sor-one who meets the requirements of paragraph (b) of this section-is on the laboratory premises during all hours in which tests are being performed. A technical supervisor-one who meets the pertinent requirements of § 405.1314(b) spends an adequate amount of time in the laboratory to supervise the technical performance of the staff in his specialty and is readily available for personal or telephone consultation.

(2) A general supervisor may also be a technical supervisor.

(b) Standard. Supervisor-qualification. The laboratory supervisor meets the requirements of subparagraphs (1), (2), (3), (4), or (5), or (5) and (6) of this paragraph:

(1) He (i) is a physician or has earned a doctoral degree from an accredited institution with a chemical, physical, or biological science as his major subject, and (ii) subsequent to graduation has had at least 2 years' experience in one of the laboratory specialties in a clinical laboratory-with a director at the doctoral level-of a hospital, a health department, university, or medical research institution, or in a State which regulates clinical laboratory personnel, in a clinical laboratory acceptable to that State.

(2) He holds a degree of master of arts or master of science from an accredited institution with a major in one of the chemical, physical, or biological sciences and subsequent to graduation, has had at least 4 years of pertinent laboratory experience of which not less than 2 years has been spent working in the designated laboratory specialty in a a clinical laboratory-with a director at the doctoral level of a hospital, a health department, university, or medical research institution, or in a State which regulates clinical laboratory personnel, in a clinical laboratory acceptable to that State.

(3) He holds a degree of bachelor of arts or bachelor of science from an accredited institution with a major in one of the chemical, physical, or biological sciences, and, subsequent to graduation (1) has had at least 6 years of pertinent laboratory experience of which not less than 2 years has been spent working in the designated laboratory speciality in a clinical laboratory-with a director at the doctoral level-of a hospital, a health department, university, or medical research institution, or in a State which regulates clinical laboratory personnel,

in a clinical laboratory acceptable to that State; and (ii) has successfully completed pertinent courses which, when combined with the foregoing experience. will provide technical and professional knowledge comparable to that of subparagraph (2) of this paragraph.

(4) He is qualified as a clinical laboratory technologist pursuant to the provisions of 8 405.1315(b), (1), (2). (3), or (4), and (1) has had at least 6 years of pertinent laboratory experience of which not less than 2 years has been spent working in the designated laboratory specialty in a clinical laboratorywith a director at the doctoral level-of a hospital, university, health department, or medical research institution, or in a State which regulates clinical laboratory personnel, in a clinical laboratory acceptable to that State; and (ii) has successfully completed pertinent courses which, when combined with the foregoing experience, will provide a technical and professional knowledge comparable to that of subparagraph (2) of this paragraph.

(5) For a period ending June 30, 1971, an exception to the requirements in subparagraph (1), (2), (3), or (4) of this paragraph may be made if (i) the supervisor was performing the duties of a clinical laboratory supervisor on, or within the 5 years preceding July 1, 1966, and (11) the supervisor has had at least 15 years of pertinent clinical laboratory experience prior to July 1, 1966: Provided. That a minimum of 30 semester hours of credit toward a bachelor's degree with a chemical, physical, or a biological science as his major subject or 30 semester hours in an approved school of medical technology shall reduce the required years of experience by 2 years, with any addtional hours further reducing the required years of experience at the rate of 15 hours for 1 year.

(6) The supervisor who meets the requirements under subparagraph (5) of this paragraph may continue to qualify under the program after June 30, 1971, if he has performed the duties of a supervisor for at least 2 years between July 1, 1966, and July 1, 1971, or during the 15-year qualifying period in subparagraph (5) of this paragraph: (i) In a clinical laboratory—with a director at the doctoral level-of a hospital, university, health department, or medical research institution; or (ii) in a State which regulates clinical laboratory personnel, in a clinical laboratory acceptable

that State; or (iii) in a laboratory ›roved under the supplementary dical insurance program, Provided ɔ, That where qualifying years in a oratory described in (i) or (ii) of this agraph are obtained after June 30, 6, the laboratory meets applicable ditions under the health insurance gram.

F.R. 16137, Dec. 16, 1966, as amended at F.R. 490, Jan. 13, 1968; 33 F.R. 2384, 31, 1968]

05.1314

Condition-clinical laboratory; tests performed.

