[Rev. 9/25/2018 1:56:17 PM]
[NAC-457 Revised Date: 9-18]
REPORTING AND ANALYZING INFORMATION ON CANCER AND OTHER NEOPLASMS
457.010 Definitions.
457.015 Adoption of publications by reference; availability; review of revisions by Chief Medical Officer and State Board of Health.
457.030 Severability.
457.040 Types of neoplasms to be reported.
457.045 Exceptions to reporting requirement.
457.050 Abstracting and submitting of information by provider of health care, health care facility and certain other facilities; deadlines for submission; standards for abstracting information; waiver of electronic submission.
457.052 Reporting of information by provider of health care, health care facility and certain other facilities: Required contents; request for variance from requirement.
457.053 Reporting of information by medical laboratory.
457.057 Reporting of information by provider of health care.
457.060 Confidentiality of information.
457.070 Procedures for maintaining confidentiality of information.
457.080 Procedures for taking confidential information outside offices of Division.
457.090 Mailing of confidential information; list of persons authorized to receive confidential information.
457.100 Persons with whom Chief Medical 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.
457.145 Administrative penalty for violation; appeal; single report authorized for company that operates multiple facilities; imposition of administrative penalty upon company rather than facility.
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.
457.223 “Division” defined.
457.225 “Facility for mammography” defined.
457.230 “Half-value layer” 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 Division; appeals.
457.295 Fees for certificates; refund of portion of fees paid in error.
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; statement regarding breast density and other information to be provided to patient.
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.
REPORTING AND ANALYZING INFORMATION ON CANCER AND OTHER NEOPLASMS
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. “Division” means the Division of Public and Behavioral Health of the Department of Health and Human Services.
3. “Health care facility” has the meaning ascribed to it in NRS 457.020.
4. “Medical laboratory” has the meaning ascribed to it in NRS 652.060.
5. “Provider of health care” has the meaning ascribed to it in NRS 629.031.
6. “Registry” means the office in which the Chief Medical Officer conducts the program for reporting information on cancer and other neoplasms 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; R057-16, 5-16-2018)
NAC 457.015 Adoption of publications by reference; availability; review of revisions by Chief Medical Officer and State Board of Health. (NRS 457.065, 457.240)
1. The State Board of Health hereby adopts by reference the most current version of:
(a) The following volumes in the Standards for Cancer Registries published by the North American Association of Central Cancer Registries:
(1) Volume I, Data Exchange Standards and Record Descriptions;
(2) Volume II, Data Standards and Data Dictionary;
(3) Volume III, Standards for Completeness, Quality, Analysis, Management, Security, and Confidentiality of Data;
(4) Volume IV, Standard Data EDITS; and
(5) Volume V, Pathology Laboratory Electronic Reporting.
Ê A copy of each volume adopted by reference may be obtained, free of charge, from the North American Association of Central Cancer Registries at the Internet address https://www.naaccr.org.
(b) The International Classification of Diseases for Oncology, published by the World Health Organization. A copy of this publication may be obtained, free of charge, from the World Health Organization at the Internet address http://codes.iarc.fr/usingicdo.php.
(c) The Facility Oncology Registry Data Standards (FORDS), published by the Commission on Cancer of the American College of Surgeons. A copy of this publication may be obtained, free of charge, from the American College of Surgeons at the Internet address https://www.facs.org/quality-programs/cancer/ncdb/registrymanuals/cocmanuals.
2. If a publication adopted by reference in subsection 1 is revised, the Chief Medical Officer shall review the revision to determine its suitability for this State. If the Chief Medical Officer determines that the revision is not suitable for this State, the Chief Medical Officer shall file an objection to the revision with the State Board of Health within 30 days after the standards are revised. If the Chief Medical Officer does not file such an objection, the revision becomes part of the publication adopted by reference pursuant to subsection 1. 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 by R057-16, eff. 5-16-2018)
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 neoplasms to be reported. (NRS 457.065, 457.240) Except as otherwise provided in NAC 457.045, the types of neoplasms which must be reported pursuant to NRS 457.240 are as follows:
1. Any neoplasm that is listed in the International Classification of Diseases for Oncology, as adopted by reference in NAC 457.015, with a behavior code of in situ or malignant; and
2. Any solid tumor of the brain or central nervous system, including, without limitation, the meninges and intracranial endocrine structures, that is listed in the International Classification of Diseases for Oncology, as adopted by reference in NAC 457.015, with a behavior code of benign, uncertain malignant potential, in situ or malignant.
