target” defined.
457.285 Adoption of certain publications and federal regulations by reference; review of revisions.
457.290 Granting of exemptions, exceptions or variances from requirements.
457.293 Procedure for review of actions taken by Health Division; appeals.
457.295 Fees for certificates.
457.297 Postponement of expiration of certificate for machine during review of application to renew.
457.299 Requirements for approval of applications for certificates for machines and mammographer’s certificates.
457.2995 Grounds for denial of application for renewal of certificate or withdrawal or suspension of certificate.
Administrative Requirements
457.300 Quality assurance and control: General requirements.
457.305 Quality assurance: Preparation and contents of manual; allocation of adequate time to perform duties.
457.310 Maintenance of records generally; contents and action on records of tests for quality assurance; maintenance of signature or initial cards; recording of number of films or projections used for patients.
457.312 Maintenance of records of patients; imaging requirements for digital mammography machine.
457.313 Preliminary interpretation and reports of mammograms; standards for mammography records and reports.
457.315 Maintenance of record of repair or calibration of equipment used to perform test for quality assurance.
457.320 Maintenance of record documenting maintenance of equipment used for mammography.
457.325 Documentation required for imaging processing systems and printing equipment.
457.330 Plotting and evaluation of certain information on control chart; action required when information is not within applicable control limits.
457.335 Inspection of facility and certain records.
Personnel
457.340 Physician who supervises operation of machine: Preparation, review and updating of manual of procedures; compliance with standards; notification of violation of chapter.
457.345 Interpreter of mammograms: Prerequisites to certification of machine.
457.347 Interpreter of mammograms: Temporary employment at other facilities.
457.350 Mammographer: Requirements for certification.
457.355 Program of instruction in mammography: General requirements.
457.357 Program of instruction in mammography: Certification of person to provide training.
457.360 Mammographer: Duties.
457.365 Mammographer: Prohibited acts.
457.370 Mammographer: Renewal of certificate; continuing education.
Equipment
457.373 Compliance with certain federal requirements.
457.375 Standards for and approval of machine.
457.390 Required equipment, intensifying screens and film.
457.395 Darkroom: Prohibited activities; cleanliness; safelight.
Tests for Quality Assurance
457.400 Tests required after certain repairs or replacements of components.
457.410 Qualification of persons to perform tests.
457.420 Tests of film processing equipment; action on results.
457.425 Tests of image quality.
457.435 Analyses of rejected mammograms.
457.445 Verification of safe operating condition of machine; record of findings.
CANCER DRUG DONATION PROGRAM
General Provisions
457.500 Definitions.
457.505 “Board” defined.
457.510 “Cancer drug” defined.
457.515 “Dispense” defined.
457.520 “Distribute” defined.
457.525 “Health clinic” defined.
457.530 “Medical facility” defined.
457.535 “Pharmacy” defined.
457.540 “Program” defined.
457.545 “Provider of health care” defined.
Participation of Persons in Program
457.555 Eligibility for participation in Program to receive cancer drug.
457.560 Submission of application to participate; written notice of approval or denial by Board.
Participation of Pharmacies, Medical Facilities, Health Clinics and Providers of Health Care in Program
457.565 Eligibility for participation in Program.
457.570 Submission of application to participate; written notice of approval or denial by Board.
457.575 Compliance with federal and state laws and regulations required.
Administration of Program; Fees
457.580 Board to establish and maintain registry of participants; notification to Board of certain changes in information or status.
457.585 Donating, dispensing and storage of cancer drugs.
457.587 Restrictions on donated cancer drugs.
457.590 Maintenance of records by pharmacy, medical facility, health clinic or provider of health care that participates in Program.
457.595 Handling fee.
REPORTING INFORMATION ON CANCER
NAC 457.010 Definitions. (NRS 457.065, 457.240) As used in NAC 457.010 to 457.150, inclusive, unless the context otherwise requires:
1. “Cancer” has the meaning ascribed to it in NRS 457.020.
2. “Health care facility” has the meaning ascribed to it in NRS 457.020.
3. “Health Division” means the Health Division of the Department of Health and Human Services.
4. “Malignant neoplasm” means a virulent or potentially virulent tumor, regardless of the tissue of origin.
5. “Medical laboratory” has the meaning ascribed to it in NRS 652.060.
6. “Physician” means a physician licensed pursuant to chapter 630 or 633 of NRS.
7. “Registry” means the office in which the State Health Officer conducts the program for reporting information on cancer and maintains records containing that information.
[Bd. of Health, Malignant Neoplasms Reg. § 1, eff. 3-19-70]—(NAC A 12-3-84; 1-24-92; 10-22-93; R075-98, 11-18-98)
NAC 457.030 Severability. (NRS 457.065, 457.240) If any of the provisions of NAC 457.010 to 457.150, inclusive, or any application thereof to any person, thing or circumstance is held invalid, the State Board of Health intends that such invalidity not affect the remaining provisions or applications to the extent that they can be given effect.
(Added to NAC by Bd. of Health, eff. 12-3-84; A 1-24-92)
NAC 457.040 Types of malignant neoplasms to be reported. (NRS 457.065, 457.240) Except as otherwise provided in NAC 457.045, the types of malignant neoplasms which must be reported pursuant to NRS 457.240 are as follows:
1. Neoplasms, not otherwise specified:
Neoplasm, malignant
Neoplasm, metastatic
Neoplasm, malignant, uncertain whether primary or metastatic
Tumor cells, malignant
Malignant tumor, small cell type
Malignant tumor, giant cell type
Malignant tumor, fusiform cell type
Malignant tumor, spindle cell type
2. Epithelial neoplasms, not otherwise specified:
Carcinoma, in situ, not otherwise specified
Intraepithelial carcinoma, not otherwise specified
Carcinoma, not otherwise specified
Epithelial tumor, malignant
Carcinoma, metastatic, not otherwise specified
Carcinomatosis
Epithelioma, malignant
Large cell carcinoma, not otherwise specified
Carcinoma, undifferentiated type, not otherwise specified
Carcinoma, anaplastic type, not otherwise specified
Pleomorphic carcinoma
Giant cell and spindle cell carcinoma
Giant cell carcinoma
Spindle cell carcinoma
Pseudosarcomatous carcinoma
Polygonal cell carcinoma
Spheroidal cell carcinoma
Small cell carcinoma, not otherwise specified
Reserve cell carcinoma
Round cell carcinoma
Oat cell carcinoma
Small cell carcinoma, fusiform cell type
3. Papillary and squamous cell neoplasms:
Papillary carcinoma, in situ
Papillary carcinoma
Verrucous carcinoma
Papillary squamous cell carcinoma
Papillary epidermoid carcinoma
Squamous cell carcinoma, in situ
Epidermoid carcinoma, in situ
Intraepidermal carcinoma
Intraepithelial squamous cell carcinoma
Squamous cell carcinoma
Epidermoid carcinoma
Spinous cell carcinoma
Squamous carcinoma
Squamous cell epithelioma
Squamous cell carcinoma, metastatic
Squamous cell carcinoma, keratinizing type
Squamous cell carcinoma, large cell, nonkeratinizing type
Squamous cell carcinoma, small cell, nonkeratinizing type
Squamous cell carcinoma, spindle cell type
Adenoid squamous cell carcinoma
Squamous cell carcinoma, micro-invasive
Queyrat’s erythroplasia
Bowen’s disease
Intraepidermal squamous cell carcinoma, Bowen’s type
Lymphoepithelial carcinoma
Lymphoepithelioma
4. Basal cell neoplasms:
Basal cell carcinoma, not otherwise specified
Multicentric basal cell carcinoma
Basal cell carcinoma, morphea type
Basal cell carcinoma, fibroepithelial type
Basosquamous carcinoma
Metatypical carcinoma
5. Transitional cell papillomas and carcinomas:
Transitional cell carcinoma, in situ
Transitional cell carcinoma
Transitional carcinoma
Urothelial carcinoma
Schneiderian carcinoma
Transitional cell carcinoma, spindle cell type
Basaloid carcinoma
Cloacogenic carcinoma
Papillary transitional cell carcinoma
6. Adenocarcinomas:
Adenocarcinoma
Adenocarcinoma, metastatic
Scirrhous adenocarcinoma
Linitis plastica
Superficial spreading adenocarcinoma
Adenocarcinoma, intestinal type
Carcinoma, diffuse type
Islet cell carcinoma
Islet cell adenocarcinoma
Insulinoma, malignant
Beta-cell tumor, malignant
Glucagonoma, malignant
Alpha-cell tumor, malignant
Gastrinoma, malignant
G cell tumor, malignant
Mixed islet cell and exocrine adenocarcinoma
Cholangiocarcinoma
Bile duct carcinoma
Bile duct adenocarcinoma
Bile duct cystadenocarcinoma
Hepatocellular carcinoma
Liver cell carcinoma
Hepatocarcinoma
Hepatoma, malignant
Combined hepatocellular carcinoma and cholangiocar-cinoma
Hepatocholangiocarcinoma
Trabecular adenocarcinoma
Trabecular carcinoma
Adenoid cystic carcinoma
Adenocystic carcinoma
Adenocarcinoma, cylindroid type
Cribriform carcinoma
Adenocarcinoma in adenomatous polyp
Adenocarcinoma in tubular adenoma
Carcinoma in adenomatous polyp
Adenocarcinoma in polypoid adenoma
Tubular adenocarcinoma
Tubular carcinoma
Adenocarcinoma in adenomatous, polyposis coli
Solid carcinoma
Carcinoma simplex
Carcinoid tumor, malignant
Carcinoid tumor, argentaffin, malignant
Argentaffinoma, malignant
Carcinoid tumor, nonargentaffin, malignant
Musocarcinoid tumor, malignant
Goblet cell carcinoid
Composite carcinoid
