(2) The color of material on which the label is printed must be white, the symbol red, and the printing in red or white as illustrated. (3) The label must be a rectangle measuring 51 millimeters (mm) (2 inches) high by 102.5 mm (4 inches) long. (4) The red symbol measuring 38 mm (11⁄2 inches) in diameter must be centered in a white square measuring 51 mm (2 inches) on each side. (5) Type size of the letters of label shall be as follows: Etiologic agents-10 pt. rev. In case of damage or leakage-10 pt. rev. Notify Director CDC, Atlanta, Georgia-8 pt.rev. 404-633-5313-10 pt. rev. (e) Damaged packages. The carrier shall promptly, upon discovery of evidence of leakage or any other damage to packages bearing an Etiologic Agents/Biomedical Material label, isolate the package and notify the Director, Center for Disease Control, 1600 Clifton Road, NE., Atlanta, GA 30333, by telephone: (404) 633-5313. The carrier shall also notify the sender. (f) Registered mail or equivalent system. Transportation of the following etiologic agents shall be by registered mail or an equivalent system which requires or provides for sending notification of receipt to the sender immediately upon delivery: Coccidioides immitis. Ebola virus. Francisella (Pasteurella) tularensis. Hemorrhagic fever agents including, but not limited to, Crimean hemorrhagic fever (Congo), Junin, Machupo viruses, and Korean hemorrhagic fever viruses. · Herpesvirus simiae (B virus). Histoplasma capsulatum. Lassa virus. Marburg virus. Pseudomonas mallei. Pseudomonas pseudomallei. Tick-borne encephalitis virus complex including, but not limited to, Russian spring-summer encephalitis, Kyasanur forest disease, Omsk Hemorrhagic fever, and Central European encephalitis viruses, Variola minor, and Variola major. Variola major, Variola minor, and Whitepox viruses. Yersinia (Pasteurella) pestis.3 § 72.4 Notice of delivery; failure to receive. When notice of delivery of materials known to contain or reasonably believed to contain etiologic agents listed in § 72.3(f) is not received by the This list may be revised from time to time by Notice published in the FEDERAL REGISTER to identify additional agents which must be transported in accordance with requirements contained in § 72.3(f). (a) As used in this part, all terms not defined herein shall have the meaning given them in the Act. (b) "Accredited institution" means an institution accredited by an agency or organization recognized for such purpose by the U.S. Commissioner of Education. (c) "Accredited laboratory" means a laboratory, or a laboratory in a hospital, accredited by an approved accreditation body. (d) "Act" means the Public Health Service Act, as amended, 42 U.S.C. 201, et seq. (e) "Approved accreditation body" means, with respect to hospitals, Joint Commission on the Accreditation of Hospitals, or American Osteopathic 90-149 0-82--7 Association, and with respect to laboratories, Commission on Inspection and Accreditation of the College of American Pathologists; or any other national accreditation body which has been approved by the Secretary as provided in section 353 of the Act. (f) "Director" means the Director of the National Communicable Disease Center, Health Services and Mental Health Administration, Department of Health and Human Services. (g) "Health insurance program" means the program created under Title XVIII of the Social Security Act, pursuant to which individuals are entitled to have payments made on their behalf for services performed by independent laboratories as provided in 20 CFR Part 405, 1 Subpart M. (h) A "physician" is a person licensed to practice medicine or osteopathy in any state or possession of the United States. (i) "Radiobioassay" includes (1) an examination to identify radionuclides or determine and quantitate body levels of radionuclides which are taken in by chronic or acute absorption, ingestion, or inhalation and (2) following the administration of a radioactive material to a patient, the subsequent analysis of a body fluid or excreta in order to evaluate body function. (j) A "referee laboratory" is a laboratory designated by the Secretary to examine specimens or other materials for purposes of proficiency testing using the same time schedule allowed for licensed laboratories and under conditions similar to those under which licensed laboratories examine materials. (k) A "reference laboratory" is a laboratory designated by the Secretary to authenticate the identification, content, and titer of samples and other materials used or to be used in proficiency testing. (1) "Secretary" means the Secretary of Health and Human Services or his designee. (m) "Specimen" means any material derived from the human body for examination or other