(Added to NAC by Bd. of Health, eff. 12-3-84; A by R075-98, 11-18-98; R057-16, 5-16-2018)
NAC 457.045 Exceptions to reporting requirement. (NRS 457.065, 457.240) Carcinoma in situ of the cervix uteri and cervical intraepithelial neoplasia, basal and squamous cell carcinomas of the skin and prostatic intraepithelial neoplasia 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; A by R057-16, 5-16-2018)
NAC 457.050 Abstracting and submitting of information by provider of health care, health care facility and certain other facilities; deadlines for submission; standards for abstracting information; waiver of electronic submission. (NRS 457.065, 457.240)
1. Except as otherwise provided in NAC 457.052, each provider of health care who is required to report information on cases of cancer and other neoplasms pursuant to NRS 457.230 and each health care facility and other facility that provides screening, diagnostic or therapeutic services to patients with respect to cancer and other neoplasms shall provide to the Chief Medical Officer information concerning such neoplasms by:
(a) Abstracting, at a minimum, the information described in NAC 457.052 on a form prescribed by the Chief Medical Officer or a designee thereof; and
(b) Except as otherwise provided in subsection 7, submitting that information on a quarterly basis using an electronic means approved by the Chief Medical Officer or the designee.
2. Each:
(a) Provider of health care described in subsection 1 shall provide the information to the Chief Medical Officer required pursuant to subsection 1:
(1) For any initial diagnosis made or treatment initiated for cancer or other neoplasms in the first quarter of a calendar year, on or before June 30 of the same calendar year;
(2) For any initial diagnosis made or treatment initiated for cancer or other neoplasms in the second quarter of a calendar year, on or before September 30 of the same calendar year;
(3) For any initial diagnosis made or treatment initiated for cancer or other neoplasms in the third quarter of a calendar year, on or before December 30 of the same calendar year; and
(4) For any initial diagnosis made or treatment initiated for cancer or other neoplasms in the fourth quarter of a calendar year, on or before March 30 of the subsequent calendar year; and
(b) Health care facility and other facility that provides screening, diagnostic or therapeutic services to patients with respect to cancer and other neoplasms shall provide the information to the Chief Medical Officer required pursuant to subsection 1 within 6 months after a patient is admitted, initially diagnosed with or treated for cancer or another neoplasm.
3. Except as otherwise provided in subsection 4, each provider of health care described in subsection 1 and each health care facility and other facility that provides screening, diagnostic or therapeutic services to patients with respect to cancer and other neoplasms shall abstract information in conformance with the standards for abstracting information concerning neoplasms set forth in:
(a) Volumes I to V, inclusive, of the Standards for Cancer Registries, as adopted by reference in NAC 457.015; and
(b) The Facility Oncology Registry Data Standards (FORDS), as adopted by reference in NAC 457.015.
4. Ninety days after a publication specified in subsection 3 is revised, a provider of health care described in subsection 1 and a health care facility or other facility that provides screening, diagnostic or therapeutic services to patients with respect to cancer and other neoplasms shall abstract information in conformance with the revision unless the Chief Medical Officer files an objection to the revision pursuant to NAC 457.015.
5. A provider of health care described in subsection 1 and a health care facility or other facility that provides screening, diagnostic or therapeutic services to patients with respect to cancer and other neoplasms which does not use the staff of the Division to abstract information from its records shall cause to have abstracted and reported to the Division the neoplasms described in NAC 457.040 in the manner required by this section.