Bronchiolo-alveolar adenocarcinoma
Alveolar cell carcinoma
Bronchiolo-alveolar carcinoma
Bronchiolar adenocarcinoma
Bronchiolar carcinoma
Terminal bronchiolar carcinoma
Alveolar adenocarcinoma
Alveolar carcinoma
Papillary adenocarcinoma
Adenocarcinoma in villous adenoma
Villous adenocarcinoma
Chromophobe carcinoma
Chromophobe adenocarcinoma
Acidophil carcinoma
Acidophil adenocarcinoma
Eosinophil carcinoma
Eosinophil adenocarcinoma
Mixed acidophil-basophil carcinoma
Oxyphilic adenocarcinoma
Oncocytic carcinoma
Oncocytic adenocarcinoma
Hurthle cell carcinoma
Hurthle cell adenocarcinoma
Basophil carcinoma
Basophil adenocarcinoma
Mucoid cell adenocarcinoma
Clear cell adenocarcinoma
Clear cell adenocarcinoma, mesonephroid type
Clear cell carcinoma
Renal cell carcinoma
Renal cell adenocarcinoma
Grawitz tumor
Hypernephroma
Granular cell carcinoma
Granular cell adenocarcinoma
Water-clear cell adenocarcinoma
Water-clear cell carcinoma
Mixed cell adenocarcinoma
Follicular adenocarcinoma
Follicular carcinoma
Follicular adenocarcinoma, well differentiated type
Follicular adenocarcinoma, trabecular type
Wuchernde Struma Langhans
Papillary and follicular adenocarcinoma
Nonencapsulated sclerosing carcinoma
Nonencapsulated sclerosing adenocarcinoma
Nonencapsulated sclerosing tumor
Adrenal cortical carcinoma
Adrenal cortical adenocarcinoma
Adrenal cortical tumor, malignant
Endometrioid carcinoma
Endometrioid adenocarcinoma
Endometrioid cystadenocarcinoma
Endometrioid adenofibroma, malignant
Endometrioid cystadenofibroma, malignant
7. Adnexal and skin appendage neoplasms:
Skin appendage carcinoma
Adnexal carcinoma
Sweat gland adenocarcinoma
Sweat gland carcinoma
Sweat gland tumor, malignant
Apocrine adenocarcinoma
Sebaceous adenocarcinoma
Sebaceous carcinoma
Ceruminous adenocarcinoma
Ceruminous carcinoma
8. Mucoepidermoid neoplasms:
Mucoepidermoid carcinoma
9. Cystic, mucinous and serous neoplasms:
Cystadenocarcinoma
Serous cystadenocarcinoma
Serous adenocarcinoma
Papillary cystadenocarcinoma
Papillocystic adenocarcinoma
Papillary serous cystadenocarcinoma
Papillary serous adenocarcinoma
Serous surface papillary carcinoma
Mucinous cystadenocarcinoma
Pseudomucinous adenocarcinoma
Pseudomucinous cystadenocarcinoma
Papillary mucinous cystadenocarcinoma
Papillary pseudomucinous
Cystadenocarcinoma
Mucinous adenocarcinoma
Mucinous carcinoma
Colloid adenocarcinoma
Colloid carcinoma
Gelatinous adenocarcinoma
Gelatinous carcinoma
Mucoid adenocarcinoma
Mucoid carcinoma
Mucous adenocarcinoma
Mucous carcinoma
Pseudomyxoma peritonei
Mucin-producing adenocarcinoma
Mucin-producing carcinoma
Mucin-secreting adenocarcinoma
Mucin-secreting carcinoma
Signet ring cell carcinoma
Signet ring cell adenocarcinoma
Metastatic signet ring cell carcinoma
Krukenberg tumor
10. Ductal, lobular and medullary neoplasms:
Intraductal carcinoma, noninfiltrating
Intraduct carcinoma, in situ
Infiltrating duct carcinoma
Infiltrating duct adenocarcinoma
Duct adenocarcinoma
Duct carcinoma
Duct cell carcinoma
Ductal carcinoma
Comedocarcinoma, noninfiltrating
Comedocarcinoma
Juvenile carcinoma of the breast
Secretory carcinoma of the breast
Noninfiltrating intraductal papillary adenocarcinoma
Noninfiltrating intracystic carcinoma
Medullary carcinoma
Medullary adenocarcinoma
Parafollicular cell carcinoma
C cell carcinoma
Medullary carcinoma with amyloid stroma
Solid carcinoma with amyloid stroma
Medullary carcinoma with lymphoid stroma
Lobular carcinoma, in situ
Lobular carcinoma, noninfiltrating
Lobular carcinoma
Lobular adenocarcinoma
Infiltrating lobular carcinoma
Infiltrating ductular carcinoma
Inflammatory carcinoma
Inflammatory adenocarcinoma
Paget’s disease, mammary
Paget’s disease of breast
Paget’s disease and infiltrating duct carcinoma of breast
Paget’s disease, extramammary
Acinar cell carcinoma
Acinic cell adenocarcinoma
Acinar adenocarcinoma
Acinar carcinoma
11. Complex epithelial neoplasms:
Adenosquamous carcinoma
Adenocarcinoma with squamous metaplasia
Adenoacanthoma
Adenocarcinoma with cartilaginous and osseous metaplasia
Adenocarcinoma with spindle cell metaplasia
Adenocarcinoma with apocrine metaplasia
Thymoma, malignant
Thymic carcinoma
12. Specialized gonadal neoplasms:
Theca cell carcinoma
Thecoma, malignant
Granulosa cell tumor, malignant
Granulosa cell carcinoma
Androblastoma, malignant
Arrhenoblastoma, malignant
Sertoli cell carcinoma
Leydig cell tumor, malignant
Interstitial cell tumor, malignant
13. Paragangliomas and glomus tumors:
Paraganglioma, malignant
Extra-adrenal paraganglioma, malignant
Nonchromaffin paraganglioma, malignant
Pheochromocytoma, malignant
Pheochromoblastoma
Glomangiosarcoma
Glomoid sarcoma
14. Nevi and melanomas:
Malignant melanoma
Melanoma
Melanocarcinoma
Nevocarcinoma
Melanosarcoma
Nodular melanoma
Balloon cell melanoma
Amelanotic melanoma
Malignant melanoma in junctional nevus
Precancerous malanosis
Malignant melanoma in precancerous melanosis
Hutchinson’s melanotic freckle
Lentigo maligna
Malignant melanoma in Hutchinson’s melanotic freckle
Lentigo maligna melanoma
Superficial spreading melanoma
Malignant melanoma in giant pigmented nevus
Epithelioid cell melanoma
Epithelioid cell melanosarcoma
Spindle cell melanoma
Spindle cell melanoma, type A
Spindle cell melanoma, type B
Mixed epithelioid and spindle cell melanoma
Blue nevus, malignant
15. Soft tissue tumors and sarcomas:
Sarcoma
Soft tissue tumor, malignant
Mesenchymal tumor, malignant
Sarcomatosis
Spindle cell sarcoma
Giant cell sarcoma
Pleomorphic cell sarcoma
Small cell sarcoma
Round cell sarcoma
Epithelioid cell sarcoma
16. Fibromatous neoplasms:
Fibrosarcoma
Fibromyxosarcoma
Periosteal fibrosarcoma
Periosteal sarcoma
Fascial fibrosarcoma
Infantile fibrosarcoma
Congenital fibrosarcoma
Fibrous histiocytoma, malignant
Fibroxanthoma, malignant
Fibroxanthosarcoma
Dermatofibrosarcoma
Dermatofibrosarcoma protuberans
Myxosarcoma
Liposarcoma
Fibroliposarcoma
Liposarcoma, well differentiated type
Myxoid liposarcoma
Myxoliposarcoma
Embryonal liposarcoma
Round cell liposarcoma
Pleomorphic liposarcoma
Mixed type liposarcoma
Angiomyoliposarcoma
17. Myomatous neoplasms:
Leiomyosarcoma
Epithelioid leiomyosarcoma
Angiomyosarcoma
Myosarcoma
Rhabdomyosarcoma
Rhabdosarcoma
Pleomorphic rhabdomyosarcoma
Mixed type rhabdomyosarcoma
Embryonal rhabdomyosarcoma
Sarcoma botryoides
Botryoid sarcoma
Alveolar rhabdomyosarcoma
18. Complex mixed and stromal neoplasms:
Endometrial stromal sarcoma
Endometrial sarcoma
Stromal sarcoma
Mixed tumor, malignant
Mixed tumor, salivary gland type malignant
Carcinoma in pleomorphic adenoma
Mullerian mexed tumor
Mesodermal mexed tumor
Nephroblastoma
Wilms’s tumor
Adenosarcoma
Epithelian nephroblastoma
Mesenchymal nephroblastoma
Hepatoblastoma
Embryonal hepatoma
Carcinosarcoma
Carcinosarcoma, embryonal type
Pneumoblastoma
Mesenchymoma, malignant
Mixed mesenchymal sarcoma
Embryonal sarcoma
19. Fibroepithelial neoplasms:
Brenner tumor, malignant
Cystosarcoma phyllodes, malignant
20. Synovial neoplasms:
Synovial sarcoma
Synovioma
Synovioma, malignant
Synovial sarcoma, spindle cell type
Synovial sarcoma, epithelioid cell type
Synovial sarcoma, biphasic type
Clear cell sarcoma of tendons and aponeuroses
21. Mesothelial neoplasms:
Mesothelioma, malignant
Mesothelioma
Mesothelial sarcoma
Fibrous mesothelioma, malignant
Fibrous mesothelioma
Epithelioid mesothelioma, malignant
Epithelioid mesothelioma
Mesothelioma, biphasic type, malignant
Mesothelioma, biphasic type
22. Germ cell neoplasms:
Dysgerminoma
Seminoma
Seminoma, anaplastic type
Spermatocytic seminoma
Spermatocytoma
Germinoma
Embryonal carcinoma
Embryonal adenocarcinoma
Endodermal sinus tumor
Yolk sac tumor
Polyvesicular vitelline tumor
Orchioblastoma
Embryonal carcinoma, infantile type
Polyembryoma
Embryonal carcinoma, polyembryonal type
Teratoma, malignant
Embryonal teratoma
Teratoblastoma, malignant
Immature teratoma
Teratocarcinoma
Mixed embryonal carcinoma and teratoma
Malignant teratoma, undifferentiated type
Malignant teratoma, anaplastic type
Malignant teratoma, intermediate type
Dermoid cyst with malignant transformation
Struma ovarii, malignant
23. Trophablastic neoplasms:
Malignant hydatidiform mole
Choriocarcinoma
Chorionepithelioma
Chorioepithelioma
Choriocarcinoma combined with teratoma
Choriocarcinoma combined with embryonal carcinoma
Malignant teratoma, trophoblastic type
24. Mesonephromas:
Mesonephroma, malignant
Mesonephric adenocarcinoma
Mesonephroma
Mesometanephric carcinoma
Wolffian duct carcinoma
Hemangiosarcoma
Angiosarcoma
Kupffer cell sarcoma
Hemangioendothelioma, malignant
Hemangioendothelial sarcoma
Kaposi’s sarcoma
Multiple hemorrhagic sarcoma
Hemangiopericytoma, malignant
25. Lymphatic vessel tumors:
Lymphangiosarcoma
Lymphangioendothelial sarcoma
Lymphangioendothelioma, malignant
26. Osteomas and osteosarcomas:
Osteosarcoma
Osteogenic sarcoma
Osteochondrosarcoma
Osteoblastic sarcoma
Chondroblastic osteosarcoma
Fibroblastic osteosarcoma
Osteofibrosarcoma
Telangiectatic osteosarcoma
Osteosarcoma in Paget’s disease of bone
Juxtacortical osteosarcoma
Juxtacortical osteogenic sarcoma
Parosteal osteosarcoma
Periosteal osteogenic sarcoma
27. Chondromatous neoplasms:
Chondrosarcoma
Fibrochondrosarcoma
Juxtacortical chondrosarcoma
Chondroblastoma, malignant
Mesenchymal chondrosarcoma
28. Giant cell tumors:
Giant cell tumor of bone, malignant
Osteoclastoma, malignant
Giant cell sarcoma of bone
Malignant giant cell tumor of soft parts
29. Miscellaneous bone tumors:
Ewing’s sarcoma
Ewing’s tumor
Endothelial sarcoma of bone
Adamantinoma of long bones
Tibial adamantinoma
30. Odontogenic tumors:
Odontogenic tumor, malignant
Odontogenic carcinoma
Odontogenic sarcoma
Intraosseous carcinoma
