Subpart M--Personnel for Moderate Complexity (Including the Subcategory)
and High Complexity Testing
Source: 57 FR 7172, Feb. 28, 1992, unless otherwise noted.
Sec. 493.1351 General.
This subpart consists of the personnel requirements that must be met
by laboratories performing moderate complexity testing, PPM procedures,
high complexity testing, or any combination of these tests.
[60 FR 20049, Apr. 24, 1995]
Laboratories Performing Provider-Performed Microscopy (PPM) Procedures
Source: 60 FR 20049, Apr. 24, 1995, unless otherwise noted.
Sec. 493.1353 Scope.
In accordance with Sec. 493.19(b), the moderate complexity
procedures specified as PPM procedures are considered such only when
personally performed by a health care provider during a patient visit in
the context of a physical examination. PPM procedures are subject to the
personnel requirements in Secs. 493.1355 through 493.1365.
Sec. 493.1355 Condition: Laboratories performing PPM procedures;
laboratory director.
The laboratory must have a director who meets the qualification
requirements of Sec. 493.1357 and provides overall management and
direction in accordance with Sec. 493.1359.
[[Page 960]]
Sec. 493.1357 Standard; laboratory director qualifications.
The laboratory director must be qualified to manage and direct the
laboratory personnel and the performance of PPM procedures as specified
in Sec. 493.19(c) and must be eligible to be an operator of a laboratory
within the requirements of subpart R of this part.
(a) The laboratory director must possess a current license as a
laboratory director issued by the State in which the laboratory is
located, if the licensing is required.
(b) The laboratory director must meet one of the following
requirements:
(1) Be a physician, as defined in Sec. 493.2.
(2) Be a midlevel practitioner, as defined in Sec. 493.2, authorized
by a State to practice independently in the State in which the
laboratory is located.
(3) Be a dentist, as defined in Sec. 493.2.
Sec. 493.1359 Standard; PPM laboratory director responsibilities.
The laboratory director is responsible for the overall operation and
administration of the laboratory, including the prompt, accurate, and
proficient reporting of test results. The laboratory director must--
(a) Direct no more than five laboratories; and
(b) Ensure that any procedure listed under Sec. 493.19(c)--
(1) Is personally performed by an individual who meets the
qualification requirements in Sec. 493.1363; and
(2) Is performed in accordance with applicable requirements in
subparts H, J, K, and M of this part.
Sec. 493.1361 Condition: Laboratories performing PPM procedures;
testing personnel.
The laboratory must have a sufficient number of individuals who meet
the qualification requirements of Sec. 493.1363 to perform the functions
specified in Sec. 493.1365 for the volume and complexity of testing
performed.
Sec. 493.1363 Standard: PPM testing personnel qualifications.
Each individual performing PPM procedures must--
(a) Possess a current license issued by the State in which the
laboratory is located if the licensing is required; and
(b) Meet one of the following requirements:
(1) Be a physician, as defined in Sec. 493.2.
(2) Be a midlevel practitioner, as defined in Sec. 493.2, under the
supervision of a physician or in independent practice if authorized by
the State in which the laboratory is located.
(3) Be a dentist as defined in Sec. 493.2 of this part.
Sec. 493.1365 Standard; PPM testing personnel responsibilities.
The testing personnel are responsible for specimen processing, test
performance, and for reporting test results. Any PPM procedure must be--
(a) Personally performed by one of the following practitioners:
(1) A physician during the patient's visit on a specimen obtained
from his or her own patient or from a patient of a group medical
practice of which the physician is a member or employee.
(2) A midlevel practitioner, under the supervision of a physician or
in independent practice if authorized by the State in which the
laboratory is located, during the patient's visit on a specimen obtained
from his or her own patient or from the patient of a clinic, group
medical practice, or other health care provider, in which the midlevel
practitioner is a member or an employee.
(3) A dentist during the patient's visit on a specimen obtained from
his or her own patient or from a patient of a group dental practice of
which the dentist is a member or an employee; and
(b) Performed using a microscope limited to a brightfield or a
phase/contrast microscope.
Laboratories Performing Moderate Complexity Testing
Sec. 493.1403 Condition: Laboratories performing moderate complexity
testing; laboratory director.
The laboratory must have a director who meets the qualification
requirements of Sec. 493.1405 of this subpart and
[[Page 961]]
provides overall management and direction in accordance with
Sec. 493.1407 of this subpart.
Sec. 493.1405 Standard; Laboratory director qualifications.
The laboratory director must be qualified to manage and direct the
laboratory personnel and the performance of moderate complexity tests
and must be eligible to be an operator of a laboratory within the
requirements of subpart R of this part.
(a) The laboratory director must possess a current license as a
laboratory director issued by the State in which the laboratory is
located, if such licensing is required; and
(b) The laboratory director must--
(1) (i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in anatomic or clinical pathology, or both, by the
American Board of Pathology or the American Osteopathic Board of
Pathology or possess qualifications that are equivalent to those
required for such certification; or
(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located; and
(ii) Have had laboratory training or experience consisting of:
(A) At least one year directing or supervising non-waived laboratory
testing; or
(B) Beginning September 1, 1993, have at least 20 continuing medical
education credit hours in laboratory practice commensurate with the
director responsibilities defined in Sec. 493.1407; or
(C) Laboratory training equivalent to paragraph (b)(2)(ii)(B) of
this section obtained during medical residency. (For example, physicians
certified either in hematology or hematology and medical oncology by the
American Board of Internal Medicine); or
(3) Hold an earned doctoral degree in a chemical, physical,
biological, or clinical laboratory science from an accredited
institution; and
(i) Be certified by the American Board of Medical Microbiology, the
American Board of Clinical Chemistry, the American Board of Bioanalysis,
or the American Board of Medical Laboratory Immunology; or
(ii) Have had at least one year experience directing or supervising
non-waived laboratory testing;
(4)(i) Have earned a master's degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution;
(ii) Have at least one year of laboratory training or experience, or
both in non-waived testing; and
(iii) In addition, have at least one year of supervisory laboratory
experience in non-waived testing; or
(5)(i) Have earned a bachelor's degree in a chemical, physical, or
biological science or medical technology from an accredited institution;
(ii) Have at least 2 years of laboratory training or experience, or
both in non-waived testing; and
(iii) In addition, have at least 2 years of supervisory laboratory
experience in non-waived testing;
(6) Be serving as a laboratory director and must have previously
qualified or could have qualified as a laboratory director under
Sec. 493.1406; or
(7) On or before February 28, 1992, qualified under State law to
direct a laboratory in the State in which the laboratory is located.
[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5233, Jan. 19, 1993]
Sec. 493.1406 Standard; Laboratory director qualifications on or before
February 28, 1992.
The laboratory director must be qualified to manage and direct the
laboratory personnel and test performance.