6. If a provider of health care or a health care facility or other facility that provides screening, diagnostic or therapeutic services to patients with respect to cancer and other neoplasms fails to comply with subsection 5, the Division shall give the provider of health care or the health care facility or other facility that provides screening, diagnostic or therapeutic services to patients with respect to cancer and other neoplasms at least 30 days after the time limit set forth in subsection 2 to comply with subsection 5 before the Division abstracts information from the records of the provider of health care or the health care facility or other facility that provides screening, diagnostic or therapeutic services to patients with respect to cancer and other neoplasms and the Chief Medical Officer charges the fee set forth in NAC 457.150.
7. The Chief Medical Officer may waive the requirement of submitting the information by electronic means pursuant to subsection 1 if the Chief Medical Officer determines that such a waiver is in the best interests of the general public.
8. If a provider of health care described in subsection 1 initially diagnoses a case of cancer or another neoplasm, the provider of health care is required to provide the information set forth in NAC 457.052 with regard to the initial diagnosis of cancer or other neoplasm. If the provider of health care does not provide treatment for the cancer or other neoplasm, the provider of health care’s responsibility to report information on that case of cancer or other neoplasm pursuant to this section and NRS 457.230 ends.
9. As used in this section, “initial diagnosis” or “initially diagnosed” means that the provider of health care or the health care facility or other facility that provides screening, diagnostic or therapeutic services to patients with respect to cancer and other neoplasms was the first provider of health care or the health care facility or other facility to designate a cancer code in the medical record of the patient and to inform the patient of his or her diagnosis. The term does not include the preparation of a diagnostic tool, including, without limitation, an image, if that diagnostic tool will be interpreted by another provider of health care or another health care facility or other facility that provides screening, diagnostic or therapeutic services to patients with respect to cancer and other neoplasms for the purpose of diagnosing cancer or another neoplasm.
(Added to NAC by Bd. of Health, eff. 12-3-84; A 10-22-93; R075-98, 11-18-98; R057-16, 5-16-2018)
NAC 457.052 Reporting of information by provider of health care, health care facility and certain other facilities: Required contents; request for variance from requirement. (NRS 457.065, 457.240)
1. A provider of health care who is required to report information on cases of cancer and other neoplasms pursuant to NRS 457.230 and each health care facility and other facility that provides screening, diagnostic or therapeutic services to patients with respect to cancer and other neoplasms must include, without limitation, the following information on the form provided to the Chief Medical Officer pursuant to NAC 457.050:
(a) The name, address, date of birth, gender and race or ethnicity of the patient, and, if available, the social security number of the patient and the name of the primary payer from which the provider of health care or the health care facility or other facility that provides screening, diagnostic or therapeutic services to patients with respect to cancer and neoplasms may receive payment for the services to the patient;
(b) Except as otherwise provided in subsection 2, the name, address and National Provider Identifier (NPI) number of the provider of health care or health care facility or other facility that provides screening, diagnostic or therapeutic services to patients with respect to cancer and neoplasms that is making the report;
(c) The date and final diagnosis of the patient;
(d) The anatomical site of the lesion; and
(e) The date of the last contact with the patient and the vital status of the patient at the time of the last contact.
2. If a company provides information for multiple health care facilities owned or operated by the company pursuant to subsection 4 of NAC 457.145, the only address that is required to be included is the address of the company providing the information.
3. A provider of health care and a health care facility and other facility that provides screening, diagnostic or therapeutic services to patients with respect to cancer and other neoplasms that is required pursuant to NAC 457.050 to provide the information set forth in subsection 1 and is unable to do so may request a variance from that requirement pursuant to NAC 439.200 to 439.280, inclusive, except that a variance is not necessary if the information required to be abstracted:
(a) Is not made available by the patient; or
(b) Is not readily obtainable, as determined by the Division, by the provider of health care or the health care facility or other facility that provides screening, diagnostic or therapeutic services to patients with respect to cancer and other neoplasms.
4. To the extent that information concerning which a variance could be requested is the subject of a notice of violation pursuant to NAC 457.145, a health care facility, or as applicable, a company that owns or operates multiple health care facilities, may defer making a request for a variance until the time allowed for correcting the violation expires, including any extension of time to correct the violation issued by the Division.