Ameloblastic odontosarcoma
Ameloblastoma, malignant
Adamantinoma, malignant
Ameloblastic fibrosarcoma
Ameloblastic sarcoma
Odontogenic fibrosarcoma
31. Miscellaneous tumors:
Caraniopharyngioma
Pineloma
Pinecytoma
Pineoblastoma
Chordoma
32. Gliomas:
Glioma, malignant
Glioma
Gliosarcoma
Gliomatosis cerebri
Mixed glioma
Mixed oligo-astrocytoma
Subependymal glioma
Subependymoma
Subependymal astrocytoma
Subependymal giant cell astrocytoma
Choroid plexus papilloma, malignant
Choroid plexus papilloma, anaplastic type
Ependymoma
Epithelial ependymoma
Ependymoma, anaplastic type
Ependymoblastoma
Papillary ependymoma
Myxopapillary ependymoma
Astrocytoma
Astroglioma
Astrocytic glioma
Cystic astrocytoma
Astrocytoma, anaplastic type
Protoplasmic astrocytoma
Gemistocytic astrocytoma
Gemistocytoma
Fibrillary astrocytoma
Fibrous astrocytoma
Pilocytic astrocytoma
Piloid astrocytoma
Juvenile astrocytoma
Spongioblastoma
Spongioblastoma polare
Astroblastoma
Glioblastoma
Glioblastoma multiforme
Spongioblastoma multiforme
Giant cell glioblastoma
Glioblastoma with sarcomatous component
Primitive polar spongioblastoma
Oligodendroglioma
Oligodendroglioma, anaplastic type
Oligodendroblastoma
Medulloblastoma
Desmoplastic medulloblastoma
Circumscribed arachnoidal cerebellar sarcoma
Medullomyoblastoma
Cerebral sarcoma
Monstrocellular sarcoma
33. Neuroepitheliomatous neoplasms:
Ganglioneuroblastoma
Neuroblastoma
Sympathicoblastoma
Sympathicogonioma
Sympathogonioma
Medulloepithelioma
Diktyoma
Terotoid medulloepithelioma
Neuroepithelioma
Spongioneuroblastoma
Retinoblastoma
Olfactory neurogenic tumor
Esthesioneurocytoma
Esthesioneuroblastoma
Olfactory neuroblastoma
Esthesioneuroepithelioma
Olfactory neuriepithelioma
34. Meningiomas:
Meningioma, malignant
Leptomeningeal sarcoma
Meningeal sarcoma
Meningothelial sarcoma
Meningeal sarcomatosis
35. Nerve sheath tumors:
Neurofibrosarcoma
Neurogenic sarcoma
Neurosarcoma
Neurilemmoma, malignant
Schwannoma, malignant
Neurilemmosarcoma
36. Granular cell tumors and alveolar soft part sarcoma:
Granular cell tumor, malignant
Granular cell myoblastoma, malignant
Alveolar soft part sarcoma
37. Lymphomas, not otherwise specified or diffuse:
Malignant lymphoma
Lymphoma
Malignant lymphoma, diffuse
Malignant lymphoma, non-Hodgkin’s type
Malignant lymphoma, undifferentiated cell type
Malignant lymphoma, undifferentiated cell type, non-Burkitt’s
Malignant lymphoma, stem cell type
Stem cell lymphoma
Malignant lymphoma, convoluted cell type
Malignant lymphoma, lymphoblastic, convoluted cell type
Lymphosarcoma
Malignant lymphoma, lymphoplasmacytoid type
Malignant lymphoma, immunoblastic type
Immunoblastic sarcoma
Immunoblastic lymphosarcoma
Immunoblastic lymphoma
Malignant lymphoma, mixed lymphocytic-histiocytic, not otherwise specified
Malignant lymphoma, centroblastic-centrocystic, diffuse
Germinoblastoma, diffuse
Malignant lymphoma, follicular center cell
Malignant lymphoma, lymphocytic, well differentiated
Malignant lymphoma, lymphocytic, intermediate differentiation
Malignant lymphoma, centrocytic
Malignant lymphoma, germinocytic
Malignant lymphoma, follicular center cell, cleaved
Malignant lymphoma, lymphocytic, poorly differentiated
Prolymphocytic lymphosarcoma
Malignant lymphoma, centroblastic type
Malignant lymphoma, follicular center cell, noncleaved
38. Reticulosarcomas:
Reticulosarcoma
Reticulosarcoma, pleomorphic cell type
Reticulosarcoma, nodular
39. Hodgkin’s disease:
Hodgkin’s disease
Lymphogranuloma, malignant
Lymphogranulomatosis, malignant
Malignant lymphoma, Hodgkin’s type
Hodgkin’s disease, lymphocytic predominance
Hodgkin’s disease, mixed cellularity
Hodgkin’s disease, lymphocytic depletion
Hodgkin’s disease, lymphocytic depletion, diffuse fibrosis
Hodgkin’s disease, lymphocytic depletion, reticular type
Hodgkin’s disease, nodular sclerosis
Hodgkin’s disease, nodular sclerosis, cellular phase
Hodgkin’s paragranuloma
Hodgkin’s granuloma
Hodgkin’s sarcoma
40. Lymphomas, nodular or follicular:
Malignant lymphoma, nodular
Malignant lymphoma, follicular
Nodular lymphosarcoma
Follicular lymphosarcoma
Brill-Symmer’s disease
Giant follicular lymphoma
Lymphocytic lymphoma, nodular
Malignant lymphoma, mixed lymphocytic-histiocytic, nodular
Malignant lymphoma, centroblastic-centrocytic, follicular
Germinoblastoma, follicular
Malignant lymphoma, lymphocytic, well differentiated, nodular
Malignant lymphoma, lymphocytic, intermediate differentiation, nodular
Malignant lymphoma, follicular center cell, cleaved, follicular
Malignant lymphoma, lymphocytic, poorly differentiated, nodular
Malignant lymphoma, centroblastic type, follicular
Germinoblastic sarcoma, follicular
Malignant lymphoma, follicular center cell, noncleaved, follicular
41. Mycosis fungoides:
Mycosis fungoides
Sezary’s disease
Sezary’s syndrome
42. Miscellaneous reticuloendothelial neoplasms:
Microglioma
Malignant histiocytosis
Malignant reticuloendotheliosis
Malignant reticulosis
Histiocytic medullary reticulosis
Letterer-Siwe’s disease
43. Plasma cell tumors:
Plasma cell myeloma
Plasmacytic myeloma
Multiple myeloma
Myeloma, not otherwise specified
Myelomatosis
Plasma cell tumor, malignant
Plasma cell sarcoma
44. Mast cell tumors:
Mast cell sarcoma
Malignant mast cell tumor
Malignant mastocytoma
Malignant mastocytosis
Systemic tissue mast cell disease
45. Burkitt’s tumor:
Burkitt’s tumor
Burkitt’s lymphoma
Malignant lymphoma, undifferentiated, Burkitt’s type
Malignant lymphoma, lymphoblastic, Burkitt’s type
46. Leukemias:
Leukemia
Acute leukemia
Stem cell leukemia
Blast leukemia
Blastic leukemia
Undifferentiated leukemia
Subacute leukemia
Chronic leukemia
Aleukemic leukemia
47. Compound leukemias:
Compound leukemia
Mixed leukemia
48. Lymphoid leukemias:
Lymphoid leukemia
Lymphocytic leukemia
Lymphatic leukemia
Acute lymphoid leukemia
Subacute lymphoid leukemia
Chronic lymphoid leukemia
Aleukemic lymphoid leukemia
Prolymphocytic leukemia
49. Plasma cell leukemias:
Plasma cell leukemia
Plasmacytic leukemia
50. Erythroleukemias:
Erythroleukemia
Erythremic myelosis
Acute erythremia
Di Guglielmo’s disease
Guglielmo’s disease
Acute erythremic myelosis
Chronic erythremia
51. Lymphosarcoma cell leukemias:
Lymphosarcoma cell leukemia
52. Myeloid leukemias:
Myeloid leukemia
Granulocytic leukemia
Myelogenous leukemia
Myelosis
Myelomonocytic leukemia
Acute myeloid leukemia
Acute granulocytic leukemia
Blastic granulocytic leukemia
Acute Myelogenous leukemia
Myeloblastic leukemia
Acute myelocytic leukemia
Acute myelomonocytic leukemia
Acute myelosis
Subacute myeloid leukemia
Chronic myeloid leukemia
Chronic granulocytic leukemia
Myelocytic leukemia
Chronic myelogenous leukemia
Chronic myelomonocytic leukemia
Naegeli-type monocytic leukemia
Chronic myelosis
Aleukemic myeloid leukemia
Aleukemic granulocytic leukemia
Aleukemic myelogenous leukemia
Aleukemic myelosis
Neutrophilic leukemia
Acute promyelocytic leukemia
53. Basophilic leukemias:
Basophilic leukemia
54. Eosinophilic leukemias:
Eosinophilic leukemia
55. Monocytic leukemias:
Monocytic leukemia
Histiocytic leukemia
Schilling-type monocytic leukemia
Monocytoid leukemia
Acute monocytic leukemia
Acute monocytoid leukemia
Monoblastic leukemia
Subacute monocytic leukemia
Subacute monacytoid leukemia
Chronic monocytic leukemia
Chronic monocytoid leukemia
Aleukemic monocytic leukemia
Aleukemic monocytoid leukemia
56. Miscellaneous leukemias:
Mast cell leukemias
Megakaryocytic leukemia
Megakaryocytoid leukemia
Thrombocytic leukemia
Megakaryocytic myelosis
Myeloid sarcoma
Chloroma
Granulocytic sarcoma
Myelosarcoma
Hairy cell leukemia
Leukemic reticuloendotheliosis
57. No microscopic confirmation of tumor:
No microscopic confirmation; clinically malignant tumor (cancer)
No microscopic confirmation; clinically metastatic tumor (cancer)
(Added to NAC by Bd. of Health, eff. 12-3-84; A by R075-98, 11-18-98)
NAC 457.045 Exceptions to reporting procedure. (NRS 457.065, 457.240) Carcinoma in situ of the cervix and noninvasive basal and squamous cell carcinomas of the skin are not required to be reported pursuant to NAC 457.040.
(Added to NAC by Bd. of Health by R075-98, eff. 11-18-98)
NAC 457.050 Abstracting of information by health care facility; standards for abstracting information. (NRS 457.065, 457.240)
1. Each health care facility shall provide to the State Health Officer information concerning malignant neoplasms by abstracting information on a form prescribed by the State Health Officer or a designee thereof.
2. Except as otherwise provided in subsection 3, each health care facility shall abstract information in conformance with the standards for abstracting information concerning malignant neoplasms of the Commission on Cancer of the American College of Surgeons as set forth in the Registry Operations and Data Standards (ROADS) Manual, 1996 edition, which is hereby adopted by reference, and any subsequent revision or amendment to the standards established by the Commission on Cancer of the American College of Surgeons. A copy of the manual may be obtained from the American College of Surgeons, 633 North Saint Clair Street, Chicago, Illinois 60611-3211, for the price of $25.
3. The State Health Officer shall review any revision or amendment to the standards specified in subsection 2 to determine whether the revision or amendment is appropriate for this State. Ten days after the standards specified in subsection 2 are revised or amended, a health care facility shall abstract information in conformance with the revision or amendment unless the State Health Officer files an objection to the amendment or revision with the State Board of Health within 10 days after the standards are revised or amended.