Subject to the provision that the rerements of this section shall be apcable only with respect to those tests 1 procedures performed for individuals olled under the supplementary mediinsurance plan (see Subpart B of this t 405), the clinical laboratory perms only those laboratory tests and cedures that are within the specialties which the laboratory director or suvisors are qualified.

a) Standard. Proficiency testing. To extent that a State health departnt, directly or through a local health artment, makes on-going proficiency ting services in one or more laboray specialties available to all or to a ss of laboratories, the laboratory parpates in the program in those specials in which the laboratory performs ts; and the laboratory does not perm tests in those specialties in which State or local health department rets an unfavorable evaluation. b) Standard. Procedures and testspetency. The laboratory performs y those laboratory procedures and s that are within the specialties or specialties in which the laboratory ector or supervisors are qualified. The tors explaining the standard are as

ows:

1) If the laboratory director or suvisor is a physician certified in both atomical and clinical pathology by American Board of Pathology or the erican Osteopathic Board of Patholor possesses qualifications which are ivalent to those required for certifica1 (board eligible), the laboratory y perform anatomical and clinical oratory procedures and tests in all cialties.

2) If the factor in subparagraph (1) his paragraph is not met and the labtory performs tests in the specialty microbiology, including the sub

specialties of bacteriology, serology, virology, mycology and parasitology, the director or a supervisor, as defined previously, (i) holds an earned doctoral or master's degree in microbiology from an accredited institution or is a physician and (ii) subsequent to graduation has had at least 4 years' experience in clinical microbiology.

(3) If the factor in subparagraph (1) of this paragraph is not met and the laboratory performs tests in the specialty of hematology, including gross and microscopic examination of the blood, the director or a supervisor as defined previously, holds a master's or bachelor's degree in biology, immunology, microbiology from an accredited institution and subsequent to graduation has had at least 4 years' experience in hematology.

or

(4) If the factor in subparagraph (1) of this paragraph is not met and (i) the laboratory performs tests in the specialty of immunohematology, the director or a supervisor, as defined previously, is a physician with at least 2 years' experience in clinical hematology subsequent to graduation, or (ii) within the specialty of immunohematology, the laboratory performs tests in the subspecialties of blood grouping and Rh typing only, the director or a supervisor, as defined previously, holds a master's or bachelor's degree in biology, immunology, or microbiology from an accredited institution and subsequent to graduation has had at least 4 years' experience in immunohematology.

(5) If the factor in subparagraph (1) of this paragraph is not met and the laboratory performs tests in the specialty of clinical chemistry, the director or a supervisor, as defined previously, (1) holds an earned doctoral or master's degree in chemistry or biochemistry from an accredited institution or is a physician, and (ii) subsequent to graduation has had at least 4 years' experience in clinical chemistry.

(6) If the factor in subparagraph (1) of this paragraph is not met and the laboratory performs tests in the specialty of tissue pathology, the director or a supervisor, as defined previously, is a physician who is certified in anatomical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possesses qualifications which are equivalent to those required for certification (board eligible).

(7) If the factor in subparagraph (1) of this paragraph is not met and the laboratory performs tests in the specialty of exfoliative cytology, the director or a supervisor, as defined previously, (i) is a physician who is certified by the American Board of Pathology, or the American Osteopathic Board of Pathology, or possesses qualifications which are equivalent to those required for certification or (ii) is a physician who is certified by the American Society of Cytology to practice cytopathology, or possesses qualifications which are equivalent to those required for certification, and the laboratory performs such tests only on that anatomic site for which he is certified, or (iii) is an individual who has demonstrated competency (a) through at least 7 years of accumulative experience in a position of diagnostic responsibility in the field of clinical cytology or through 5 years of full-time training in diagnostic clinical cytology with suitable endorsement by a physician who has been his supervisor in such activity; and (b) by the publishing of treatises, texts, and other publications on the subject of exfoliative cytology which are generally acknowledged and recognized by the medical profession as authoritative in the field; by his appointment to and service in pertinent teaching and research positions in recognized schools of medicine; by his acceptance into or award of membership and office in professional societies in this field; and by his receipt of other professional honors for excellence in the use of procedures in exfoliative cytology for the diagnosis of a pathological condition; and the laboratory performs such tests only on that anatomic site with respect to which such competency is so established. The Social Security Administra. tion, after documentation of the individual's qualifications by the State agency, will, with appropriate professional advice from the Public Health Service, make all determinations with respect to the requirements set forth in (iii) of this subparagraph. The individual who qualifies under (ii) or (iii) of this subparagraph is deemed also to meet the requirements of § 405.1312(b) (2) (ii) of this Subpart M.

(8) If the factor in subparagraph (1) or (6) of this paragraph is not met and the laboratory performs tests in oral pathology, the director or a supervisor is a dentist who is certified in oral pathology by the American Board of Oral Pathology or possesses qualifications

which are equivalent to those required for certification (board eligible).