(a) The laboratory director must possess a current license as a
laboratory director issued by the State, if such licensing exists; and
(b) The laboratory director must:
(1) Be a physician certified in anatomical or clinical pathology (or
both) by the American Board of Pathology or the American Osteopathic
Board of Pathology or possess qualifications that are equivalent to
those required for such certification;
(2) Be a physician who:
[[Page 962]]
(i) Is certified by the American Board of Pathology or the American
Osteopathic Board of Pathology in at least one of the laboratory
specialties; or
(ii) Is certified by the American Board of Medical Microbiology, the
American Board of Clinical Chemistry, the American Board of Bioanalysis,
or other national accrediting board in one of the laboratory
specialties; or
(iii) Is certified by the American Society of Cytology to practice
cytopathology or possesses qualifications that are equivalent to those
required for such certification; or
(iv) Subsequent to graduation, has had 4 or more years of full-time
general laboratory training and experience of which at least 2 years
were spent acquiring proficiency in one of the laboratory specialties;
(3) For the subspecialty of oral pathology only, be certified by the
American Board of Oral Pathology, American Board of Pathology or the
American Osteopathic Board of Pathology or possesses qualifications that
are equivalent to those required for certification;
(4) Hold an earned doctoral degree from an accredited institution
with a chemical, physical, or biological science as a major subject and
(i) Is certified by the American Board of Medical Microbiology, the
American Board of Clinical Chemistry, the American Board of Bioanalysis,
or other national accrediting board acceptable to HHS in one of the
laboratory specialties; or
(ii) Subsequent to graduation, has had 4 or more years of full-time
general laboratory training and experience of which at least 2 years
were spent acquiring proficiency in one of the laboratory specialties;
(5) With respect to individuals first qualifying before July 1,
1971, have been responsible for the direction of a laboratory for 12
months between July 1, 1961, and January 1, 1968, and, in addition,
either:
(i) Was a physician and subsequent to graduation had at least 4
years of pertinent full-time laboratory experience;
(ii) Held a master's degree from an accredited institution with a
chemical, physical, or biological science as a major subject and
subsequent to graduation had at least 4 years of pertinent full-time
laboratory experience;
(iii) Held a bachelor's degree from an accredited institution with a
chemical, physical, or biological science as a major subject and
subsequent to graduation had at least 6 years of pertinent full-time
laboratory experience; or
(iv) Achieved a satisfactory grade through an examination conducted
by or under the sponsorship of the U.S. Public Health Service on or
before July 1, 1970; or
(6) Qualify under State law to direct the laboratory in the State in
which the laboratory is located.
Note: The January 1, 1968 date for meeting the 12 months' laboratory
direction requirement in paragraph (b)(5) of this section may be
extended 1 year for each year of full-time laboratory experience
obtained before January 1, 1958 required by State law for a laboratory
director license. An exception to the July 1, 1971 qualifying date in
paragraph (b)(5) of this section was made provided that the individual
requested qualification approval by October 21, 1975 and had been
employed in a laboratory for at least 3 years of the 5 years preceding
the date of submission of his qualifications.
[58 FR 5233, Jan. 19, 1993]
Sec. 493.1407 Standard; Laboratory director responsibilities.
The laboratory director is responsible for the overall operation and
administration of the laboratory, including the employment of personnel
who are competent to perform test procedures, and record and report test
results promptly, accurate, and proficiently and for assuring compliance
with the applicable regulations.
(a) The laboratory director, if qualified, may perform the duties of
the technical consultant, clinical consultant, and testing personnel, or
delegate these responsibilities to personnel meeting the qualifications
of Secs. 493.1409, 493.1415, and 493.1421, respectively.
(b) If the laboratory director reapportions performance of his or
her responsibilities, he or she remains responsible for ensuring that
all duties are properly performed.
(c) The laboratory director must be accessible to the laboratory to
provide onsite, telephone or electronic consultation as needed.
[[Page 963]]
(d) Each individual may direct no more than five laboratories.
(e) The laboratory director must--
(1) Ensure that testing systems developed and used for each of the
tests performed in the laboratory provide quality laboratory services
for all aspects of test performance, which includes the preanalytic,
analytic, and postanalytic phases of testing;
(2) Ensure that the physical plant and environmental conditions of
the laboratory are appropriate for the testing performed and provide a
safe environment in which employees are protected from physical,
chemical, and biological hazards;
(3) Ensure that--
(i) The test methodologies selected have the capability of providing
the quality of results required for patient care;
(ii) Verification procedures used are adequate to determine the
accuracy, precision, and other pertinent performance characteristics of
the method; and
(iii) Laboratory personnel are performing the test methods as
required for accurate and reliable results;
(4) Ensure that the laboratory is enrolled in an HHS approved
proficiency testing program for the testing performed and that--
(i) The proficiency testing samples are tested as required under
subpart H of this part;
(ii) The results are returned within the timeframes established by
the proficiency testing program;
(iii) All proficiency testing reports received are reviewed by the
appropriate staff to evaluate the laboratory's performance and to
identify any problems that require corrective action; and
(iv) An approved corrective action plan is followed when any
proficiency testing results are found to be unacceptable or
unsatisfactory;
(5) Ensure that the quality control and quality assessment programs
are established and maintained to assure the quality of laboratory
services provided and to identify failures in quality as they occur;
(6) Ensure the establishment and maintenance of acceptable levels of
analytical performance for each test system;
(7) Ensure that all necessary remedial actions are taken and
documented whenever significant deviations from the laboratory's
established performance specifications are identified, and that patient
test results are reported only when the system is functioning properly;
(8) Ensure that reports of test results include pertinent
information required for interpretation;
(9) Ensure that consultation is available to the laboratory's
clients on matters relating to the quality of the test results reported
and their interpretation concerning specific patient conditions;
(10) Employ a sufficient number of laboratory personnel with the
appropriate education and either experience or training to provide
appropriate consultation, properly supervise and accurately perform
tests and report test results in accordance with the personnel
responsibilities described in this subpart;
(11) Ensure that prior to testing patients' specimens, all personnel
have the appropriate education and experience, receive the appropriate
training for the type and complexity of the services offered, and have
demonstrated that they can perform all testing operations reliably to
provide and report accurate results;
(12) Ensure that policies and procedures are established for
monitoring individuals who conduct preanalytical, analytical, and
postanalytical phases of testing to assure that they are competent and
maintain their competency to process specimens, perform test procedures
and report test results promptly and proficiently, and whenever
necessary, identify needs for remedial training or continuing education
to improve skills;
(13) Ensure that an approved procedure manual is available to all
personnel responsible for any aspect of the testing process; and
(14) Specify, in writing, the responsibilities and duties of each
consultant and each person, engaged in the performance of the
preanalytic, analytic, and postanalytic phases of testing, that
identifies which examinations and procedures each individual is
authorized to perform, whether supervision is
[[Page 964]]
required for specimen processing, test performance or results reporting,
and whether consultant or director review is required prior to reporting
patient test results.
Sec. 493.1409 Condition: Laboratories performing moderate complexity
testing; technical consultant.
The laboratory must have a technical consultant who meets the
qualification requirements of Sec. 493.1411 of this subpart and provides
technical oversight in accordance with Sec. 493.1413 of this subpart.
Sec. 493.1411 Standard; Technical consultant qualifications.
The laboratory must employ one or more individuals who are qualified
by education and either training or experience to provide technical
consultation for each of the specialties and subspecialties of service
in which the laboratory performs moderate complexity tests or
procedures. The director of a laboratory performing moderate complexity
testing may function as the technical consultant provided he or she
meets the qualifications specified in this section.
(a) The technical consultant must possess a current license issued
by the State in which the laboratory is located, if such licensing is
required.
(b) The technical consultant must--
(1) (i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in anatomic or clinical pathology, or both, by the
American Board of Pathology or the American Osteopathic Board of
Pathology or possess qualifications that are equivalent to those
required for such certification; or
(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located; and
(ii) Have at least one year of laboratory training or experience, or
both in non-waived testing, in the designated specialty or subspecialty
areas of service for which the technical consultant is responsible (for
example, physicians certified either in hematology or hematology and
medical oncology by the American Board of Internal Medicine are
qualified to serve as the technical consultant in hematology); or
(3)(i) Hold an earned doctoral or master's degree in a chemical,
physical, biological or clinical laboratory science or medical
technology from an accredited institution; and
(ii) Have at least one year of laboratory training or experience, or
both in non-waived testing, in the designated specialty or subspecialty
areas of service for which the technical consultant is responsible; or
(4)(i) Have earned a bachelor's degree in a chemical, physical or
biological science or medical technology from an accredited institution;
and
(ii) Have at least 2 years of laboratory training or experience, or
both in non-waived testing, in the designated specialty or subspecialty
areas of service for which the technical consultant is responsible.