4. A health care facility which does not use the staff of the Health Division to abstract information from its records shall cause to have abstracted and reported to the Health Division the malignant neoplasms listed in NAC 457.040 in the manner required by this section.
5. If a health care facility with 100 beds or more does not use the staff of the Health Division to abstract information from its records concerning malignant neoplasms, it shall cause to have abstracted and reported to the Health Division, pursuant to subsection 4, the malignant neoplasms listed in NAC 457.040 using an electronic means approved by the State Health Officer or the designee, unless an exemption from this requirement is granted by the State Health Officer.
(Added to NAC by Bd. of Health, eff. 12-3-84; A 10-22-93; R075-98, 11-18-98)
NAC 457.053 Reporting of information by medical laboratory. (NRS 457.065, 457.240)
1. A medical laboratory that obtains a specimen of human tissue which, upon examination, shows evidence of cancer shall, within 10 working days after the date that the pathology report is completed, provide information concerning its findings to the State Health Officer using an electronic means approved by the State Health Officer or a designee thereof.
2. The information provided by a medical laboratory pursuant to subsection 1 must include, without limitation:
(a) The name, address, date of birth, gender and social security number of the person from whom the specimen was obtained;
(b) The name and the address or telephone number of the physician who ordered the examination of the specimen;
(c) The name and the address or telephone number of the medical laboratory that examined the specimen;
(d) The final diagnosis from the pathology report; and
(e) Any other relevant information from the pathology report, including, without limitation:
(1) The anatomical site of the lesion;
(2) The size of the lesion;
(3) The stage of the disease and the grade of tumor;
(4) The lesion margin status, if available; and
(5) Lymphatic involvement, if available.
(Added to NAC by Bd. of Health by R075-98, eff. 11-18-98)
NAC 457.057 Reporting of information by physician. (NRS 457.065, 457.240)
1. Except as otherwise provided in subsection 3, a physician who has a case in which he or she diagnoses a patient as having cancer or provides treatment to a patient with cancer shall, within 10 working days after the date of the diagnosis or the date of the first treatment, provide information to the State Health Officer concerning the case on a form prescribed by the State Health Officer or a designee thereof, or by an electronic means approved by the State Health Officer or the designee.
2. Information provided by a physician pursuant to subsection 1 must include, without limitation:
(a) The name, address, date of birth, gender, race or ethnicity, and social security number of the patient;
(b) The name and the address or telephone number of the physician making the report;
(c) The final diagnosis from the pathology report; and
(d) Any other relevant information from the pathology report, including, without limitation:
(1) The anatomical site of the lesion;
(2) The size of the lesion;
(3) The stage of the disease and the grade of tumor;
(4) The lesion margin status, if available; and
(5) Lymphatic involvement, if available.
3. A physician is not required to provide information pursuant to this section if the patient is directly referred to or has been previously admitted to a hospital, medical laboratory or other facility which is required to report similar information pursuant to this chapter.
(Added to NAC by Bd. of Health by R075-98, eff. 11-18-98)
NAC 457.060 Confidentiality of information. (NRS 457.065, 457.240) All documents in the possession of the registry which contain names of patients, physicians, hospitals or medical laboratories are confidential except the list of names of hospitals which report information to the registry and the list of names of medical laboratories which report information to the registry.
(Added to NAC by Bd. of Health, eff. 12-3-84; A by R075-98, 11-18-98)
NAC 457.070 Procedures for maintaining confidentiality of information. (NRS 457.065, 457.240) Each employee of the Health Division who has access to confidential information of the registry shall comply with the following procedures for maintaining the confidentiality of that information:
1. All files containing confidential information, including, without limitation, the indexes for access to other files, must be locked when not in use.
2. All files on a computer containing confidential information, including, without limitation, the indexes for access to other files, must be closed and protected by password when not in use.
3. Passwords created pursuant to subsection 2 must be changed at least every 30 days.
4. All documents containing confidential information must be out of sight when an employee is away from his or her desk.
5. Keys to the office of the registry may be issued to and used only by employees so authorized by the State Health Officer.
6. The doors to the registry must be locked at all times when the office is vacant.
(Added to NAC by Bd. of Health, eff. 12-3-84; A by R075-98, 11-18-98)
NAC 457.080 Procedures for taking confidential information outside the offices of the Health Division. (NRS 457.065, 457.240) Each employee of the Health Division who takes confidential information of the registry outside the offices of the Division shall comply with the following procedures:
1. Any documents or files on a computer containing confidential information must be kept in the employee’s briefcase when the documents or files on a computer are not in use.
2. If the employee takes any such document or file on a computer home or to a hotel or motel, the employee must:
(a) Safeguard it to the greatest extent possible; and
(b) Protect it from view by unauthorized persons.
3. The contents of such a document or file on a computer must not be discussed with the employee’s relatives or friends.
4. If a briefcase or other container with such a document or computer file is to be:
(a) Left in the employee’s car, the container must be locked in the trunk of the car.
(b) Taken as baggage on an airplane, bus or other carrier, the container must be kept in the employee’s possession and must not be checked with the carrier unless the size or weight of the container precludes its being retained in the employee’s possession.
(Added to NAC by Bd. of Health, eff. 12-3-84; A by R075-98, 11-18-98)
NAC 457.090 Mailing of confidential information; list of persons authorized to receive confidential information. (NRS 457.065, 457.240)
1. If confidential information of the registry is to be mailed to a physician or health care facility, the envelope or container must be addressed directly to the physician or to the person designated by the health care facility to receive such information.
2. The State Health Officer shall keep a list of the persons who have been designated by the chief administrator of the health care facility to receive confidential information of the registry.
(Added to NAC by Bd. of Health, eff. 12-3-84; A 10-22-93)
NAC 457.100 Persons with whom the State Health Officer contracts. (NRS 457.065, 457.240) If the State Health Officer contracts with another person to perform data processing or other services using the confidential information of the registry, the other person shall maintain the confidentiality of the information to the same extent as is required in NAC 457.010 to 457.150, inclusive, and shall not disclose any of the information to a third person without the prior approval of the State Health Officer.
(Added to NAC by Bd. of Health, eff. 12-3-84; A 1-24-92)
NAC 457.110 Disclosure of information: Authorized recipients; verification of identity. (NRS 457.065, 457.240)
1. The State Health Officer or person employed in the registry shall not disclose the existence or nonexistence in the registry of a record concerning any patient or disclose other information about the patient except to:
(a) The physician who treated the patient;
(b) The health care facility where the patient was treated;
(c) A health care facility or a registry connected with that facility which has participated or is participating in treating the patient; or
(d) A qualified researcher in cancer.
2. If a request for information about a patient is made over the telephone by the physician who treated the patient or by a representative of the health care facility in which the patient was treated, and the caller is not known to the employee who receives the call at the registry, the employee must verify the identity of the caller in the manner described in NAC 457.130.
(Added to NAC by Bd. of Health, eff. 12-3-84; A 10-22-93)
NAC 457.120 Disclosure of information: Requirements of person seeking information. (NRS 457.065, 457.240) The State Health Officer or person employed in the registry may provide confidential medical information in the registry concerning a patient’s medical treatment for cancer with any health care facility, or registry connected with the facility which has participated or is participating in treating that patient’s illness if the person seeking the information:
1. Has been identified in the manner described in NAC 457.130;
2. Furnishes the employee of the registry with specific information, other than the patient’s name, which is sufficient to identify the patient without using his or her name; and
3. Gives assurances to the employee of the registry that the confidentiality of the information will be maintained to the same extent as is required in NAC 457.010 to 457.150, inclusive.
(Added to NAC by Bd. of Health, eff. 12-3-84; A 1-24-92; 10-22-93; R075-98, 11-18-98)
NAC 457.130 Verification of identity of person making request by telephone. (NRS 457.065, 457.240) If an employee in the registry receives a request to provide confidential information over the telephone pursuant to NAC 457.110 or 457.120, and the employee does not personally know the requester, the employee shall verify the identity of the requester by making a telephone call to the telephone number, listed in a directory or given by an operator, for the purported person or facility.
(Added to NAC by Bd. of Health, eff. 12-3-84)
NAC 457.140 Disclosure of information: Scientific research into cancer. (NRS 457.065, 457.240)
1. A person who desires to use the confidential records of individual patients or the statistical data of the registry for the purpose of scientific research into cancer must apply in writing to the State Health Officer. The applicant must:
(a) Set forth in the application:
(1) His or her qualifications as an epidemiologist, physician or employee of a bona fide program of research into cancer or other qualification for using confidential information and statistical data in the registry; and
(2) A description of the research project in which that information will be used.
(b) Sign a statement, on a form furnished by the State Health Officer or a designee thereof, in which the applicant agrees not to make any copies of the records, and to maintain the confidentiality of the information in the records in the manner required by NAC 457.010 to 457.150, inclusive.
(c) Agree to submit to the State Health Officer or the designee for review and approval any proposed publication which is based on or contains information obtained from the registry.
2. The State Health Officer or the designee must:
(a) Before a researcher is allowed access to information in the registry, make a written finding that he or she is qualified as a researcher and has a need for the information; and
(b) Before any material based on or containing information from the registry is published by the researcher, examine and give written approval for the proposed publication.
(Added to NAC by Bd. of Health, eff. 12-3-84; A 1-24-92; R075-98, 11-18-98)
NAC 457.150 Fees. (NRS 457.065, 457.250, 457.260) The State Health Officer shall charge and collect from:
1. A health care facility, a fee of $32 for each abstract prepared by the Health Division from the records of the health care facility and a fee of $8 for each abstract prepared by the health care facility from its own records.
2. A medical researcher or other person who obtains information from the registry, a fee of $35 or the actual cost of furnishing the information, whichever is larger.
(Added to NAC by Bd. of Health, eff. 12-3-84; A 8-31-89; 10-22-93; R075-98, 11-18-98)
OPERATION OF RADIATION MACHINE FOR MAMMOGRAPHY
General Provisions
NAC 457.200 Definitions. (NRS 457.065) As used in NAC 457.200 to 457.445, inclusive, unless the context otherwise requires, the words and terms defined in NAC 457.205 to 457.280, inclusive, have the meanings ascribed to them in those sections.
(Added to NAC by Bd. of Health, eff. 1-24-92; A 5-18-92; 7-7-94; R033-06, 6-28-2006; R184-08, 5-7-2010)
NAC 457.205 “Anti-scatter grid” defined. (NRS 457.065) “Anti-scatter grid” means a device that consists of a series of lead foil strips separated by spacers that are transparent to X rays, and which is used to remove scattered radiation during the performance of mammography.
(Added to NAC by Bd. of Health, eff. 1-24-92)
NAC 457.210 “Certificate” defined. (NRS 457.065) “Certificate” means a certificate for a machine or a mammographer’s certificate.
(Added to NAC by Bd. of Health, eff. 1-24-92)
NAC 457.215 “Certificate for a machine” defined. (NRS 457.065) “Certificate for a machine” means a certificate of authorization issued pursuant to NRS 457.184.