(Added to NAC by Bd. of Health by R057-16, eff. 5-16-2018)
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 or other neoplasms shall, within 10 working days after the date that the pathology report is completed, provide information concerning its findings to the Chief Medical Officer using an electronic means approved by the Chief Medical Officer or a designee thereof.
2. The information provided by a medical laboratory pursuant to subsection 1 must include, without limitation, for each specimen which shows evidence of cancer or other neoplasms which are subject to reporting pursuant to NAC 457.040:
(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 provider of health care 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; A by R057-16, 5-16-2018)
NAC 457.057 Reporting of information by provider of health care. (NRS 457.065, 457.240)
1. A provider of health care who has a case of cancer or another neoplasm in which the provider of health care has directly referred or previously admitted a patient to a hospital, medical laboratory or other facility that provides screening, diagnostic or therapeutic services to patients with respect to cancer and other neoplasms is not required to provide information concerning the case to the Chief Medical Officer pursuant to NAC 457.050, but may, within 30 working days after the date of the referral or admission, provide information to the Chief Medical Officer concerning the case on a form prescribed by the Chief Medical Officer or a designee thereof, or by an electronic means approved by the Chief Medical Officer or the designee.
2. Information provided by a provider of health care pursuant to subsection 1 may include, without limitation:
(a) The name, address, date of birth and gender of the patient;
(b) The name and the address or telephone number of the provider of health care making the report;
(c) The date and final diagnosis of the patient; and
(d) The name and the address or telephone number of the hospital, medical laboratory or other facility that provides screening, diagnostic or therapeutic services to patients with respect to cancer and other neoplasms to which the patient was referred or admitted.
3. The Chief Medical Officer or a designee thereof may contact a provider of health care regarding a patient of the provider of health care who was directly referred or previously admitted to a hospital, medical laboratory or other facility that provides screening, diagnostic or therapeutic services to patients with respect to cancer and other neoplasms if the Chief Medical Officer determines it is necessary for the abstraction of the required data relating to the incidence of cancer and other neoplasms.
(Added to NAC by Bd. of Health by R075-98, eff. 11-18-98; A by R057-16, 5-16-2018)
NAC 457.060 Confidentiality of information. (NRS 457.065, 457.240) All documents in the possession of the registry which contain names of patients, providers of health care, health care facilities or other facilities that provide screening, diagnostic or therapeutic services to patients with respect to cancer and other neoplasms or medical laboratories are confidential except the list of names of medical laboratories, health care facilities or other facilities that provide screening, diagnostic or therapeutic services to patients with respect to cancer and other neoplasms which report information to the registry.
(Added to NAC by Bd. of Health, eff. 12-3-84; A by R075-98, 11-18-98; R057-16, 5-16-2018)
NAC 457.070 Procedures for maintaining confidentiality of information. (NRS 457.065, 457.240) Each employee of the 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 Chief Medical 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 offices of Division. (NRS 457.065, 457.240) Each employee of the 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 provider of health care, health care facility or other facility that provides screening, diagnostic or therapeutic services to patients with respect to cancer and other neoplasms, the envelope or container must be addressed directly to the provider of health care or to the person designated by the health care facility or other facility that provides screening, diagnostic or therapeutic services to patients with respect to cancer and other neoplasms, to receive such information.
2. The Chief Medical Officer shall keep a list of the persons who have been designated by the chief administrator of the health care facility or other facility that provides screening, diagnostic or therapeutic services to patients with respect to cancer and other neoplasms to receive confidential information of the registry.
(Added to NAC by Bd. of Health, eff. 12-3-84; A 10-22-93; R057-16, 5-16-2018)
NAC 457.100 Persons with whom Chief Medical Officer contracts. (NRS 457.065, 457.240) If the Chief Medical 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 Chief Medical 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 Chief Medical 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 provider of health care who treated the patient;
(b) The health care facility, medical laboratory or other facility that provides screening, diagnostic or therapeutic services to patients with respect to cancer and other neoplasms where the patient was treated;
(c) A health care facility, medical laboratory or other facility that provides screening, diagnostic or therapeutic services to patients with respect to cancer and other neoplasms or a registry connected with one of those entities which has participated or is participating in treating the patient;
(d) Other states’ cancer registries or federal cancer control organizations with which the Department of Health and Human Services has entered into data sharing agreements which ensure confidentiality; or
(e) A qualified researcher in cancer.