Note: The technical consultant requirements for ``laboratory
training or experience, or both'' in each specialty or subspecialty may
be acquired concurrently in more than one of the specialties or
subspecialties of service, excluding waived tests. For example, an
individual who has a bachelor's degree in biology and additionally has
documentation of 2 years of work experience performing tests of moderate
complexity in all specialties and subspecialties of service, would be
qualified as a technical consultant in a laboratory performing moderate
complexity testing in all specialties and subspecialties of service.
[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5234, Jan. 19, 1993]
Sec. 493.1413 Standard; Technical consultant responsibilities.
The technical consultant is responsible for the technical and
scientific oversight of the laboratory. The technical consultant is not
required to be onsite at all times testing is performed; however, he or
she must be available to the laboratory on an as needed basis to provide
consultation, as specified in paragraph (a) of this section.
(a) The technical consultant must be accessible to the laboratory to
provide on-site, telephone, or electronic consultation; and
[[Page 965]]
(b) The technical consultant is responsible for--
(1) Selection of test methodology appropriate for the clinical use
of the test results;
(2) Verification of the test procedures performed and the
establishment of the laboratory's test performance characteristics,
including the precision and accuracy of each test and test system;
(3) Enrollment and participation in an HHS approved proficiency
testing program commensurate with the services offered;
(4) Establishing a quality control program appropriate for the
testing performed and establishing the parameters for acceptable levels
of analytic performance and ensuring that these levels are maintained
throughout the entire testing process from the initial receipt of the
specimen, through sample analysis and reporting of test results;
(5) Resolving technical problems and ensuring that remedial actions
are taken whenever test systems deviate from the laboratory's
established performance specifications;
(6) Ensuring that patient test results are not reported until all
corrective actions have been taken and the test system is functioning
properly;
(7) Identifying training needs and assuring that each individual
performing tests receives regular in-service training and education
appropriate for the type and complexity of the laboratory services
performed;
(8) Evaluating the competency of all testing personnel and assuring
that the staff maintain their competency to perform test procedures and
report test results promptly, accurately and proficiently. The
procedures for evaluation of the competency of the staff must include,
but are not limited to--
(i) Direct observations of routine patient test performance,
including patient preparation, if applicable, specimen handling,
processing and testing;
(ii) Monitoring the recording and reporting of test results;
(iii) Review of intermediate test results or worksheets, quality
control records, proficiency testing results, and preventive maintenance
records;
(iv) Direct observation of performance of instrument maintenance and
function checks;
(v) Assessment of test performance through testing previously
analyzed specimens, internal blind testing samples or external
proficiency testing samples; and
(vi) Assessment of problem solving skills; and
(9) Evaluating and documenting the performance of individuals
responsible for moderate complexity testing at least semiannually during
the first year the individual tests patient specimens. Thereafter,
evaluations must be performed at least annually unless test methodology
or instrumentation changes, in which case, prior to reporting patient
test results, the individual's performance must be reevaluated to
include the use of the new test methodology or instrumentation.
Sec. 493.1415 Condition: Laboratories performing moderate complexity
testing; clinical consultant.
The laboratory must have a clinical consultant who meets the
qualification requirements of Sec. 493.1417 of this part and provides
clinical consultation in accordance with Sec. 493.1419 of this part.
Sec. 493.1417 Standard; Clinical consultant qualifications.
The clinical consultant must be qualified to consult with and render
opinions to the laboratory's clients concerning the diagnosis, treatment
and management of patient care. The clinical consultant must--
(a) Be qualified as a laboratory director under Sec. 493.1405(b)
(1), (2), or (3)(i); or
(b) Be a doctor of medicine, doctor of osteopathy or doctor of
podiatric medicine and possess a license to practice medicine,
osteopathy or podiatry in the State in which the laboratory is located.
[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5234, Jan. 19, 1993]
[[Page 966]]
Sec. 493.1419 Standard; Clinical consultant responsibilities.
The clinical consultant provides consultation regarding the
appropriateness of the testing ordered and interpretation of test
results. The clinical consultant must--
(a) Be available to provide clinical consultation to the
laboratory's clients;
(b) Be available to assist the laboratory's clients in ensuring that
appropriate tests are ordered to meet the clinical expectations;
(c) Ensure that reports of test results include pertinent
information required for specific patient interpretation; and
(d) Ensure that consultation is available and communicated to the
laboratory's clients on matters related to the quality of the test
results reported and their interpretation concerning specific patient
conditions.
Sec. 493.1421 Condition: Laboratories performing moderate complexity
testing; testing personnel.
The laboratory must have a sufficient number of individuals who meet
the qualification requirements of Sec. 493.1423, to perform the
functions specified in Sec. 493.1425 for the volume and complexity of
tests performed.
Sec. 493.1423 Standard; Testing personnel qualifications.
Each individual performing moderate complexity testing must--
(a) Possess a current license issued by the State in which the
laboratory is located, if such licensing is required; and
(b) Meet one of the following requirements:
(1) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located or have earned a doctoral, master's, or bachelor's degree in a
chemical, physical, biological or clinical laboratory science, or
medical technology from an accredited institution; or
(2) Have earned an associate degree in a chemical, physical or
biological science or medical laboratory technology from an accredited
institution; or
(3) Be a high school graduate or equivalent and have successfully
completed an official military medical laboratory procedures course of
at least 50 weeks duration and have held the military enlisted
occupational specialty of Medical Laboratory Specialist (Laboratory
Technician); or
(4)(i) Have earned a high school diploma or equivalent; and
(ii) Have documentation of training appropriate for the testing
performed prior to analyzing patient specimens. Such training must
ensure that the individual has--
(A) The skills required for proper specimen collection, including
patient preparation, if applicable, labeling, handling, preservation or
fixation, processing or preparation, transportation and storage of
specimens;
(B) The skills required for implementing all standard laboratory
procedures;
(C) The skills required for performing each test method and for
proper instrument use;
(D) The skills required for performing preventive maintenance,
troubleshooting and calibration procedures related to each test
performed;
(E) A working knowledge of reagent stability and storage;
(F) The skills required to implement the quality control policies
and procedures of the laboratory;
(G) An awareness of the factors that influence test results; and
(H) The skills required to assess and verify the validity of patient
test results through the evaluation of quality control sample values
prior to reporting patient test results.
[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5234, Jan. 19, 1993]
Sec. 493.1425 Standard; Testing personnel responsibilities.
The testing personnel are responsible for specimen processing, test
performance, and for reporting test results.
(a) Each individual performs only those moderate complexity tests
that are authorized by the laboratory director and require a degree of
skill commensurate with the individual's education, training or
experience, and technical abilities.
[[Page 967]]
(b) Each individual performing moderate complexity testing must--
(1) Follow the laboratory's procedures for specimen handling and
processing, test analyses, reporting and maintaining records of patient
test results;
(2) Maintain records that demonstrate that proficiency testing
samples are tested in the same manner as patient samples;
(3) Adhere to the laboratory's quality control policies, document
all quality control activities, instrument and procedural calibrations
and maintenance performed;
(4) Follow the laboratory's established corrective action policies
and procedures whenever test systems are not within the laboratory's
established acceptable levels of performance;
(5) Be capable of identifying problems that may adversely affect
test performance or reporting of test results and either must correct
the problems or immediately notify the technical consultant, clinical
consultant or director; and
(6) Document all corrective actions taken when test systems deviate
from the laboratory's established performance specifications.
Laboratories Performing High Complexity Testing
Sec. 493.1441 Condition: Laboratories performing high complexity
testing; laboratory director.
The laboratory must have a director who meets the qualification
requirements of Sec. 493.1443 of this subpart and provides overall
management and direction in accordance with Sec. 493.1445 of this
subpart.
Sec. 493.1443 Standard: Laboratory director qualifications.
The laboratory director must be qualified to manage and direct the
laboratory personnel and performance of high complexity tests and must
be eligible to be an operator of a laboratory within the requirements of
subpart R.