(Added to NAC by Bd. of Health, eff. 1-24-92)
NAC 457.220 “Device for compression” defined. (NRS 457.065) “Device for compression” means a device, made of a material transparent to X rays, that is used to compress the breast during mammography.
(Added to NAC by Bd. of Health, eff. 1-24-92)
NAC 457.225 “Facility for mammography” defined. (NRS 457.065) “Facility for mammography” means any place at which a machine is operated.
(Added to NAC by Bd. of Health, eff. 1-24-92)
NAC 457.230 “Half-value layer” defined. (NRS 457.065) “Half-value layer” has the meaning ascribed to it in NAC 459.450.
(Added to NAC by Bd. of Health, eff. 1-24-92)
NAC 457.235 “Health Division” defined. (NRS 457.065) “Health Division” means the Health Division of the Department of Health and Human Services.
(Added to NAC by Bd. of Health, eff. 1-24-92; A by R033-06, 6-28-2006)
NAC 457.240 “Image receptor” defined. (NRS 457.065) “Image receptor” has the meaning ascribed to it in NAC 459.454.
(Added to NAC by Bd. of Health, eff. 1-24-92)
NAC 457.245 “Machine” defined. (NRS 457.065) “Machine” means a radiation machine designed specifically for mammography.
(Added to NAC by Bd. of Health, eff. 1-24-92)
NAC 457.250 “Mammographer” defined. (NRS 457.065) “Mammographer” means a person who holds a valid mammographer’s certificate.
(Added to NAC by Bd. of Health, eff. 1-24-92)
NAC 457.255 “Mammographer’s certificate” defined. (NRS 457.065) “Mammographer’s certificate” means a certificate of authorization issued pursuant to NRS 457.183.
(Added to NAC by Bd. of Health, eff. 1-24-92)
NAC 457.260 “Operator of a facility” defined. (NRS 457.065) “Operator of a facility” means the owner or lessee of a machine or other responsible person to whom a certificate for a machine is issued.
(Added to NAC by Bd. of Health, eff. 1-24-92)
NAC 457.263 “Patients’ log” defined. (NRS 457.065) “Patients’ log” means the daily record of the patients who visit a facility for mammography which is prepared and maintained by the operator of the facility.
(Added to NAC by Bd. of Health, eff. 7-7-94)
NAC 457.265 “Responsible provider of care” defined. (NRS 457.065) “Responsible provider of care” means the provider of health care that will ensure that proper consultation or follow-up treatment, or both, for a patient will be provided if necessary.
(Added to NAC by Bd. of Health, eff. 5-18-92)
NAC 457.270 “Scattered radiation” defined. (NRS 457.065) “Scattered radiation” has the meaning ascribed to it in NAC 459.502.
(Added to NAC by Bd. of Health, eff. 1-24-92)
NAC 457.275 “Source-image receptor distance” defined. (NRS 457.065) “Source-image receptor distance” has the meaning ascribed to it in NAC 459.508.
(Added to NAC by Bd. of Health, eff. 1-24-92)
NAC 457.280 “Target” defined. (NRS 457.065) “Target” means the portion of the anode struck by electrons from the cathode in an X-ray tube.
(Added to NAC by Bd. of Health, eff. 1-24-92)
NAC 457.285 Adoption of certain publications and federal regulations by reference; review of revisions. (NRS 457.065)
1. The State Board of Health hereby adopts by reference the provisions of:
(a) The Mammography Quality Control Manual, American College of Radiology, Committee on Quality Assurance in Mammography, in the form most recently published, unless the Board gives notice that the most recent revision is not suitable for this State pursuant to subsection 2. A copy of this publication may be obtained at a cost of $57.50 from the American College of Radiology, P.O. Box 533, Annapolis Junction, Maryland 20701, at the Internet address http://www.acr.org or by telephone at (800) 227-7762.
(b) Report No. 149 - A Guide to Mammography and Other Breast Imaging Procedures, National Council on Radiation Protection. A copy of this publication may be obtained at a cost of $110 from NCRP Publications, 7910 Woodmont Avenue, Suite 400, Bethesda, Maryland 20814, at the Internet address http://www.ncrppublications.org or by telephone at (800) 229-2652 (extension 25).
(c) 21 C.F.R. Part 900, adopted pursuant to the Mammography Quality Standards Act, in the form most recently published, unless the Board gives notice that the most recent revision is not suitable for this State pursuant to subsection 2. A copy of this publication may be obtained by mail from the Superintendent of Documents, U.S. Government Printing Office, P.O. Box 979050, St. Louis, Missouri 63197-9000, or by toll-free telephone at (866) 512-1800, for the price of $13. This publication is also available, free of charge, from the Government Printing Office at the Internet address http://www.gpoaccess.gov/cfr/index.html.
2. The State Board of Health will review each revision of the publications adopted by reference pursuant to subsection 1 to ensure its suitability for the State. If the Board determines that the revision is not suitable for this State, it will hold a public hearing to review its determination and give notice of that hearing within 6 months after the date of the publication of the revision. If, after the hearing, the Board does not revise its determination, the Board will give notice that the revision is not suitable for this State within 30 days after the hearing. If the Board does not give such notice, the revision becomes part of the publication adopted by reference pursuant to subsection 1.
(Added to NAC by Bd. of Health, eff. 12-4-92; A 11-1-95; R033-06, 6-28-2006)
NAC 457.290 Granting of exemptions, exceptions or variances from requirements. (NRS 457.065) The Health Division may, upon application or on its own initiative, grant such exemptions, exceptions or variances from the requirements of NAC 457.200 to 457.445, inclusive, as it determines will not result in any undue hazard to public health and safety or property.
(Added to NAC by Bd. of Health, eff. 12-4-92; A by R033-06, 6-28-2006)
NAC 457.293 Procedure for review of actions taken by Health Division; appeals. (NRS 457.065)
1. A holder of a certificate or an applicant for a certificate who has reason to believe that an action taken by the Health Division pursuant to NAC 457.200 to 457.445, inclusive, is incorrect or based on inadequate knowledge may, within 10 business days after receiving notice of the action, request an informal discussion with the employee responsible for the action and the immediate supervisor of the employee.
2. If the informal discussion does not resolve the problem, the aggrieved person may, within 10 business days after the date scheduled for the informal discussion, submit a written request to the Bureau for an informal conference. The informal conference must be scheduled for a date, place and time mutually agreed upon by the aggrieved person and the Bureau, except that the informal conference must be held no later than 60 days after the date on which the Bureau received the request.
3. Except as otherwise provided in subsection 4, the determination of the Bureau resulting from the informal conference cannot be appealed and is the final remedy available to the aggrieved person.
4. An applicant for or holder of a certificate issued pursuant to NAC 457.200 to 457.445, inclusive, who is aggrieved by an action of the Health Division relating to the denial of an application for or renewal of such a certificate, the withdrawal, suspension or revocation of such a certificate or the assessment of an administrative fine may appeal that action in accordance with NAC 439.300 to 439.395, inclusive, after exhausting the informal procedures set forth in this section, except that the Bureau may waive the informal procedures, or any portion thereof, by giving written notice to the aggrieved person.
5. As used in this section, “Bureau” means the Bureau of Health Protection Services of the Health Division or its successor.
(Added to NAC by Bd. of Health, eff. 7-7-94; A 10-30-97; R075-98, 11-18-98; R033-06, 6-28-2006)
NAC 457.295 Fees for certificates. (NRS 439.150, 457.065, 457.183, 457.184) The Health Division shall charge and collect the following nonrefundable fees:
1. For the issuance or renewal of a certificate for a machine, $551.
2. For the issuance or renewal of a mammographer’s certificate, $88.
3. For the issuance or renewal of a certificate to provide training to mammographers pursuant to NAC 457.357, $100.
(Added to NAC by Bd. of Health, eff. 5-18-92; A 7-7-94; R148-03, 12-3-2003; R149-07, 1-30-2008)
NAC 457.297 Postponement of expiration of certificate for machine during review of application to renew. (NRS 457.065, 457.184) If an operator of a facility submits an application to renew his or her certificate for a machine and the appropriate fee to the Health Division at least 30 days before the expiration of the certificate, the certificate will not expire until the Health Division determines the status of the application.
(Added to NAC by Bd. of Health, eff. 7-7-94)
NAC 457.299 Requirements for approval of applications for certificates for machines and mammographer’s certificates. (NRS 457.065, 457.183, 457.184)
1. Except as otherwise provided in subsection 2, the Health Division shall approve an application for a certificate for a machine or an application for a mammographer’s certificate if it determines that:
(a) The applicant has the training and experience required to conduct mammography pursuant to the provisions of NAC 457.200 to 457.445, inclusive;
(b) The applicant has complied with any applicable requirements pursuant to NAC 457.200 to 457.445, inclusive; and
(c) In addition to the requirements of paragraphs (a) and (b), if the applicant is applying for a certificate for a machine:
(1) The equipment, facilities and procedures which the applicant proposes to use are adequate to minimize any danger to the public health or safety;
(2) A certificate for that machine is not currently issued to another owner, lessee or other responsible person; and
(3) The applicant is one person or corporate entity.
2. If the applicant held a certificate for a machine issued by the Health Division or by the appropriate agency in another jurisdiction and the certificate was revoked or the holder of the certificate was found to have committed a violation of a regulation relating to public health or safety which the Health Division determines to be significant, the Health Division shall not issue a certificate for a machine or a mammographer’s certificate to the applicant.
(Added to NAC by Bd. of Health, eff. 7-7-94; A by R033-06, 6-28-2006)
NAC 457.2995 Grounds for denial of application for renewal of certificate or withdrawal or suspension of certificate. (NRS 457.065) In addition to the grounds for disciplinary action set forth in chapter 457 of NRS, the Health Division may deny an application for renewal of a certificate or withdraw or suspend a certificate if the holder of the certificate, owner, lessee or other responsible person:
1. Violates the provisions of this chapter, chapter 457 of NRS, or any other applicable state or federal laws or regulations;
2. Permits an employee, who is under the supervision of the holder of the certificate, owner, lessee or other responsible person, to violate the provisions of this chapter, chapter 457 of NRS, or any other applicable state or federal laws or regulations;
3. Fails or refuses to cooperate with the Health Division during an investigation or inspection;
4. Fails or refuses to comply with a written request from the Health Division, the United States Food and Drug Administration or any applicable local or national accreditation body for records, reports or other materials;
5. Provides false or misleading or otherwise inaccurate information on an application for a certificate or for renewal of a certificate;
6. Has been disciplined by any applicable federal agency, local or national accreditation body or has otherwise been found by the Health Division to have committed unprofessional conduct, including, without limitation, a violation of the code of ethics or professional code of conduct of the federal agency or accreditation body; or
7. Held a certificate issued by the Health Division or by the appropriate agency in another jurisdiction and the certificate was withdrawn, revoked, terminated or suspended.
(Added to NAC by Bd. of Health by R184-08, eff. 5-7-2010)
Administrative Requirements
NAC 457.300 Quality assurance and control: General requirements. (NRS 457.065) The operator of a facility shall:
1. Establish and maintain a program of quality assurance in accordance with the provisions of 21 C.F.R. § 900.12 for each machine and all other equipment at the facility used for mammography.