2. If a request for information about a patient is made over the telephone by the provider of health care who treated the patient or by a representative of the health care facility, medical laboratory or other facility that provides screening, diagnostic or therapeutic services to patients with respect to cancer and other neoplasms 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; R057-16, 5-16-2018)
NAC 457.120 Disclosure of information: Requirements of person seeking information. (NRS 457.065, 457.240) The Chief Medical 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, medical laboratory or other facility that provides screening, diagnostic or therapeutic services to patients with respect to cancer and other neoplasms or registry connected with one of those entities 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; R057-16, 5-16-2018)
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 Chief Medical Officer. The applicant must:
(a) Set forth in the application:
(1) His or her qualifications as an epidemiologist, provider of health care 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 Chief Medical 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:
(1) Submit to the Chief Medical Officer or the designee for review and approval any proposed publication which is based on or contains information obtained from the registry;
(2) Notify the Chief Medical Officer if, at any time during the research project or before publishing any results, the applicant finds evidence of an increased risk or a decreased survival rate for cancer as compared to other states in either:
(I) A geographical area of this State; or
(II) A particular group of persons in this State, including, without limitation, a group of persons identifiable by age, gender, race, ethnicity, occupation, lifestyle or place of residence; and
(3) Include in any publication which is based on or contains information obtained from the registry the following disclosure in substantially the following form:
The views expressed herein are solely those of the author and do not necessarily reflect the views of the Division of Public and Behavioral Health of the Department of Health and Human Services.
2. The Chief Medical Officer or the designee must:
(a) Before a researcher is allowed access to information in the registry, make a written finding that the researcher is qualified as a researcher and has a need for the information; and
(b) Notify the Division as soon as practicable after the Chief Medical Officer receives notice of a finding described in subparagraph (2) of paragraph (c) of subsection 1. The Division shall independently assess the validity of the finding before the material may be published or released by the researcher.
(Added to NAC by Bd. of Health, eff. 12-3-84; A 1-24-92; R075-98, 11-18-98; R057-16, 5-16-2018)
NAC 457.145 Administrative penalty for violation; appeal; single report authorized for company that operates multiple facilities; imposition of administrative penalty upon company rather than facility. (NRS 457.065, 457.250)
1. Before imposing an administrative penalty pursuant to this section, the Division shall give notice in the manner set forth in NAC 439.345 which includes, without limitation, a time determined by the Chief Medical Officer within which the person must correct the violation of NRS 457.250. The Division may, for good cause shown, extend the time within which the person must correct the violation.
2. If a person fails to correct an alleged violation of NRS 457.250 for which a notice of violation has been issued pursuant to subsection 1 within the time allowed for correction, the Division may impose an administrative penalty of not more than $5,000 against the person.
3. If a person is aggrieved by a decision of the Division relating to the imposition of an administrative penalty pursuant to this section, the aggrieved person may appeal the decision pursuant to the procedures set forth in NAC 439.300 to 439.395, inclusive.
4. A company that owns and operates multiple health care facilities may satisfy the requirement set forth in subsection 1 of NRS 457.250 for all such health care facilities in one report without segregating by health care facility, or by provider of health care, the records subject to reporting.
5. If a company chooses to make the records subject to reporting available to the Chief Medical Officer or the Chief Medical Officer’s representative for multiple health care facilities owned or operated by the company in the manner described in subsection 4, any administrative penalty imposed by the Board pursuant to this section for the failure of any health care facility owned or operated by the company to comply with subsection 1 of NRS 457.250 will be imposed upon the company rather than the health care facility.