(a) The laboratory director must possess a current license as a
laboratory director issued by the State in which the laboratory is
located, if such licensing is required; and
(b) The laboratory director must--
(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in anatomic or clinical pathology, or both, by the
American Board of Pathology or the American Osteopathic Board of
Pathology or possess qualifications that are equivalent to those
required for such certification; or
(2) Be a doctor of medicine, a doctor of osteopathy or doctor of
podiatric medicine licensed to practice medicine, osteopathy or podiatry
in the State in which the laboratory is located; and
(i) Have at least one year of laboratory training during medical
residency (for example, physicians certified either in hematology or
hematology and medical oncology by the American Board of Internal
Medicine); or
(ii) Have at least 2 years of experience directing or supervising
high complexity testing; or
(3) Hold an earned doctoral degree in a chemical, physical,
biological or clinical laboratory science from an accredited institution
and--
(i) Be certified and continue to be certified by a board approved by HHS; or
(ii)Before February 24, 2003, must have served or be serving as a director
of a laboratory performing high complexity testing and must have at least--
(A) Two years of laboratory training or experience, or both; and
(B) Two years of laboratory experience directing or supervising high complexity testing.
(C) On December 31, 2002, individuals must meet the qualifications
specified in paragraph (b)(3)(i) of this section;
(4) Be serving as a laboratory director and must have previously
qualified or could have qualified as a laboratory director under
regulations at 42 CFR 493.1415, published March 14, 1990 at 55 FR 9538,
on or before February 28, 1992; or
(5) On or before February 28, 1992, be qualified under State law to
direct a laboratory in the State in which the laboratory is located; or
(6) For the subspecialty of oral pathology, be certified by the
American
[[Page 968]]
Board of Oral Pathology, American Board of Pathology, the American
Osteopathic Board of Pathology, or possess qualifications that are
equivalent to those required for certification.
[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5234, Jan. 19, 1993; 59
FR 62609, Dec. 6, 1994; 62 FR 25858, May 12, 1997; 63 FR 55034, Oct. 14,
1998]
Sec. 493.1445 Standard; Laboratory director responsibilities.
The laboratory director is responsible for the overall operation and
administration of the laboratory, including the employment of personnel
who are competent to perform test procedures, record and report test
results promptly, accurately and proficiently, and for assuring
compliance with the applicable regulations.
(a) The laboratory director, if qualified, may perform the duties of
the technical supervisor, clinical consultant, general supervisor, and
testing personnel, or delegate these responsibilities to personnel
meeting the qualifications under Secs. 493.1447, 493.1453, 493.1459, and
493.1487, respectively.
(b) If the laboratory director reapportions performance of his or
her responsibilities, he or she remains responsible for ensuring that
all duties are properly performed.
(c) The laboratory director must be accessible to the laboratory to
provide onsite, telephone or electronic consultation as needed.
(d) Each individual may direct no more than five laboratories.
(e) The laboratory director must--
(1) Ensure that testing systems developed and used for each of the
tests performed in the laboratory provide quality laboratory services
for all aspects of test performance, which includes the preanalytic,
analytic, and postanalytic phases of testing;
(2) Ensure that the physical plant and environmental conditions of
the laboratory are appropriate for the testing performed and provide a
safe environment in which employees are protected from physical,
chemical, and biological hazards;
(3) Ensure that--
(i) The test methodologies selected have the capability of providing
the quality of results required for patient care;
(ii) Verification procedures used are adequate to determine the
accuracy, precision, and other pertinent performance characteristics of
the method; and
(iii) Laboratory personnel are performing the test methods as
required for accurate and reliable results;
(4) Ensure that the laboratory is enrolled in an HHS-approved
proficiency testing program for the testing performed and that--
(i) The proficiency testing samples are tested as required under
subpart H of this part;
(ii) The results are returned within the timeframes established by
the proficiency testing program;
(iii) All proficiency testing reports received are reviewed by the
appropriate staff to evaluate the laboratory's performance and to
identify any problems that require corrective action; and
(iv) An approved corrective action plan is followed when any
proficiency testing result is found to be unacceptable or
unsatisfactory;
(5) Ensure that the quality control and quality assessment programs
are established and maintained to assure the quality of laboratory
services provided and to identify failures in quality as they occur;
(6) Ensure the establishment and maintenance of acceptable levels of
analytical performance for each test system;
(7) Ensure that all necessary remedial actions are taken and
documented whenever significant deviations from the laboratory's
established performance characteristics are identified, and that patient
test results are reported only when the system is functioning properly;
(8) Ensure that reports of test results include pertinent
information required for interpretation;
(9) Ensure that consultation is available to the laboratory's
clients on matters relating to the quality of the test results reported
and their interpretation concerning specific patient conditions;
(10) Ensure that a general supervisor provides on-site supervision
of high complexity test performance by testing
[[Page 969]]
personnel qualified under Sec. 493.1489(b)(4);
(11) Employ a sufficient number of laboratory personnel with the
appropriate education and either experience or training to provide
appropriate consultation, properly supervise and accurately perform
tests and report test results in accordance with the personnel
responsibilities described in this subpart;
(12) Ensure that prior to testing patients' specimens, all personnel
have the appropriate education and experience, receive the appropriate
training for the type and complexity of the services offered, and have
demonstrated that they can perform all testing operations reliably to
provide and report accurate results;
(13) Ensure that policies and procedures are established for
monitoring individuals who conduct preanalytical, analytical, and
postanalytical phases of testing to assure that they are competent and
maintain their competency to process specimens, perform test procedures
and report test results promptly and proficiently, and whenever
necessary, identify needs for remedial training or continuing education
to improve skills;
(14) Ensure that an approved procedure manual is available to all
personnel responsible for any aspect of the testing process; and
(15) Specify, in writing, the responsibilities and duties of each
consultant and each supervisor, as well as each person engaged in the
performance of the preanalytic, analytic, and postanalytic phases of
testing, that identifies which examinations and procedures each
individual is authorized to perform, whether supervision is required for
specimen processing, test performance or result reporting and whether
supervisory or director review is required prior to reporting patient
test results.
Sec. 493.1447 Condition: Laboratories performing high complexity
testing; technical supervisor.
The laboratory must have a technical supervisor who meets the
qualification requirements of Sec. 493.1449 of this subpart and provides
technical supervision in accordance with Sec. 493.1451 of this subpart.
Sec. 493.1449 Standard; Technical supervisor qualifications.
The laboratory must employ one or more individuals who are qualified
by education and either training or experience to provide technical
supervision for each of the specialties and subspecialties of service in
which the laboratory performs high complexity tests or procedures. The
director of a laboratory performing high complexity testing may function
as the technical supervisor provided he or she meets the qualifications
specified in this section.
(a) The technical supervisor must possess a current license issued
by the State in which the laboratory is located, if such licensing is
required; and
(b) The laboratory may perform anatomic and clinical laboratory
procedures and tests in all specialties and subspecialties of services
except histocompatibility and clinical cytogenetics services provided
the individual functioning as the technical supervisor--
(1) Is a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(2) Is certified in both anatomic and clinical pathology by the
American Board of Pathology or the American Osteopathic Board of
Pathology or Possesses qualifications that are equivalent to those
required for such certification.
(c) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the subspecialty of bacteriology,
the individual functioning as the technical supervisor must--
(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine,
[[Page 970]]
osteopathy, or podiatry in the State in which the laboratory is located;
and
(ii) Have at least one year of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of bacteriology; or
(3)(i) Have an earned doctoral degree in a chemical, physical,
biological or clinical laboratory science from an accredited
institution; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of bacteriology; or
(4)(i) Have earned a master's degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution; and
(ii) Have at least 2 years of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of bacteriology; or
(5)(i) Have earned a bachelor's degree in a chemical, physical, or
biological science or medical technology from an accredited institution;
and
(ii) Have at least 4 years of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of bacteriology.