2. Ensure that:
(a) The performance of the equipment is monitored;
(b) The results of monitoring are analyzed to determine if there are any problems requiring correction;
(c) The necessary corrective action is taken whenever the results of a test for quality assurance indicate that such action is required; and
(d) If necessary corrective action is taken, the action is taken before any mammography is performed on the patient.
3. Prepare and maintain a list which includes the name of each mammographer who is authorized to operate any machine which is under the operator’s control.
4. Except as otherwise provided in NAC 457.355, not allow a person who does not hold a mammographer’s certificate to operate a machine under the operator’s control.
5. If the facility for mammography has more than one machine, ensure that a unique machine identifier is included in the information which appears on the edge of the film as it is exposed.
6. Ensure that all quality assurance and quality control records are kept until:
(a) The next annual inspection has been completed and the Health Division has determined that the facility is compliant; or
(b) The tests for quality assurance have been performed two additional times at the required frequency and are within the applicable control limits,
Ê whichever is longer.
(Added to NAC by Bd. of Health, eff. 1-24-92; A 7-7-94; R033-06, 6-28-2006)
NAC 457.305 Quality assurance: Preparation and contents of manual; allocation of adequate time to perform duties. (NRS 457.065)
1. The operator of a facility shall prepare or cause to be prepared a manual for quality assurance for the facility. The manual must include:
(a) The name, position and a statement of the qualifications and duties of each person at the facility who is responsible for:
(1) Supervising the performance of mammography;
(2) Performing tests for quality assurance; or
(3) Repairing or maintaining machines.
Ê This information may be included in an attachment to the manual.
(b) Detailed provisions for a program of quality assurance for the image receptor and image processing systems of any system that is not a screen-film system at the facility. This program must be:
(1) Substantially the same as recommended by the manufacturer.
(2) Approved by the Health Division before it is put into effect.
(c) Detailed provisions for a program of quality assurance for the image receptor and film processing systems of any machine at the facility that uses a screen-film image receptor. These provisions must:
(1) Specify the tests for quality assurance that are required to be performed at the facility.
(2) Establish the frequency with which each such test is to be performed and the range of acceptable results for each test.
(3) Specify the procedure to be followed if the result of any test is not within the acceptable range.
Ê The program established pursuant to this paragraph must provide for the performance of tests for quality assurance in accordance with the requirements of NAC 457.420 to 457.445, inclusive.
(d) A copy of any form required to be used in connection with a test for quality assurance.
(e) Information concerning the cleaner recommended by the manufacturer of any screen used with a machine in the facility.
2. The operator of a facility shall ensure that adequate time is allocated for the performance of quality assurance duties.
(Added to NAC by Bd. of Health, eff. 1-24-92; A 7-7-94; R033-06, 6-28-2006)
NAC 457.310 Maintenance of records generally; contents and action on records of tests for quality assurance; maintenance of signature or initial cards; recording of number of films or projections used for patients. (NRS 457.065)
1. The operator of a facility shall ensure that records are maintained in the manner provided by NAC 457.200 to 457.445, inclusive. The records must be kept at the facility and must be reasonably accessible to any representative of the Health Division.
2. Each record of a test for quality assurance must set forth the date on which the test was performed and the name or initials of the person who performed the test.
3. A signature or initial card must be kept with the records maintained pursuant to subsection 1 to assist in identifying each person who signs or initials those records. The card must contain the full name in type or print of each person who signs or initials the records maintained at the facility and:
(a) If it is a signature card, the legal signature of each person who signs the records maintained at the facility; or
(b) If it is an initial card, the initials of each person who initials the records maintained at the facility.
4. The operator of a facility shall ensure that the number of films or projections used for each patient is recorded on the patients’ log.
5. Each record of a test for quality assurance must be made and evaluated immediately upon completion of the test. If the results are not within the control limits, corrective action must be completed, verified and documented in accordance with the provisions of 21 C.F.R. § 900.12.
(Added to NAC by Bd. of Health, eff. 1-24-92; A 7-7-94; R033-06, 6-28-2006)
NAC 457.312 Maintenance of records of patients; imaging requirements for digital mammography machine. (NRS 457.065)
1. Each facility for mammography shall maintain the records of a patient in accordance with the provisions of 21 C.F.R. § 900.12.
2. Each facility for mammography that has a digital mammography machine must be capable of printing or providing a hard copy image of primary interpretation quality to a patient, the representative of a patient or a physician.
(Added to NAC by Bd. of Health, eff. 7-7-94; A 11-1-95; R033-06, 6-28-2006)
NAC 457.313 Preliminary interpretation and reports of mammograms; standards for mammography records and reports. (NRS 457.065) The operator of a facility shall ensure that:
1. Each mammogram has a preliminary interpretation not later than 7 working days after the mammogram is performed;
2. For each mammogram that indicates cancerous or potentially cancerous tissue, the responsible provider of care of the patient is contacted at the time the preliminary interpretation is complete;
3. For each mammogram that otherwise indicates the need for additional workup or evaluation which prevents the written report from being sent to the responsible provider of care of the patient within 7 working days, the responsible provider of care is contacted at the time the preliminary interpretation is complete; and
4. Mammography records and reports comply with the provisions of 21 C.F.R. § 900.12.
(Added to NAC by Bd. of Health, eff. 7-7-94; A by R033-06, 6-28-2006)
NAC 457.315 Maintenance of record of repair or calibration of equipment used to perform test for quality assurance. (NRS 457.065) The operator of a facility shall ensure that a record is made of any repair or calibration of the equipment used to perform a test for quality assurance. The record must be made and maintained in accordance with the provisions of 21 C.F.R. § 900.12.
(Added to NAC by Bd. of Health, eff. 1-24-92; A by R033-06, 6-28-2006)
NAC 457.320 Maintenance of record documenting maintenance of equipment used for mammography. (NRS 457.065) At each facility for mammography, a record must be maintained documenting the maintenance of all equipment used for mammography at the facility in accordance with the provisions of 21 C.F.R. § 900.12.
(Added to NAC by Bd. of Health, eff. 1-24-92; A 7-7-94; R033-06, 6-28-2006)
NAC 457.325 Documentation required for imaging processing systems and printing equipment. (NRS 457.065) The operator of a facility shall document all maintenance, quality assurance and quality control of the imaging processing system of each machine used at the facility for mammography and the printing equipment used at the facility for mammography in accordance with the provisions of 21 C.F.R. § 900.12.
(Added to NAC by Bd. of Health, eff. 1-24-92; A 7-7-94; R033-06, 6-28-2006)
NAC 457.330 Plotting and evaluation of certain information on control chart; action required when information is not within applicable control limits. (NRS 457.065)
1. The following information must be plotted and evaluated on a control chart in accordance with the provisions of 21 C.F.R. § 900.12:
(a) The values obtained from the daily exposure and processing of sensitometric strips.
(b) The exposure time or mAs and the number of objects visible in the image of the breast phantom in each test of image quality.
(c) A description of any change in operating conditions made as the result of a test for quality assurance.
(d) The operating levels and control limits for each test for quality assurance performed.
2. If the information obtained pursuant to subsection 1 is not within the applicable control limits, corrective action must be completed and verified before any patients are examined or films are processed.
(Added to NAC by Bd. of Health, eff. 1-24-92; A by R033-06, 6-28-2006)
NAC 457.335 Inspection of facility and certain records. (NRS 457.065) The operator of a facility shall:
1. Allow an employee or other representative of the Health Division to inspect the facility at any reasonable time.
2. Make available to an employee or other representative of the Health Division any record required to be maintained pursuant to NAC 457.200 to 457.445, inclusive.
3. Make available to an employee or other representative of the Health Division any record required to demonstrate compliance with applicable laws and regulations, including, without limitation, the work schedules of persons who are employed or retained by the facility for mammography and the records indicating the persons who worked each day that mammography was performed at the facility.
(Added to NAC by Bd. of Health, eff. 1-24-92; A by R033-06, 6-28-2006)
Personnel
NAC 457.340 Physician who supervises operation of machine: Preparation, review and updating of manual of procedures; compliance with standards; notification of violation of chapter. (NRS 457.065) The physician who supervises the operation of a machine at a facility for mammography shall:
1. Prepare a manual of procedures for the operation of the machine.
2. Review and update the manual as required, or at least every 12 months. A record of the review and update must be:
(a) Prepared and kept at the facility.
(b) Signed and dated by the physician.
3. Comply with the standards for protection against radiation set forth in NAC 459.320 to 459.664, inclusive, and the requirements of NAC 459.780 to 459.794, inclusive.
4. Notify the Health Division of any violation of this chapter or chapter 459 of NAC within 30 days after the date on which the physician discovers the violation.
(Added to NAC by Bd. of Health, eff. 1-24-92; A 5-18-92; 7-7-94; R033-06, 6-28-2006; R184-08, 5-7-2010)
NAC 457.345 Interpreter of mammograms: Prerequisites to certification of machine. (NRS 457.065, 457.184)
1. A person who is employed or retained by a facility for mammography to interpret mammograms must comply with the requirements of this section as a prerequisite to the issuance or renewal of any certificate for a machine located at the facility.
2. The person:
(a) Must be a physician licensed pursuant to chapter 630 or 633 of NRS; and
(b) Must satisfy the qualifications for an interpreting physician set forth in 21 C.F.R. § 900.12(a)(1).
(Added to NAC by Bd. of Health, eff. 1-24-92; A 7-7-94; 11-1-95; R033-06, 6-28-2006)
NAC 457.347 Interpreter of mammograms: Temporary employment at other facilities. (NRS 457.065)
1. A person who is employed or retained by a facility for mammography to interpret mammograms pursuant to NAC 457.345 may interpret mammograms at another facility for mammography for not more than 60 days each year if:
(a) The person has obtained written authorization from the operator of the facility where he or she will be temporarily interpreting mammograms; and
(b) The facility where the person will be temporarily interpreting mammograms maintains a copy of the current certificate for a machine issued by the Health Division to the facility where the person is regularly employed or retained that identifies the person who will interpret mammograms at that facility.
2. The facility where a person is temporarily interpreting mammograms must:
(a) Verify that the person is qualified as an interpreting physician at the start of each period of temporary employment; and
(b) Maintain documentation which demonstrates that the person is qualified as an interpreting physician.
3. The facility where a person is temporarily interpreting mammograms must retain a copy of the written authorization and the certificate described in subsection 1 for at least 2 years after the person ceases to interpret mammograms at that facility.
(Added to NAC by Bd. of Health, eff. 7-7-94; A 11-1-95; R033-06, 6-28-2006)
NAC 457.350 Mammographer: Requirements for certification. (NRS 457.065, 457.183)
1. A person who desires to work as a mammographer in Nevada must be certified in general radiography by the American Registry of Radiologic Technologists, or by another organization approved by the Health Division, and must hold a valid mammographer’s certificate.
2. A person who desires to work as a mammographer in Nevada may obtain a mammographer’s certificate by applying to the Radiological Health Section of the Bureau of Health Protection Services of the Health Division. An applicant must:
(a) Satisfy the requirements of NRS 457.183; and
(b) Provide documentation satisfactory to the Health Division that the applicant meets the requirements of 21 C.F.R. § 900.12(a)(2).