(Added to NAC by Bd. of Health by R057-16, eff. 5-16-2018)
NAC 457.150 Fees. (NRS 439.150, 457.065, 457.250, 457.260) The Chief Medical Officer shall charge and collect from:
1. A provider of health care who is required to report information on cases of cancer and other neoplasms pursuant to NRS 457.230 or a health care facility or other facility that provides screening, diagnostic or therapeutic services to patients with respect to cancer and other neoplasms, a fee of $250 for each abstract prepared by the Division from the records of the provider of health care or the health care facility or other facility.
2. A medical researcher who obtains data from the registry, a fee of $200 or the actual cost of providing the data, whichever is more.
(Added to NAC by Bd. of Health, eff. 12-3-84; A 8-31-89; 10-22-93; R075-98, 11-18-98; R057-16, 5-16-2018)
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 457.223 “Division” defined. (NRS 457.065) “Division” means the Division of Public and Behavioral Health 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) — (Substituted in revision for NAC 457.235)
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 457.240 “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 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 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 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 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 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; refund of portion of fees paid in error. (NRS 439.150, 457.065, 457.183, 457.184)
1. Except as otherwise provided in subsection 2, the Division shall charge and collect the following nonrefundable fees:
(a) For the issuance or renewal of a certificate for a machine, $551.
(b) For the issuance or renewal of a mammographer’s certificate, $88.
(c) For the issuance of a duplicate mammographer’s certificate for posting at multiple facilities for mammography pursuant to NAC 457.360, $25.
(d) For the issuance or renewal of a certificate to provide training to mammographers pursuant to NAC 457.357, $100.
2. If a payment was made in error, the Division will refund the fee collected pursuant to subsection 1, after deducting an amount calculated to cover the administrative costs directly related to issuing the refund.
(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; R144-13, 10-13-2016)
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 Division at least 30 days before the expiration of the certificate, the certificate will not expire until the 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 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 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 Division determines to be significant, the 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 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 Division during an investigation or inspection;
4. Fails or refuses to comply with a written request from the 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 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 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 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 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 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; statement regarding breast density and other information to be provided to patient. (NRS 457.065, 457.1857)
1. The operator of a facility shall ensure that:
(a) Each mammogram has a preliminary interpretation not later than 7 working days after the mammogram is performed;
(b) 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;
(c) 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
(d) Mammography records and reports comply with the provisions of 21 C.F.R. § 900.12.
2. If a patient undergoes mammography, the owner, lessee or other person responsible for the radiation machine used to perform the mammography shall ensure that each written report provided pursuant to 42 U.S.C. § 263b(f)(1)(G)(ii)(IV) includes a statement of the category of the patient’s breast density as required pursuant to NRS 457.1857 and a statement in substantially the following form:
Early detection of cancer is very important. Although mammography is one of the most accurate methods for early detection, not all cancers are found through mammography. Diagnosis by mammography may be limited by factors including, but not limited to, prior surgery, breast implants and breast density. Dense breast tissue is relatively common and is found in 40 percent of women. The presence of dense tissue makes it more difficult to detect cancer in the breast and may be associated with an increased risk of breast cancer. We are providing this information to raise your awareness of this important factor and to encourage you to discuss dense breast tissue and other breast cancer risk factors with your health care providers. Together, you can decide the appropriate schedule for your personal mammograms and whether any additional screenings should be considered because of your breast density or other breast cancer risk factors. Early detection of cancer is important and far outweighs any risk associated with a radiographic procedure. A report of your mammography results was sent to your physician.
(Added to NAC by Bd. of Health, eff. 7-7-94; A by R033-06, 6-28-2006; R100-13, 12-23-2013, eff. 1-1-2014)
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 Division to inspect the facility at any reasonable time.
2. Make available to an employee or other representative of the 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 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 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 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 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 Division. An applicant must:
(a) Satisfy the requirements of NRS 457.183; and
(b) Provide documentation satisfactory to the 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 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 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 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 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 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 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 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 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 Division or a national or regional organization approved by the 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 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 radiation 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; R144-13, 10-13-2016)
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)