(d) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the subspecialty of
mycobacteriology, the individual functioning as the technical supervisor
must--
(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor or
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of mycobacteriology; or
(3)(i) Have an earned doctoral degree in a chemical, physical,
biological or clinical laboratory science from an accredited
institution; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of mycobacteriology; or
(4)(i) Have earned a master's degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution; and
(ii) Have at least 2 years of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of mycobacteriology; or
(5)(i) Have earned a bachelor's degree in a chemical, physical or
biological science or medical technology from an accredited institution;
and
(ii) Have at least 4 years of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of mycobacteriology.
(e) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the subspecialty of mycology, the
individual functioning as the technical supervisor must--
(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in clinical pathology by the American Board of
Pathology or
[[Page 971]]
the American osteopathic Board of Pathology or possess qualifications
that are equivalent to those required for such certification; or
(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of mycology; or
(3)(i) Have an earned doctoral degree in a chemical, physical,
biological or clinical laboratory science from an accredited
institution; and
(ii) Have at least 1 year of laboratory training or experience, or
both in high complexity testing within the speciality of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of mycology; or
(4)(i) Have earned a master's degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution; and
(ii) Have at least 2 years of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of mycology; or
(5)(i) Have earned a bachelor's degree in a chemical, physical or
biological science or medical technology from an accredited institution;
and
(ii) Have at least 4 years of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of mycology.
(f) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the subspecialty of parasitology,
the individual functioning as the technical supervisor must--
(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located; and
(ii) Have at least one year of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of parasitology;
(3)(i) Have an earned doctoral degree in a chemical, physical,
biological or clinical laboratory science from an accredited
institution; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of parasitology; or
(4)(i) Have earned a master's degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution; and
(ii) Have at least 2 years of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of parasitology; or
(5)(i) Have earned a bachelor's degree in a chemical, physical or
biological science or medical technology from an accredited institution;
and
(ii) Have at least 4 years of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of parasitology.
(g) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the subspecialty of virology, the
individual
[[Page 972]]
functioning as the technical supervisor must--
(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of virology; or
(3)(i) Have an earned doctoral degree in a chemical, physical,
biological or clinical laboratory science from an accredited
institution; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of virology; or
(4)(i) Have earned a master's degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution; and
(ii) Have at least 2 years of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of virology; or
(5)(i) Have earned a bachelor's degree in a chemical, physical or
biological science or medical technology from an accredited institution;
and
(ii) Have at least 4 years of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of virology.
(h) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the specialty of diagnostic
immunology, the individual functioning as the technical supervisor
must--
(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing for the specialty of diagnostic
immunology; or
(3)(i) Have an earned doctoral degree in a chemical, physical,
biological or clinical laboratory science from an accredited
institution; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of diagnostic
immunology; or
(4)(i) Have earned a master's degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution; and
(ii) Have at least 2 years of laboratory training or experience, or
both, in high complexity testing for the specialty of diagnostic
immunology; or
(5) (i) Have earned a bachelor's degree in a chemical, physical or
biological science or medical technology from an accredited institution;
and
(ii) Have at least 4 years of laboratory training or experience, or
both, in high complexity testing for the specialty of diagnostic
immunology.
(i) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the specialty of chemistry, the
individual functioning as the technical supervisor must--
(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to
practice
[[Page 973]]
medicine or osteopathy in the State in which the laboratory is located;
and
(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing for the specialty of chemistry; or
(3)(i) Have an earned doctoral degree in a chemical, physical,
biological or clinical laboratory science from an accredited
institution; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of chemistry; or
(4)(i) Have earned a master's degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution; and
(ii) Have at least 2 years of laboratory training or experience, or
both, in high complexity testing for the specialty of chemistry; or
(5)(i) Have earned a bachelor's degree in a chemical, physical or
biological science or medical technology from an accredited institution;
and
(ii) Have at least 4 years of laboratory training or experience, or
both, in high complexity testing for the specialty of chemistry.
(j) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the specialty of hematology, the
individual functioning as the technical supervisor must--
(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located; and
(ii) Have at least one year of laboratory training or experience, or
both, in high complexity testing for the specialty of hematology (for
example, physicians certified either in hematology or hematology and
medical oncology by the American Board of Internal Medicine); or
(3)(i) Have an earned doctoral degree in a chemical, physical,
biological or clinical laboratory science from an accredited
institution; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of hematology; or
(4)(i) Have earned a master's degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution; and
(ii) Have at least 2 years of laboratory training or experience, or
both, in high complexity testing for the specialty of hematology; or
(5)(i) Have earned a bachelor's degree in a chemical, physical or
biological science or medical technology from an accredited institution;
and
(ii) Have at least 4 years of laboratory training or experience, or
both, in high complexity testing for the specialty of hematology.
(k)(1) If the requirements of paragraph (b) of this section are not
met and the laboratory performs tests in the subspecialty of cytology,
the individual functioning as the technical supervisor must--
(i) Be a doctor of medicine or a doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Meet one of the following requirements--
(A) Be certified in anatomic pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(B) Be certified by the American Society of Cytology to practice
cytopathology or possess qualifications
[[Page 974]]
that are equivalent to those required for such certification;
(2) An individual qualified under Sec. 493.1449(b) or paragraph
(k)(1) of this section may delegate some of the cytology technical
supervisor responsibilities to an individual who is in the final year of
full-time training leading to certification specified in paragraphs (b)
or (k)(1)(ii)(A) of this section provided the technical supervisor
qualified under Sec. 493.1449(b) or paragraph (k)(1) of this section
remains ultimately responsible for ensuring that all of the
responsibilities of the cytology technical supervisor are met.
(l) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the subspecialty of histopathology,
the individual functioning as the technical supervisor must--
(1) Meet one of the following requirements:
(i) (A) Be a doctor of medicine or a doctor of osteopathy licensed
to practice medicine or osteopathy in the State in which the laboratory
is located; and
(B) Be certified in anatomic pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification;
(ii) An individual qualified under Sec. 493.1449(b) or paragraph
(l)(1) of this section may delegate to an individual who is a resident
in a training program leading to certification specified in paragraph
(b) or (l)(1)(i)(B) of this section, the responsibility for examination
and interpretation of histopathology specimens.
(2) For tests in dermatopathology, meet one of the following
requirements:
(i) (A) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located and--
(B) Meet one of the following requirements:
(1) Be certified in anatomic pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2) Be certified in dermatopathology by the American Board of
Dermatology and the American Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(3) Be certified in dermatology by the American Board of Dermatology
or possess qualifications that are equivalent to those required for such
certification; or
(ii) An individual qualified under Sec. 493.1449(b) or paragraph
(l)(2)(i) of this section may delegate to an individual who is a
resident in a training program leading to certification specified in
paragraphs (b) or (l)(2)(i)(B) of this section, the responsibility for
examination and interpretation of dermatopathology specimens.
(3) For tests in ophthalmic pathology, meet one of the following
requirements:
(i)(A) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located and--
(B) Must meet one of the following requirements:
(1) Be certified in anatomic pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2) Be certified by the American Board of Ophthalmology or possess
qualifications that are equivalent to those required for such
certitication and have successfully completed at least 1 year of formal
post-residency fellowship training in ophthalmic pathology; or
(ii) An individual qualified under Sec. 493.1449(b) or paragraph
(1)(3)(i) of this section may delegate to an individual who is a
resident in a training program leading to certification specified in
paragraphs (b) or (1)(3)(i)(B) of this section, the responsibility for
examination and interpretation of ophthalmic specimens; or
(m) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the subspecialty of oral pathology,
the individual functioning as the technical supervisor must meet one of
the following requirements:
[[Page 975]]
(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located and--
(ii) Be certified in anatomic pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2) Be certified in oral pathology by the American Board of Oral
Pathology or possess qualifications for such certification; or
(3) An individual qualified under Sec. 493.1449(b) or paragraph (m)
(1) or (2) of this section may delegate to an individual who is a
resident in a training program leading to certification specified in
paragraphs (b) or (m) (1) or (2) of this section, the responsibility for
examination and interpretation of oral pathology specimens.