(Added to NAC by Bd. of Health, eff. 1-24-92; A 7-7-94; 11-1-95; R033-06, 6-28-2006)
NAC 457.355 Program of instruction in mammography: General requirements. (NRS 457.065)
1. A program of instruction in mammography that is undertaken to meet the requirements for issuance of a mammographer’s certificate must be approved by the Health Division and comply with the provisions of this section.
2. The program must include instruction in:
(a) The anatomy and physiology of the female breast, with instruction in the following topics:
(1) Mammary glands.
(2) External anatomy.
(3) Subdivision for localization.
(4) Retromammary space.
(5) Central portion.
(6) Cooper’s ligament.
(7) Vessels, nerves and lymphatics.
(8) Breast tissue.
(b) The classification of breast tissue.
(c) The epidemiology of the breast, methods of detecting breast cancer and sources of information relating to epidemiology of the breast.
(d) The effects of adjustments relating to the setting of the exposure timer, current and voltage.
(e) The positioning of the breast for mammography, with instruction in:
(1) The following positions:
(I) Craniocaudal.
(II) Medial lateral oblique.
(III) Axillary.
(IV) Lateral.
(V) Mediolateral.
(VI) Lateromedial.
(VII) Exaggerated angled craniocaudal.
(VIII) Craniocaudal without compression.
(IX) “Cleopatra” or 30 degrees oblique.
(X) Coned or spot compression.
(XI) Lateral oblique.
(XII) “Coathanger” or displaced.
(XIII) Modified craniocaudal.
(XIV) Modified mediolateral oblique.
(XV) Other positions as required.
(2) Magnification.
(3) Errors in positioning.
(4) Special techniques for mammography of the postoperative breast and the augmented breast.
(5) Special radiographic techniques for breast localization and specimen radiography.
(f) The evaluation and critique of mammograms, with instruction in the following topics:
(1) Criteria for determining the quality of images.
(2) The scanning of images.
(3) The detection of pathology.
(4) Benign and malignant lesions.
(5) Mass lesion borders.
(6) Calcifications.
(g) The biological effects of radiation and protection from radiation.
(h) The techniques and methods of quality assurance.
(i) The methods of breast imaging other than mammography.
3. A program of instruction in mammography must provide to each person who is enrolled in the program at least 40 contact hours of training specific to mammography.
4. A person who is enrolled in a program of instruction in mammography pursuant to this section shall not operate a machine for mammography unless a mammographer is present while that person operates the machine and is able to stop the procedure for performing the mammogram at any time.
(Added to NAC by Bd. of Health, eff. 1-24-92; A 7-7-94; R033-06, 6-28-2006)
NAC 457.357 Program of instruction in mammography: Certification of person to provide training. (NRS 457.065)
1. A person who wishes to be certified to provide training to mammographers pursuant to NAC 457.355 must submit an application to the Health Division which is accompanied by the fee set forth in NAC 457.295 and evidence of his or her qualifications.
2. A person who wishes to renew his or her certificate to provide training to mammographers pursuant to NAC 457.355 must submit annually an application and the fee for renewal set forth in NAC 457.295 to the Health Division at least 30 days before the expiration of the certificate.
(Added to NAC by Bd. of Health, eff. 7-7-94)
NAC 457.360 Mammographer: Duties. (NRS 457.065) A mammographer shall:
1. Perform each of the mammographer’s assigned duties correctly and conscientiously.
2. Stand behind a protective barrier whenever X-rays are being produced during mammography.
3. Wear on his or her torso the monitoring device assigned to him or her during all working hours.
4. Use optimum techniques of exposure.
5. Use optimum techniques for the processing of images.
6. Follow the standing orders and policies for repeated exposures established for the facility at which he or she is employed.
7. Correctly determine what views are required, based on a written protocol, and position patients properly.
8. Limit the size of the X-ray field to the area of clinical interest.
9. Instruct each patient clearly to avoid movement by the patient.
10. Use appropriate compression with due consideration to the particular circumstances of each case.
11. Handle films, cassettes for holding film and other image receptors for mammography carefully to eliminate artifacts.
12. Post his or her mammographer’s certificate where it can be seen by patients.
13. Record his or her full name on the record of each patient.
14. Ensure that his or her name or initials are included in the information which appears on the edge of each film as it is exposed.
15. Sign or initial the patients’ log to indicate each patient upon whom the mammographer performed mammography.
16. Indicate, in the space located after his or her signature or initials in the patients’ log, the number of films used for each patient.
17. Comply with the standards for protection against radiation set forth in NAC 459.320 to 459.664, inclusive, and the requirements of NAC 459.780 to 459.794, inclusive.
18. Notify the Health Division of any violation of this chapter or chapter 459 of NAC within 30 days after the date on which the mammographer discovers the violation.
(Added to NAC by Bd. of Health, eff. 1-24-92; A 7-7-94; R033-06, 6-28-2006; R184-08, 5-7-2010)
NAC 457.365 Mammographer: Prohibited acts. (NRS 457.065) A mammographer shall not:
1. Perform mammography except under the supervision of a physician who is licensed pursuant to chapter 630 or 633 of NRS and meets the requirements of NAC 457.345.
2. Except as otherwise authorized by the Health Division pursuant to NAC 459.554, perform mammography without a prescription or order from the patient’s referring or responsible provider of care. The mammographer shall post a copy of the authorization of the Health Division in a conspicuous place near the machine.
3. Use any machine unless there have been established for the facility for mammography:
(a) Written standing orders concerning the number and type of views to be taken of each patient; and
(b) A policy governing the repetition of exposures in any case where the image obtained from the first exposure is inadequate.
4. Make a diagnosis based on any mammogram.
5. Operate a machine without having been trained to operate that machine safely and effectively.
6. Report a diagnosis to a patient, except that the mammographer may provide the patient with the mammogram or a copy of the report by the physician who interprets the mammogram, or both, without any comment to the patient concerning the contents of the mammogram or report.
7. Touch the breast of any patient, except as required to position the patient for mammography or to obtain clinical information to assist the physician who supervises the operation of the machine in arriving at a diagnosis.
8. Routinely hold the patient or the image receptor during an exposure.
(Added to NAC by Bd. of Health, eff. 1-24-92; A 5-18-92; 7-7-94; R033-06, 6-28-2006)
NAC 457.370 Mammographer: Renewal of certificate; continuing education. (NRS 457.065. 457.183)
1. A mammographer who desires to renew his or her mammographer’s certificate must submit to the Health Division an application for renewal. The application must:
(a) Be received by the Division not less than 30 days before the expiration of the certificate; and
(b) Include documentation which establishes that the mammographer possesses a current credential in general radiography.
2. Each mammographer must, as a condition of renewal, furnish to the Health Division evidence that he or she has received not less than 15 hours of continuing medical education in mammography during the immediately preceding 36 months. Continuing education received in compliance with the provisions of this subsection must be approved by the Health Division or a national or regional organization approved by the Health Division, including, without limitation, the American College of Radiology or the American Society of Radiologic Technologists. Evidence of continuing education must include a certificate of completion issued by the sponsoring organization. The certificate must include:
(a) The name of the person;
(b) The number of hours of credit relating to mammography earned by the person;
(c) The dates on which continuing education was received; and
(d) The name of the representative of the sponsoring organization who issued the certificate.
3. The Health Division will not recognize a mammographer’s certification by the American Registry of Radiologic Technologists, or the equivalent, obtained after receipt of his or her mammographer’s certificate, as meeting the continuing education requirements of subsection 2.
4. Continuing education hours earned through providing instruction or attending a specific course may be counted only once toward the 15 hours of continuing medical education in mammography required by subsection 2, even if the course is taught or attended more than once during the 36-month period.
(Added to NAC by Bd. of Health, eff. 1-24-92; A 7-7-94; 11-1-95; R033-06, 6-28-2006)
Equipment
NAC 457.373 Compliance with certain federal requirements. (NRS 457.065) All equipment used for mammography, regardless of whether the equipment is fixed or mobile, must comply with the requirements of 21 C.F.R. § 900.12.
(Added to NAC by Bd. of Health, eff. 1-24-92; A by R033-06, 6-28-2006)—(Substituted in revision for NAC 457.415)
NAC 457.375 Standards for and approval of machine. (NRS 457.065) A machine, including its X-ray system and its image receptor system and its components, must meet the requirements set forth in 21 C.F.R. § 900.12 and must be approved for mammography by the United States Food and Drug Administration.
(Added to NAC by Bd. of Health, eff. 1-24-92; A 7-7-94; 11-1-95; R033-06, 6-28-2006)
NAC 457.390 Required equipment, intensifying screens and film. (NRS 457.065)
1. The operator of a facility shall ensure that the following equipment is maintained at the facility and is properly calibrated and in good working order:
(a) A breast phantom capable of depicting:
(1) A mass having a width of 0.5 millimeter or less;
(2) A calcification having a diameter of 0.24 millimeter or less; and
(3) Fibers of nylon or similar material having a width of 0.75 millimeter or less.
(b) For a facility using screen-film imaging:
(1) A wire mesh contact tool designed for use in mammography with a 40 mesh copper screen.
(2) A thermometer accurate to ± 0.5°F. A thermometer containing mercury must not be used.
(3) A sensitometer that generates blue or green light, as appropriate to the type of film used at the facility, with a reproducibility of ± 0.04 log exposure.
(4) A densitometer accurate to ± 0.02 optical density and having a range of 0.00 to 3.5 optical density.
2. A facility for mammography must use intensifying screens that have been designated by the screen manufacturer as appropriate for mammography and must use film that is matched to the spectral output of the screen as specified by the manufacturer.
(Added to NAC by Bd. of Health, eff. 1-24-92; A by R033-06, 6-28-2006)
NAC 457.395 Darkroom: Prohibited activities; cleanliness; safelight. (NRS 457.065)
1. A person shall not smoke or eat in the darkroom of a facility for mammography.
2. The darkroom must be kept reasonably free of dust.
3. Countertops and the feed tray of any film processing equipment must be cleaned daily before any film is handled or processed.
4. Hands must be clean and dry when touching a film.
5. A darkroom safelight must be equipped with an appropriate combination of filter and bulb. Information concerning the required combination must be prominently posted in the darkroom or the area surrounding the darkroom.
(Added to NAC by Bd. of Health, eff. 1-24-92; A by R033-06, 6-28-2006)
Tests for Quality Assurance
NAC 457.400 Tests required after certain repairs or replacements of components. (NRS 457.065) Tests for quality assurance must be performed pursuant to 21 C.F.R. § 900.12 whenever any component of the X-ray machine is repaired or replaced, and before the machine is used for mammography if the repair or replacement affects:
1. Image quality.
2. The accuracy or consistency of operation of the exposure timer or automatic exposure control.
3. Milliampere-seconds linearity.
4. The accuracy of the kilovolt peak indicated by the machine.
5. The skin entrance exposure or glandular tissue dose.
6. Focal spot size.
7. Half-value layer.
(Added to NAC by Bd. of Health, eff. 1-24-92; A 11-1-95; R033-06, 6-28-2006)
NAC 457.410 Qualification of persons to perform tests. (NRS 457.065) Tests for quality assurance must be performed by a person who meets the qualifications set forth in 21 C.F.R. § 900.12(a).