(9) (i) The laboratory whose director qualifies under § 405.1312(b)(4), or § 405.1312(b) (4) and (5), may perform tests in the laboratory specialties in which such director is qualified by training and experience, or in which he has achieved a satisfactory grade through an examination conducted by or under the sponsorship of the U.S. Public Health Service, as discussed in § 405.1312(b) (4) (1) (c): Provided, That successful participation in a State-operated or Stateapproved proficiency testing program has been demonstrated in accordance with § 405.1312(b) (4). It performs tests in other laboratory specialties only if the supervisor meets the appropriate requirements of subparagraphs (1)-(8) of this paragraph; (ii) As used in this subparagraph, "training and experience" refers to the education and experience which qualified the individual as a director: (iii) the laboratory he directs may perform tests in:

(a) Microbiology, if he has a bachelor's degree in a biological science and subsequent to graduation has had at least 6 years of experience in microbiology; or, a master's degree and 4 such years.

(b) Hematology, if he meets the requirements of subparagraph (3) of this paragraph.

(c) Blood grouping and Rh typing, if he has a master's or bachelor's degree in biology, immunology, or microbiology and subsequent to graduation has had at least 4 years' experience in immunohematology.

(d) Clinical chemistry, if he has a bachelor's degree in chemistry, clinical chemistry, biochemistry, or pharmaceutical chemistry and 6 years of expenence in clinical chemistry; or, a master's degree and 4 such years.

(e) Any of the above specialties, if he has a bachelor's degree in medical technology and the designated experience in the specialty.

(10) The laboratory whose director qualifies under § 405.1312(b) (1), (2), or (3) may perform tests in the laboratory specialties with respect to which (i) such director or a supervisor meets the pertinent requirements of subparagraphs (1)–(8) and (9) (iii) of this paragraph or (ii) such director has achieved a satisfactory grade through an examination conducted by or under the sponsorship of the U.S. Public Health

Service. Such laboratories may be considered а class for purposes of §405.1314 (a).

(31 F.R. 16137, Dec. 16, 1966, as amended at 33 F.R. 491, Jan. 13, 1968]

§ 405.1315 Condition-clinical laboratory; technical personnel.

The clinical laboratory has a sufficient number of properly qualified technical personnel for the volume and diversity of tests performed.

(a) Standard. Technologist-duties. The laboratory employs a sufficient number of clinical laboratory technologists to proficiently perform under general supervision the clinical laboratory tests which require the exercise of independent judgment. The factors explaining the standard are as follows:

(1) The clinical laboratory technologists perform tests which require the exercise of independent judgment and responsibility, with minimal supervision by the director or supervisors, in only those specialties or subspecialties in which they are qualified by education, training, and experience.

(2) With respect to specialties in which the clinical laboratory technologist is not qualified by education, training, or experience, he functions only under direct supervision and performs only tests which require limited technical skill and responsibility.

(3) Clinical laboratory technologists are in sufficient number to adequately supervise the work of technicians and E trainees.

(b) Standard. Technologists—qualifications. Each clinical laboratory technologist possesses a current license as a clinical laboratory technologist issued by the State, if such licensing exists, and meets the requirements of subparagraphs (1), (2), (3), (4), or (5), or (5) and (6) of this paragraph:

(1) Successful completion of a full course of study which meets all academic requirements for a bachelor's degree in medical technology from an accredited college or university.

(2) Successful completion of 3 academic years of study (a minimum of 90 semester hours or equivalent) in an accredited college or university which met the specific requirements for entrance into, and the successful completion of a course of training of at least 12 months in, a school of medical technology approved by the Council on Medical Education and Hospitals of the American Medical Association.

(3) Successful completion in an accredited college or university of a course of study which meets all academic requirements for a bachelor's degree in one of the chemical, physical, or biological sciences, and, in addition, at least 1 year of pertinent laboratory experience and/ or training covering the specialty (ies) or subspecialty (ies) in which he performs tests, provided the combination has given the individual the equivalent in such specialty (ies) or subspecialty (ies) of the education and training described in subparagraph (1) or (2) of this paragraph.

(4) Successful completion of 3 years (90 semester hours or equivalent) in an accredited college or university with a distribution of courses as shown below, and, in addition, successful experience and/or training covering several fields of medical laboratory work of such length (not less than 1 year), and of such quality that this experience or training, when combined with the education, will have provided the individual with education and training in medical technology equivalent to that described in subparagraph (1) or (2) of this paragraph. Distribution of course work: (Where semester hours are stated, it is understood that the equivalent in quarter hours is equally acceptable. The specified courses must have included lecture and laboratory work. Survey courses are not acceptable.)