(n) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the specialty of radiobioassay, the
individual functioning as the technical supervisor must--
(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing for the specialty of radiobioassay; or
(3)(i) Have an earned doctoral degree in a chemical, physical,
biological or clinical laboratory science from an accredited
institution; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of radiobioassay;
or
(4)(i) Have earned a master's degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution; and
(ii) Have at least 2 years of laboratory training or experience, or
both, in high complexity testing for the specialty of radiobioassay; or
(5)(i) Have earned a bachelor's degree in a chemical, physical or
biological science or medical technology from an accredited institution;
and
(ii) Have at least 4 years of laboratory training or experience, or
both, in high complexity testing for the specialty of radiobioassay.
(o) If the laboratory performs tests in the specialty of
histocompatibility, the individual functioning as the technical
supervisor must either--
(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located; and
(ii) Have training or experience that meets one of the following
requirements:
(A) Have 4 years of laboratory training or experience, or both,
within the specialty of histocompatibility; or
(B)(1) Have 2 years of laboratory training or experience, or both,
in the specialty of general immunology; and
(2) Have 2 years of laboratory training or experience, or both, in
the specialty of histocompatibility; or
(2)(i) Have an earned doctoral degree in a biological or clinical
laboratory science from an accredited institution; and
(ii) Have training or experience that meets one of the following
requirements:
(A) Have 4 years of laboratory training or experience, or both,
within the specialty of histocompatibility; or
(B)(1) Have 2 years of laboratory training or experience, or both,
in the specialty of general immunology; and
(2) Have 2 years of laboratory training or experience, or both, in
the specialty of histocompatibility.
(p) If the laboratory performs tests in the specialty of clinical
cytogenetics, the individual functioning as the technical supervisor
must--
[[Page 976]]
(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located; and
(ii) Have 4 years of training or experience, or both, in genetics, 2
of which have been in clinical cytogenetics; or
(2)(i) Hold an earned doctoral degree in a biological science,
including biochemistry, or clinical laboratory science from an
accredited institution; and
(ii) Have 4 years of training or experience, or both, in genetics, 2
of which have been in clinical cytogenetics.
(q) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the specialty of immunohematology,
the individual functioning as the technical supervisor must--
(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located; and
(ii) Have at least one year of laboratory training or experience, or
both, in high complexity testing for the specialty of immunohematology.
Note: The technical supervisor requirements for ``laboratory
training or experience, or both'' in each specialty or subspecialty may
be acquired concurrently in more than one of the specialties or
subspecialties of service. For example, an individual, who has a
doctoral degree in chemistry and additionally has documentation of 1
year of laboratory experience working concurrently in high complexity
testing in the specialties of microbiology and chemistry and 6 months of
that work experience included high complexity testing in bacteriology,
mycology, and mycobacteriology, would qualify as the technical
supervisor for the specialty of chemistry and the subspecialties of
bacteriology, mycology, and mycobacteriology.
[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5234, Jan. 19, 1993]
Sec. 493.1451 Standard: Technical supervisor responsibilities.
The technical supervisor is responsible for the technical and
scientific oversight of the laboratory. The technical supervisor is not
required to be on site at all times testing is performed; however, he or
she must be available to the laboratory on an as needed basis to provide
supervision as specified in (a) of this section.
(a) The technical supervisor must be accessible to the laboratory to
provide on-site, telephone, or electronic consultation; and
(b) The technical supervisor is responsible for--
(1) Selection of the test methodology that is appropriate for the
clinical use of the test results;
(2) Verification of the test procedures performed and establishment
of the laboratory's test performance characteristics, including the
precision and accuracy of each test and test system;
(3) Enrollment and participation in an HHS approved proficiency
testing program commensurate with the services offered;
(4) Establishing a quality control program appropriate for the
testing performed and establishing the parameters for acceptable levels
of analytic performance and ensuring that these levels are maintained
throughout the entire testing process from the initial receipt of the
specimen, through sample analysis and reporting of test results;
(5) Resolving technical problems and ensuring that remedial actions
are taken whenever test systems deviate from the laboratory's
established performance specifications;
(6) Ensuring that patient test results are not reported until all
corrective actions have been taken and the test system is functioning
properly;
(7) Identifying training needs and assuring that each individual
performing tests receives regular in-service training and education
appropriate for the type and complexity of the laboratory services
performed;
[[Page 977]]
(8) Evaluating the competency of all testing personnel and assuring
that the staff maintain their competency to perform test procedures and
report test results promptly, accurately and proficiently. The
procedures for evaluation of the competency of the staff must include,
but are not limited to--
(i) Direct observations of routine patient test performance,
including patient preparation, if applicable, specimen handling,
processing and testing;
(ii) Monitoring the recording and reporting of test results;
(iii) Review of intermediate test results or worksheets, quality
control records, proficiency testing results, and preventive maintenance
records;
(iv) Direct observation of performance of instrument maintenance and
function checks;
(v) Assessment of test performance through testing previously
analyzed specimens, internal blind testing samples or external
proficiency testing samples; and
(vi) Assessment of problem solving skills; and
(9) Evaluating and documenting the performance of individuals
responsible for high complexity testing at least semiannually during the
first year the individual tests patient specimens. Thereafter,
evaluations must be performed at least annually unless test methodology
or instrumentation changes, in which case, prior to reporting patient
test results, the individual's performance must be reevaluated to
include the use of the new test methodology or instrumentation.
(c) In cytology, the technical supervisor or the individual
qualified under Sec. 493.1449(k)(2)--
(1) May perform the duties of the cytology general supervisor and
the cytotechnologist, as specified in Secs. 493.1471 and 493.1485,
respectively;
(2) Must establish the workload limit for each individual examining
slides;
(3) Must reassess the workload limit for each individual examining
slides at least every 6 months and adjust as necessary;
(4) Must perform the functions specified in Sec. Sec. 493.1274(d) and (e);
(5) Must ensure that each individual examining gynecologic
preparations participates in an HHS approved cytology proficiency
testing program, as specified in Sec. 493.945 and achieves a passing
score, as specified in Sec. 493.855; and
(6) If responsible for screening cytology slide preparations, must
document the number of cytology slides screened in 24 hours and the
number of hours devoted during each 24-hour period to screening cytology
slides.
[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5235, Jan. 19, 1993]
Sec. 493.1453 Condition: Laboratories performing high complexity
testing; clinical consultant.
The laboratory must have a clinical consultant who meets the
requirements of Sec. 493.1455 of this subpart and provides clinical
consultation in accordance with Sec. 493.1457 of this subpart.
Sec. 493.1455 Standard; Clinical consultant qualifications.
The clinical consultant must be qualified to consult with and render
opinions to the laboratory's clients concerning the diagnosis, treatment
and management of patient care. The clinical consultant must--
(a) Be qualified as a laboratory director under Sec. 493.1443(b)(1),
(2), or (3)(i) or, for the subspecialty of oral pathology,
Sec. 493.1443(b)(6); or
(b) Be a doctor of medicine, doctor of osteopathy, doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located.
[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5235, Jan. 19, 1993]
Sec. 493.1457 Standard; Clinical consultant responsibilities.
The clinical consultant provides consultation regarding the
appropriateness of the testing ordered and interpretation of test
results. The clinical consultant must--
(a) Be available to provide consultation to the laboratory's
clients;
(b) Be available to assist the laboratory's clients in ensuring that
appropriate tests are ordered to meet the clinical expectations;
(c) Ensure that reports of test results include pertinent
information required for specific patient interpretation; and
[[Page 978]]
(d) Ensure that consultation is available and communicated to the
laboratory's clients on matters related to the quality of the test
results reported and their interpretation concerning specific patient
conditions.
Sec. 493.1459 Condition: Laboratories performing high complexity
testing; general supervisor.