procedure for the purpose of providing information for 'Redesignated as 42 CFR Part 405 at 42 FR 52826, Sept. 30, 1977. the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, man. [33 FR 20043, Dec. 31, 1968, as amended at 38 FR 10721, May 1, 1973] $74.2 Applicability. (a) Except as otherwise provided herein, the regulations in this part apply to laboratories engaged in the laboratory examination of, or other laboratory procedures relating to, specimens solicited or accepted in interstate commerce directly or indirectly, for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment, or the assessment of the health, of man. (b) The regulations in this part do not apply to the following:1 (1) Any laboratory with respect to any category in which it accepts no more than 100 specimens during any calendar year: Provided, That the laboratory holds an unrevoked and unsuspended letter of exemption for such category issued upon application submitted by such laboratory to the Director, National Communicable Disease Center, 1600 Clifton Road NE., Atlanta, Ga. 30333, and upon its agreement to maintain and make available such accession and other records, submit such information and reports, and comply with such provisions of this part as the Secretary may reasonably find necessary to determine its initial and continuing eligibility for exemption under this paragraph. For purposes of this paragraph, a category shall be one of the following: (i) Microbiology and serology; (ii) clinical chemistry; (iii) immunohematology; (iv) hematology; (v) pathology; (vi) radiobioassay. 'The coverage of services of independent laboratories under section 1861 of the Social Security Act, as amended, 42 U.S.C. 1395x, is subject to the provisions of Title 20, Code of Federal Regulations, Part 405,[redesignated as 42 CFR Part 405] and the regulation of biological products under section 351 of the Public Health Service Act, as amended, 42 U.S.C. 262, is subject to the provisions of Title 42, Code of Federal Regulations, Part 73. (2) Pursuant to section 353(i), any clinical laboratory operated by a licensed physician, osteopath, dentist, or podiatrist, or group thereof, who performs or perform laboratory tests or procedures solely as an adjunct to the treatment of his or their patients. (3) Pursuant to section 353(i), any laboratory with respect to tests or other procedures made by it for any person engaged in the business of insurance if made solely for the purposes of determining whether to write an insurance contract or of determining eligibility or continued eligibility for payments thereunder. (4) Clinical laboratories exempted by the Secretary pursuant to section 353(1) of the Act. (c) The requirements of this part for the issuance and renewal of licenses do not apply to an accredited laboratory: Provided, That the Secretary finds that the standards applied by the accrediting body are equal to or more stringent than the provisions of the Act and of this part and there is adequate provision for assuring that such standards continue to be met by such hospital and such laboratory: Provided further, That the laboratory holds an unrevoked and unsuspended letter of exemption issued pursuant to § 74.46. [33 FR 20043, Dec. 31, 1968, as amended at 35 FR 6177, Apr. 16, 1970] Subpart B-License: Applications and Issuance § 74.10 License application. (a) An application for the issuance or renewal of a license for a laboratory applicable to one or more laboratory procedures or categories of laboratory procedures for which standards are set out herein may be made to the Director by the owner, operator or authorized representative of such laboratory. (b) The application shall be made on form or forms prescribed by the Secretary, signed by the owner, operator, or by an authorized representative, and shall contain or be accompanied by such information, agreements and data as the Secretary may require, including an agreement that the applicant will operate the laboratory in accordance with standards which have been prescribed by the Secretary to carry out the purposes of the Act. (c) A separate application must be filed for each laboratory location. (d) [Reserved] (e) Licenses shall be issued to be applicable to one or more of the following procedures or categories of procedures except upon application for a limited license approved by the Secretary: (1) Microbiology and serology: (v) Serology (syphilis). (vi) Serology (nonsyphilis). (2) Clinical chemistry: (i) Blood and cerebrospinal fluid chemistry. (ii) Endocrinology. (3) Immuno-hematology. (i) Exfoliative cytology. (f) An application for the renewal of a license shall be submitted not less than 30 days nor more than 60 days prior to the expiration of the