(i) For those whose training was completed prior to September 15, 1963: At least 24 semester hours in chemistry and biology courses of which not less than 9 semester hours must have been in chemistry and must have included at least 6 semester hours in inorganic chemistry, and not less than 12 semester hours must have been in biology courses pertinent to the medical sciences.

(ii) For those whose training was completed after September 15, 1963: Sixteen semester hours in chemistry courses which included at least 6 semester hours in inorganic chemistry and are acceptable toward a major in chemistry; 16 semester hours in biology courses which are pertinent to the medical sciences and are acceptable toward a major in the biological sciences; and 3 semester hours of mathematics.

(5) For a period ending June 30, 1971, an exception to the requirements in subparagraph (1), (2), (3), or (4) of this paragraph may be made if (i) the technologist was performing the duties of a

clinical laboratory technologist on, or within the 5 years preceding, July 1, 1966, and (ii) the technologist has had at least 10 years of pertinent clinical laboratory experience prior to July 1, 1966: Provided, That a minimum of 30 semester hours of credit toward a bachelor's degree from an accredited institution with a chemical, physical or a biological science as his major subject or 30 semester hours in an approved school of medical technology shall reduce the required years of experience by 2 years, with any additional hours further reducing the required years of experience at the rate of 15 hours for 1 year.

(6) The technologist who meets the requirements under subparagraph (5) of this paragraph may continue to qualify under the program after June 30, 1971, if he has performed the duties of a clinical laboratory technologist for at least 2 years between July 1, 1966, and July 1, 1971, or during the 10-year qualifying period in subparagraph (5): (i) In a clinical laboratory-with a director at the doctoral level-of a hospital, university, health department, or medical research institution; or (ii) in a State which regulates clinical laboratory personnel, in a clinical laboratory acceptable to that State; or (iii) in a laboratory approved under the supplementary medical insurance program: Provided also, That where qualifying years in a laboratory described in (i) or (ii) of this paragraph are obtained after June 30, 1966, the laboratory meets applicable conditions under the health insurance program.

(c) Standard. Technician-duties. Clinical laboratory technicians are employed in sufficient number to meet the workload demands of the laboratory and they function only under direct supervision of a clinical laboratory technologist. The factors explaining the standard are as follows:

(1) Each clinical laboratory technician performs only those laboratory procedures which require limited technical skill and responsibility and minimal exercise of independent judgment.

a

(2) No one with lesser qualifications than a clinical laboratory technician performs laboratory procedures, although manual and clerical supplemental services may be rendered by others.

(3) No clinical laboratory technician performs tests in the absence of a clinical laboratory technologist.

(d) Standard. Technician-qualifications. Each clinical laboratory technician possesses a current license as a clinical laboratory technician issued by the State, if such licensing exists, and meets the requirements of subparagraphs (1), (2), (3), or (4), or (4) and (5) of this paragraph:

(1) He is a high school graduate and subsequent to graduation has completed at least 1 year in a technician training program approved by the Council on Medical Education and Hospitals of the American Medical Association or approved by the Secretary.

(2) He is a high school graduate and subsequent to graduation has served 2 years as a technician trainee in a clinical laboratory with a director at the doctoral level, or in a State which regulates clinical laboratory personnel, in a clinical laboratory acceptable to that State.

(3) He is a high school graduate and subsequent to graduation has successfully completed an official military medical laboratory procedures course of at least 50 weeks duration, and has held, at the journeyman's level, the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician).

(4) For a period ending June 30, 1971, an exception to the requirements in subparagraph (1), (2), or (3) of this paragraph may be made if (i) the technician was performing the duties of a clinical laboratory technician on, or within the 5 years preceding, July 1, 1966, and (ii) the technician has had at least 5 years of pertinent clinical laboratory experience prior to July 1, 1966: Provided, That & minimum of 30 semester hours of credit toward a bachelor's degree from an accredited institution with a chemical, physical, or a biological science as his major subject or 30 semester hours in an approved school of medical technology shall reduce the required years of experience by 2 years, with any additional hours further reducing the required years of experience at the rate of 15 hours for 1 year: And provided also, That the required 5 years of experience shall not be so reduced by more than 4 years.

(5) The technician who meets the requirements under subparagraph (4) of this paragraph may continue to qualify under the program after June 30, 1971, if he has performed the duties of a clinical