The laboratory must have one or more general supervisors who are
qualified under Sec. 493.1461 of this subpart to provide general
supervision in accordance with Sec. 493.1463 of this subpart.
Sec. 493.1461 Standard: General supervisor qualifications.
The laboratory must have one or more general supervisors who, under
the direction of the laboratory director and supervision of the
technical supervisor, provides day-to-day supervision of testing
personnel and reporting of test results. In the absence of the director
and technical supervisor, the general supervisor must be responsible for
the proper performance of all laboratory procedures and reporting of
test results.
(a) The general supervisor must possess a current license issued by
the State in which the laboratory is located, if such licensing is
required; and
(b) The general supervisor must be qualified as a--
(1) Laboratory director under Sec. 493.1443; or
(2) Technical supervisor under Sec. 493.1449.
(c) If the requirements of paragraph (b)(1) or paragraph (b)(2) of
this section are not met, the individual functioning as the general
supervisor must--
(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located or have earned
a doctoral, master's, or bachelor's degree in a chemical, physical,
biological or clinical laboratory science, or medical technology from an
accredited institution; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing; or
(2)(i) Qualify as testing personnel under Sec. 493.1489(b)(2); and
(ii) Have at least 2 years of laboratory training or experience, or
both, in high complexity testing; or
(3)(i) Except as specified in paragraph (3)(ii) of this section,
have previously qualified as a general supervisor under Sec. 493.1462 on
or before February 28, 1992.
(ii) Exception. An individual who achieved a satisfactory grade in a
proficiency examination for technologist given by HHS between March 1,
1986 and December 31, 1987, qualifies as a general supervisor if he or
she meets the requirements of Sec. 493.1462 on or before January 1,
1994.''
(4) On or before September 1, 1992, have served as a general
supervisor of high complexity testing and as of April 24, 1995--
(i) Meet one of the following requirements:
(A) Have graduated from a medical laboratory or clinical laboratory
training program approved or accredited by the Accrediting Bureau of
Health Education Schools (ABHES), the Commission on Allied Health
Education Accreditation (CAHEA), or other organization approved by HHS.
(B) Be a high school graduate or equivalent and have successfully
completed an official U.S. military medical laboratory procedures course
of at least 50 weeks duration and have held the military enlisted
occupational specialty of Medical Laboratory Specialist (Laboratory
Technician).
(ii) Have at least 2 years of clinical laboratory training, or
experience, or both, in high complexity testing; or
(5) On or before September 1, 1992, have served as a general
supervisor of high complexity testing and--
(i) Be a high school graduate or equivalent; and
(ii) Have had at least 10 years of laboratory training or
experience, or both, in high complexity testing, including at least 6
years of supervisory experience between September 1, 1982 and September
1, 1992.
(d) For blood gas analysis, the individual providing general
supervision must--
(1) Be qualified under Secs. 493.1461(b) (1) or (2), or 493.1461(c);
or
[[Page 979]]
(2)(i) Have earned a bachelor's degree in respiratory therapy or
cardiovascular technology from an accredited institution; and
(ii) Have at least one year of laboratory training or experience, or
both, in blood gas analysis; or
(3)(i) Have earned an associate degree related to pulmonary function
from an accredited institution; and
(ii) Have at least two years of training or experience, or both in
blood gas analysis.
(e) The general supervisor requirement is met in histopathology,
oral pathology, dermatopathology, and ophthalmic pathology because all
tests and examinations, must be performed:
(1) In histopathology, by an individual who is qualified as a
technical supervisor under Secs. 493.1449(b) or 493.1449(l)(1);
(2) In dermatopathology, by an individual who is qualified as a
technical supervisor under Secs. 493.1449(b) or 493.1449(l) or (2);
(3) In ophthalmic pathology, by an individual who is qualified as a
technical supervisor under Secs. 493.1449(b) or 493.1449(1)(3); and
(4) In oral pathology, by an individual who is qualified as a
technical supervisor under Secs. 493.1449(b) or 493.1449(m).
[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5235, Jan. 19, 1993; 58
FR 39155, July 22, 1993; 60 FR 20049, Apr. 24, 1995]
Sec. 493.1462 General supervisor qualifications on or before February
28, 1992.
To qualify as a general supervisor under Sec. 493.1461(c)(3), an
individual must have met or could have met the following qualifications
as they were in effect on or before February 28, 1992.
(a) Each supervisor possesses a current license as a laboratory
supervisor issued by the State, if such licensing exists; and
(b) The laboratory supervisor--
(1) Who qualifies as a laboratory director under
Sec. 493.1406(b)(1), (2), (4), or (5) is also qualified as a general
supervisor; therefore, depending upon the size and functions of the
laboratory, the laboratory director may also serve as the laboratory
supervisor; or
(2)(i) Is a physician or has earned a doctoral degree from an
accredited institution with a major in one of the chemical, physical, or
biological sciences; and
(ii) Subsequent to graduation, has had at least 2 years of
experience in one of the laboratory specialties in a laboratory; or
(3)(i) Holds a master's degree from an accredited institution with a
major in one of the chemical, physical, or biological sciences; and
(ii) Subsequent to graduation has had at least 4 years of pertinent
full-time laboratory experience of which not less than 2 years have been
spent working in the designated specialty in a laboratory; or
(4)(i) Is qualified as a laboratory technologist under
Sec. 493.1491; and
(ii) After qualifying as a laboratory technologist, has had at least
6 years of pertinent full-time laboratory experience of which not less
than 2 years have been spent working in the designated laboratory
specialty in a laboratory; or
(5) With respect to individuals first qualifying before July 1,
1971, has had at least 15 years of pertinent full-time laboratory
experience before January 1, 1968; this required experience may be met
by the substitution of education for experience.
[58 FR 39155, July 22, 1993]
Sec. 493.1463 Standard: General supervisor responsibilities.
The general supervisor is responsible for day-to-day supervision or
oversight of the laboratory operation and personnel performing testing
and reporting test results.
(a) The general supervisor--(1) Must be accessible to testing
personnel at all times testing is performed to provide on-site,
telephone or electronic consultation to resolve technical problems in
accordance with policies and procedures established either by the
laboratory director or technical supervisor;
(2) Is responsible for providing day-to-day supervision of high
complexity test performance by a testing personnel qualified under
Sec. 493.1489;
(3) Except as specified in paragraph (c) of this section, must be
onsite to provide direct supervision when high
[[Page 980]]
complexity testing is performed by any individuals qualified under
Sec. 493.1489(b)(5); and
(4) Is responsible for monitoring test analyses and specimen
examinations to ensure that acceptable levels of analytic performance
are maintained.
(b) The director or technical supervisor may delegate to the general
supervisor the responsibility for--
(1) Assuring that all remedial actions are taken whenever test
systems deviate from the laboratory's established performance
specifications;
(2) Ensuring that patient test results are not reported until all
corrective actions have been taken and the test system is properly
functioning;
(3) Providing orientation to all testing personnel; and
(4) Annually evaluating and documenting the performance of all
testing personnel.
(c) Exception. For individuals qualified under Sec. 493.1489(b)(5),
who were performing high complexity testing on or before January 19,
1993, the requirements of paragraph (a)(3) of this section are not
effective, provided that all high complexity testing performed by the
individual in the absence of a general supervisor is reviewed within 24
hours by a general supervisor qualified under Sec. 493.1461.
[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5235, Jan. 19, 1993; 60
FR 20050, Apr. 24, 1995]
Sec. 493.1467 Condition: Laboratories performing high complexity
testing; cytology general supervisor.
For the subspecialty of cytology, the laboratory must have a general
supervisor who meets the qualification requirements of Sec. 493.1469 of
this subpart, and provides supervision in accordance with Sec. 493.1471
of this subpart.
Sec. 493.1469 Standard: Cytology general supervisor qualifications.
