Subpart H-Revocation, Suspension, and Limitation of Licenses and Letters of Exemption; Notice Sec. 74.60 Revocation, suspension, and limitation of licenses and letters of exemption. 74.61 Contents of notice. Subpart 1-Hearings [Reserved] AUTHORITY: Sec. 215, 58 Stat. 690; 42 U.S.C. 216. SOURCE: 33 FR 20043, Dec. 31, 1968, unless otherwise noted. Subpart A-Definitions and Applicability § 74.1 Definitions. (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 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, Education, and Welfare. (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 Title 20, Code of Federal Regulations, 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, Education, and Welfare 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 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 impair 'Redesignated as 42 CFR Part 405. (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. (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. '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. (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 874.10 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 a 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) The amount of the fee shall be $25 per annum for each of the categories enumerated in §74.2(b)(1). The applicant shall pay the appropriate fee upon notice by the Secretary prior to issuance of the license: Provided, That such fee of $25 per annum shall be imposed without regard to the number of procedures within each such category to which the license is applicable: Provided further, That the maximum fee required for each laboratory shall not exceed $125 per annum. (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). (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 38 FR 10721, May 1, 1973] § 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 reason able 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. Ma terials 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] § 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 required growth characteristics, selectivity, enrichment, and biochemical response. (b) Parasitology. A reference collection of slides, photographs, or gross specimens of identified parasites shall be available and used in the laboratory for appropriate comparison with diagnostic specimens. A calibrated ocular micrometer shall be used for determining the size of ova and parasites, if size is a critical factor. (c) Virology. Systems for the isolation of viruses and reagents for the identification of viruses shall be available to cover the entire range of viruses which are etiologically related to clinical diseases for which services are offered. Records shall be maintained which reflect the systems used and the reactions observed. In tests for the identification of viruses, controls shall be employed which will identify erroneous results. If serodiagnostic tests for virus diseases are performed, requirements for quality control as specified for serology shall apply. [33 FR 20043, Dec. 31, 1968, as amended at 38 FR 10722, May 1, 1973] § 74.22 Serology. (a) Serologic tests on unknown specimens shall be run concurrently with a positive control serum of known titer or controls of graded reactivity plus a negative control in order to detect variations in reactivity levels. Controls for all test components (antigens, complement, erythrocyte indicator systems, etc.), shall be employed to insure reactivity and uniform dosage. Test results shall not be reported unless the predetermined reactivity pattern of the controls is obtained. (b) Each new lot of reagent shall be tested concurrently with one of known acceptable reactivity before the new reagent is placed in routine use. (c) Equipment, glassware, reagents, controls, and techniques for tests for syphilis shall conform to those recommended in the "Manual of Tests for Syphilis 1969," USPHS Publication No. 411, January 1969.1 § 74.23 Clinical chemistry. (a) Each procedure shall be recalibrated or rechecked at least once on each day of use. Records shall be 'Obtainable from U.S. Government Printing Office. maintained and be available to laboratory personnel and the Secretary which document the routine precision of each method, automated or manual, and its recalibration schedule. At least one standard and one reference sample (control) shall be included with each run of unknown specimens where such standards and reference samples are available. Control limits for standards and reference samples shall be recorded and displayed and shall include the course of action to be instituted when the results are outside the acceptable limits. (b) Screening or qualitative chemical urinalysis shall be checked daily by use of suitable reference samples. § 74.24 Immuno-hematology. (a) ABO grouping shall be performed by testing unknown red cells with anti-A and anti-B grouping serums licensed under Part 73, Title 42, Code of Federal Regulations, or possessing equivalent potency, using the technique for which the serum is specifically designed to be effective. For confirmation of ABO grouping, the unknown serum shall be tested with known A1andB red cells. (b) The potency and reliability of reagents shall be checked each day of use. (c) The Rh.(D) type shall be determined by testing unknown red cells with anti-Rh.(anti-D) typing serum licensed under Part 73, Title 42, Code of Federal Regulations, or possessing equivalent potency, using the technique for which the serum is specifically designed to be effective. AntiRho'(CD), anti-Rh."(DE), and antiRhorh'rh"(CDE) serums licensed pursuant to Part 73, Title 42, Code of Federal Regulations, or possessing an equivalent potency may be used for typing donor blood. All Rh. negative donor and patient cells shall be tested for the Rh. variant (D2). A control system of patient's cells suspended in his own serum or in albumin shall be employed when the test is performed in a protein medium. (d) Rh.(D) positive and negative control tests shall be used for each test system employed to check the reactivity of the anti-Rh.(D) serum each day |