period for which the license was issued. [33 FR 20043, Dec. 31, 1968, as amended at 45 FR 26960, Apr. 22, 1980] § 74.11 Issuance or renewal of license. (a) If, after a review of the application and such additional information as the Secretary may require and an on site inspection of the laboratory premises with respect to which the license is sought, the Secretary is satisfied that such laboratory will be operated in accordance with the standards and other requirements of the Act and of this part and will provide consistent performance of accurate laboratory procedures and services, he shall issue an initial or renewal license with respect to such laboratory applicable to laboratory procedures or categories of procedures as specified therein. (b) Such initial or renewal license shall be issued for a term of 1 year. (c) If the Secretary determines that the application for the issuance or renewal of a license shall not be granted in whole or in part, he will, prior to denial of such application, give reasonable notice and opportunity for a hearing as provided herein to the applicant and a statement of the grounds on which it is proposed to deny the application or any part thereof. § 74.12 Reptitious applications. Where an application for a license has been denied in whole or in part, or a license has been revoked or limited, an application for a license to be applicable to procedures or categories of procedures affected by such adverse action made by or on behalf of the same applicant or licensee, shall not be accepted for consideration until after 1 year from the effective date of the adverse action: Provided, That upon good cause found, the Secretary may waive the application of this section. Subpart C-Quality Control § 74.20 General. Quality controls imposed and practiced by the laboratory must provide for and assure: (a) Preventive maintenance, periodic inspection and testing for proper operation of equipment and instruments, as may be appropriate; validation of methods; evaluation of reagents and volumetric equipment; surveillance of results; and remedial action to be taken in response to detected defects. (b) Adequacy of facilities, equipment, instruments, and methods for performance of the procedures or categories of procedures for which a license application is filed or granted; proper lighting for accuracy and precision; convenient location of essential utilities; monitoring of temperature controlled spaces and equipment, including water baths, incubators, sterilizers, and refrigerators, to assure proper performance; evaluation of analytical measuring devices, such as photometers and radioactivity counting equipment, with respect to all critical operating characteristics. (c) Labeling of all reagents and solutions to indicate identity, and when significant, titer, strength, or concentration, recommended storage requirements, preparation or expiration date, and other pertinent information. Materials of substandard reactivity and deteriorated materials may not be used. (d) The availability at all times, in the immediate bench area of personnel engaged in examining specimens and performing related procedures within a category (e.g., clinical chemistry, hematology, and pathology), of current laboratory manuals or other complete written descriptions and instructions relating to (1) the analytical methods used by those personnel, properly designated and dated to reflect the most recent supervisory reviews, (2) reagents, (3) control and calibration procedures, and (4) pertinent literature references. Text books may be used as supplements to such written descriptions but may not be used in lieu thereof. (e) Written approval by the director or supervisor of all changes in laboratory procedures. (f) Maintenance and availability to laboratory personnel and to the Secretary of records reflecting dates, and where appropriate the nature, of inspection, validation, remedial action, monitoring, evaluation, and changes and dates of changes in laboratory procedures. (g) Solicitation designed to provide for collection, preservation, and transportation of specimens sufficiently stable to provide accurate and precise results suitable for clinical interpretation. [33 FR 20043, Dec. 31, 1968, as amended at 38 FR 10721, May 1, 1973] 8 74.21 Microbiology. Chemical and biological solutions, reagents, and antisera shall be tested and inspected each day of use for reactivity and deterioration. (a) Bacteriology and mycology. Staining materials shall be tested for intended reactivity by concurrent application to smears of microorganisms with predictable staining characteristics. Each batch of medium shall be tested before or concurrently with use with selected organisms to confirm re |