(Added to NAC by Bd. of Health, eff. 1-24-92; A 7-7-94; R033-06, 6-28-2006)
NAC 457.420 Tests of film processing equipment; action on results. (NRS 457.065)
1. A test of film processing equipment used for mammography must be performed pursuant to 21 C.F.R. § 900.12 for each day that the equipment is in operation and before any clinical films are processed.
2. The results of the tests performed pursuant to subsection 1 must be recorded, plotted on a control chart, evaluated and acted upon immediately after the test is completed and before any clinical films are processed. If the results are not within the applicable control limits, corrective action must be completed and verified as successful before any clinical films are processed.
(Added to NAC by Bd. of Health, eff. 1-24-92; A by R033-06, 6-28-2006)
NAC 457.425 Tests of image quality. (NRS 457.065) The operator of a facility shall ensure that tests of image quality are performed using a breast phantom pursuant to 21 C.F.R. § 900.12.
(Added to NAC by Bd. of Health, eff. 1-24-92; A 7-7-94; 11-1-95; R033-06, 6-28-2006)
NAC 457.435 Analyses of rejected mammograms. (NRS 457.065) The operator of a facility shall ensure that an analysis of all rejected mammograms is performed pursuant to the provisions of 21 C.F.R. § 900.12.
(Added to NAC by Bd. of Health, eff. 1-24-92; A 7-7-94; R033-06, 6-28-2006)
NAC 457.445 Verification of safe operating condition of machine; record of findings. (NRS 457.065)
1. Before any machine is placed into service and at least annually thereafter, the machine must be examined to verify that it is in safe operating condition. An examination must also be made after a major repair to a machine.
2. The examination required by subsection 1 must be made by a medical physicist.
3. The person making the examination shall make a written record of his or her findings and submit the record to the operator of the facility within 30 days after the examination.
4. If the operator of the facility does not receive the written record within the period prescribed in subsection 3, the operator shall remove the machine from service until he or she receives the record.
(Added to NAC by Bd. of Health, eff. 1-24-92; A 7-7-94; R033-06, 6-28-2006)
CANCER DRUG DONATION PROGRAM
General Provisions
NAC 457.500 Definitions. (NRS 457.480) As used in NAC 457.500 to 457.595, inclusive, unless the context otherwise requires, the words and terms defined in NAC 457.505 to 457.545, inclusive, have the meanings ascribed to them in those sections.
(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)
NAC 457.505 “Board” defined. (NRS 457.480) “Board” means the State Board of Pharmacy.
(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)
NAC 457.510 “Cancer drug” defined. (NRS 457.480) “Cancer drug” has the meaning ascribed to it in NRS 457.410.
(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)
NAC 457.515 “Dispense” defined. (NRS 457.480) “Dispense” has the meaning ascribed to it in NRS 639.0065.
(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)
NAC 457.520 “Distribute” defined. (NRS 457.480) “Distribute” means to deliver, other than by administering or dispensing, a cancer drug.
(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)
NAC 457.525 “Health clinic” defined. (NRS 457.480) “Health clinic” means a facility which provides, as a regular course of practice, medical services and goods to persons with cancer and is operated by a physician who is licensed pursuant to chapter 630 or 633 of NRS.
(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)
NAC 457.530 “Medical facility” defined. (NRS 457.480) “Medical facility” has the meaning ascribed to it in NRS 449.0151.
(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)
NAC 457.535 “Pharmacy” defined. (NRS 457.480) “Pharmacy” has the meaning ascribed to it in NRS 639.012.
(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)
NAC 457.540 “Program” defined. (NRS 457.480) “Program” has the meaning ascribed to it in NRS 457.430.
(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)
NAC 457.545 “Provider of health care” defined. (NRS 457.480) “Provider of health care” has the meaning ascribed to it in NRS 629.031.
(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)
Participation of Persons in Program
NAC 457.555 Eligibility for participation in Program to receive cancer drug. (NRS 457.480) A person who wishes to receive a cancer drug dispensed pursuant to the Program must be:
1. A resident of this State;
2. Diagnosed as having cancer; and
3. Approved to participate in the Program pursuant to NAC 457.560.
(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)
NAC 457.560 Submission of application to participate; written notice of approval or denial by Board. (NRS 457.480)
1. A person who wishes to participate in the Program must submit an application to the Board on a form prescribed by the Board.
2. The Board will review the application and determine if the person is qualified to participate in the Program.
3. If the Board approves a person to participate in the Program, the Board will provide written notice of its approval of the application to the person not later than 30 days after its decision.
4. If the Board denies a person from participating in the Program, the Board will provide written notice of its denial of the application to the person not later than 30 days after its decision.
(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)
Participation of Pharmacies, Medical Facilities, Health Clinics and Providers of Health Care in Program
NAC 457.565 Eligibility for participation in Program. (NRS 457.480) To be eligible to participate in the Program:
1. A pharmacy must be:
(a) Licensed in this State; and
(b) Approved to participate in the Program pursuant to NAC 457.570.
2. A medical facility must:
(a) Be licensed in this State;
(b) Provide, as a regular course of practice, medical services and goods to persons with cancer; and
(c) Be approved to participate in the Program pursuant to NAC 457.570.
3. A health clinic must be approved to participate in the Program pursuant to NAC 457.570.
4. A provider of health care must:
(a) Be licensed in this State;
(b) Provide, as a regular course of practice, medical services and goods to persons with cancer; and
(c) Be approved to participate in the Program pursuant to NAC 457.570.
(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)
NAC 457.570 Submission of application to participate; written notice of approval or denial by Board. (NRS 457.480)
1. A pharmacy, medical facility, health clinic or provider of health care that wishes to participate in the Program must submit an application to the Board on a form prescribed by the Board.
2. The Board will review the application and determine if the pharmacy, medical facility, health clinic or provider of health care is qualified to participate in the Program.
3. If the Board approves a pharmacy, medical facility, health clinic or provider of health care for participation in the Program, the Board will provide written notice of its approval of the application to the pharmacy, medical facility, health clinic or provider of health care not later than 30 days after its decision.
4. If the Board denies a pharmacy, medical facility, health clinic or provider of health care from participating in the Program, the Board will provide written notice of its denial of the application to the pharmacy, medical facility, health clinic or provider of health care not later than 30 days after its decision.
(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)
NAC 457.575 Compliance with federal and state laws and regulations required. (NRS 457.480) A pharmacy, medical facility, health clinic or provider of health care that participates in the Program must comply with all applicable federal and state laws and regulations when accepting, distributing and dispensing a cancer drug pursuant to the Program.
(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)
Administration of Program; Fees
NAC 457.580 Board to establish and maintain registry of participants; notification to Board of certain changes in information or status. (NRS 457.480)
1. The Board will establish and maintain a registry of pharmacies, medical facilities, health clinics and providers of health care that participate in the Program, which must include, without limitation, the name, address and telephone number of each pharmacy, medical facility, health clinic and provider of health care that is authorized by the Board to participate in the Program.
2. A pharmacy, medical facility, health clinic or provider of health care must notify the Board, on a form prescribed by the Board, if the pharmacy, medical facility, health clinic or provider of health care:
(a) Has a change in its name, address or telephone number; or
(b) No longer wishes to participate in the Program.
3. The Board will post the registry on the Internet website maintained by the Board.
(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)
NAC 457.585 Donating, dispensing and storage of cancer drugs. (NRS 457.480)
1. Except as otherwise required for the storage of cancer drugs pursuant to subsection 3, a pharmacy, medical facility, health clinic or provider of health care shall not limit the amount of cancer drugs that a person may donate to the Program.
2. In addition to the requirements of NRS 457.460, a pharmacist may dispense a cancer drug to a person who is participating in the Program if:
(a) The pharmacist has inspected the packaging of the cancer drug to determine if the cancer drug meets the requirements of subsection 4 of NRS 457.450;
(b) The person requesting the cancer drug presents to the pharmacist the written notice of approval from the Board which states that the person is approved to participate in the Program; and
(c) The person requesting the cancer drug presents to the pharmacist a prescription written by a person who is authorized to write prescriptions.
3. A pharmacy, medical facility, health clinic or provider of health care shall store a cancer drug that is donated to the Program:
(a) Pursuant to the recommendations of the manufacturer of the cancer drug concerning the storage conditions;
(b) Separately from all other drugs; and
(c) In a locked storage area.
4. If a cancer drug that is donated to the Program expires before it is dispensed, the pharmacy, medical facility, health clinic or provider of health care shall destroy the cancer drug.
(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)
NAC 457.587 Restrictions on donated cancer drugs. (NRS 457.480)
1. In addition to the requirements of NRS 457.450, a cancer drug that is donated to the Program:
(a) Must not be a controlled substance.
(b) Must not be a compounded drug product.
(c) Must not be dispensed by a pharmacist if the pharmacist suspects that the cancer drug is adulterated or misbranded.
(d) Must not be dispensed by a pharmacist if, in the professional judgment of the pharmacist, there is a reasonable concern relating to the safety or efficacy of the cancer drug.
(e) Must not require refrigeration or freezing or other temperature requirements that are not a controlled room temperature.
(f) Must not be a cancer drug for which a program of restrictive distribution has been established by the manufacturer of the cancer drug.
(g) Must not be a cancer drug for which an ongoing clinical trial or study is being conducted.
(h) Must be a cancer drug that was dispensed pursuant to an original prescription by a pharmacy licensed pursuant to chapter 639 of NRS.
2. As used in this section, “program of restrictive distribution” means a program that is developed in collaboration with the United States Food and Drug Administration by a manufacturer of a drug to reduce the risks associated with that drug by limiting the persons who can prescribe the drug and who can receive the drug.
(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)
NAC 457.590 Maintenance of records by pharmacy, medical facility, health clinic or provider of health care that participates in Program. (NRS 457.480)
1. In addition to the requirements of NRS 639.2801 and NAC 639.708, a pharmacy, medical facility, health clinic or provider of health care that participates in the Program shall maintain records for a cancer drug that is donated to the Program. The records must include, without limitation:
(a) The date the pharmacy, medical facility, health clinic or provider of health care received the cancer drug;
(b) The date the cancer drug was dispensed pursuant to the original prescription;
(c) The original prescription number of the cancer drug;
(d) The name of the cancer drug;
(e) The dosage of the cancer drug;
(f) The quantity of the cancer drug that is donated;
(g) The date of expiration of the cancer drug;
(h) The name, address and telephone number of the person who originally dispensed the cancer drug;
(i) The name, address and telephone number of the person who is donating the cancer drug; and
(j) The lot number of the cancer drug.
2. A pharmacy, medical facility, health clinic or provider of health care shall maintain records of a cancer drug that is distributed to another pharmacy, medical facility, health clinic or provider of health care that is participating in the Program. The records must include, without limitation:
(a) The information required pursuant to subsection 1;
(b) The name, address and telephone number of the pharmacy, medical facility, health clinic or provider of health care that is distributing the cancer drug;
(c) The quantity of the cancer drug that is being distributed; and
(d) The name and address of the pharmacy, medical facility, health clinic or provider of health care to which the cancer drug is distributed.
(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)
NAC 457.595 Handling fee. (NRS 457.450, 457.480) A pharmacy, medical facility, health clinic or provider of health care may charge a handling fee of not more than $10 for distributing or dispensing a cancer drug that is donated to the Program.
(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)