The cytology general supervisor must be qualified to supervise
cytology services. The general supervisor in cytology must possess a
current license issued by the State in which the laboratory is located,
if such licensing is required, and must--
(a) Be qualified as a technical supervisor under Sec. 493.1449 (b)
or (k); or
(b)(1) Be qualified as a cytotechnologist under Sec. 493.1483; and
(2) Have at least 3 years of full-time (2,080 hours per year)
experience as a cytotechnologist within the preceding 10 years.
Sec. 493.1471 Standard: Cytology general supervisor responsibilities.
The technical supervisor of cytology may perform the duties of the
cytology general supervisor or delegate the responsibilities to an
individual qualified under Sec. 493.1469.
(a) The cytology general supervisor is responsible for the day-to-
day supervision or oversight of the laboratory operation and personnel
performing testing and reporting test results.
(b) The cytology general supervisor must--
(1) Be accessible to provide on-site, telephone, or electronic
consultation to resolve technical problems in accordance with policies
and procedures established by the technical supervisor of cytology;
(2) Document the slide interpretation results of each gynecologic
and nongynecologic cytology case he or she examined or reviewed (as
specified under Sec.493.1274(c));
(3) For each 24-hour period, document the total number of slides he
or she examined or reviewed in the laboratory as well as the total
number of slides examined or reviewed in any other laboratory or for any
other employer; and
(4) Document the number of hours spent examining slides in each 24-
hour period.
Sec. 493.1481 Condition: Laboratories performing high complexity
testing; cytotechnologist.
For the subspecialty of cytology, the laboratory must have a
sufficient number of cytotechnologists who meet the qualifications
specified in Sec. 493.1483 to perform the functions specified in
Sec. 493.1485.
Sec. 493.1483 Standard: Cytotechnologist qualifications.
Each person examining cytology slide preparations must meet the
qualifications of Sec. 493.1449 (b) or (k), or--
(a) Possess a current license as a cytotechnologist issued by the
State in
[[Page 981]]
which the laboratory is located, if such licensing is required; and
(b) Meet one of the following requirements:
(1) Have graduated from a school of cytotechnology accredited by the
Committee on Allied Health Education and Accreditation or other
organization approved by HHS; or
(2) Be certified in cytotechnology by a certifying agency approved
by HHS; or
(3) Before September 1, 1992--
(i) Have successfully completed 2 years in an accredited institution
with at least 12 semester hours in science, 8 hours of which are in
biology; and
(A) Have had 12 months of training in a school of cytotechnology
accredited by an accrediting agency approved by HHS; or
(B) Have received 6 months of formal training in a school of
cytotechnology accredited by an accrediting agency approved by HHS and 6
months of full-time experience in cytotechnology in a laboratory
acceptable to the pathologist who directed the formal 6 months of
training; or
(ii) Have achieved a satisfactory grade to qualify as a
cytotechnologist in a proficiency examination approved by HHS and
designed to qualify persons as cytotechnologists; or
(4) Before September 1, 1994, have full-time experience of at least
2 years or equivalent within the preceding 5 years examining slide
preparations under the supervision of a physician qualified under
Sec. 493.1449(b) or (k)(1), and before January 1, 1969, must have--
(i) Graduated from high school;
(ii) Completed 6 months of training in cytotechnology in a
laboratory directed by a pathologist or other physician providing
cytology services; and
(iii) Completed 2 years of full-time supervised experience in
cytotechnology; or
(5)(i) On or before September 1, 1994, have full-time experience of
at least 2 years or equivalent examining cytology slide preparations
within the preceding 5 years in the United States under the supervision
of a physician qualified under Sec. 493.1449(b) or (k)(1); and
(ii) On or before September 1, 1995, have met the requirements in
either paragraph (b)(1) or (2) of this section.
[57 FR 7172, Feb. 28, 1992, as amended at 59 FR 685, Jan. 6, 1994]
Sec. 493.1485 Standard; Cytotechnologist responsibilities.
The cytotechnologist is responsible for documenting--
(a) The slide interpretation results of each gynecologic and
nongynecologic cytology case he or she examined or reviewed (as
specified in Sec. 493.1274(c));
(b) For each 24-hour period, the total number of slides examined or
reviewed in the laboratory as well as the total number of slides
examined or reviewed in any other laboratory or for any other employer;
and
(c) The number of hours spent examining slides in each 24-hour
period.
Sec. 493.1487 Condition: Laboratories performing high complexity
testing; testing personnel.
The laboratory has a sufficient number of individuals who meet the
qualification requirements of Sec. 493.1489 of this subpart to perform
the functions specified in Sec. 493.1495 of this subpart for the volume
and complexity of testing performed.
Sec. 493.1489 Standard; Testing personnel qualifications.
Each individual performing high complexity testing must--
(a) Possess a current license issued by the State in which the
laboratory is located, if such licensing is required; and
(b) Meet one of the following requirements:
(1) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located or have earned
a doctoral, master's or bachelor's degree in a chemical, physical,
biological or clinical laboratory science, or medical technology from an
accredited institution;
(2)(i) Have earned an associate degree in a laboratory science, or
medical laboratory technology from an accredited institution or--
[[Page 982]]
(ii) Have education and training equivalent to that specified in
paragraph (b)(2)(i) of this section that includes--
(A) At least 60 semester hours, or equivalent, from an accredited
institution that, at a minimum, include either--
(1) 24 semester hours of medical laboratory technology courses; or
(2) 24 semester hours of science courses that include--
(i) Six semester hours of chemistry;
(ii) Six semester hours of biology; and
(iii) Twelve semester hours of chemistry, biology, or medical
laboratory technology in any combination; and
(B) Have laboratory training that includes either of the following:
(1) Completion of a clinical laboratory training program approved or
accredited by the ABHES, the CAHEA, or other organization approved by
HHS. (This training may be included in the 60 semester hours listed in
paragraph (b)(2)(ii)(A) of this section.)
(2) At least 3 months documented laboratory training in each
specialty in which the individual performs high complexity testing.
(3) Have previously qualified or could have qualified as a
technologist under Sec. 493.1491 on or before February 28, 1992;
(4) On or before April 24, 1995 be a high school graduate or
equivalent and have either--
(i) Graduated from a medical laboratory or clinical laboratory
training program approved or accredited by ABHES, CAHEA, or other
organization approved by HHS; or
(ii) Successfully completed an official U.S. military medical
laboratory procedures training course of at least 50 weeks duration and
have held the military enlisted occupational specialty of Medical
Laboratory Specialist (Laboratory Technician);
(5)(i) Until September 1, 1997--
(A) Have earned a high school diploma or equivalent; and
(B) Have documentation of training appropriate for the testing
performed before analyzing patient specimens. Such training must ensure
that the individual has--
(1) The skills required for proper specimen collection, including
patient preparation, if applicable, labeling, handling, preservation or
fixation, processing or preparation, transportation and storage of
specimens;
(2) The skills required for implementing all standard laboratory
procedures;
(3) The skills required for performing each test method and for
proper instrument use;
(4) The skills required for performing preventive maintenance,
troubleshooting, and calibration procedures related to each test
performed;
(5) A working knowledge of reagent stability and storage;
(6) The skills required to implement the quality control policies
and procedures of the laboratory;
(7) An awareness of the factors that influence test results; and
(8) The skills required to assess and verify the validity of patient
test results through the evaluation of quality control values before
reporting patient test results; and
(ii) As of September 1, 1997, be qualified under
Sec. 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals
qualified under paragraph (b)(5)(i) of this section who were performing
high complexity testing on or before April 24, 1995;
(6) For blood gas analysis--
(i) Be qualified under Sec. 493.1489(b)(1), (b)(2), (b)(3), (b)(4),
or (b)(5);
(ii) Have earned a bachelor's degree in respiratory therapy or
cardiovascular technology from an accredited institution; or
(iii) Have earned an associate degree related to pulmonary function
from an accredited institution; or
(7) For histopathology, meet the qualifications of Sec. 493.1449 (b)
or (l) to perform tissue examinations.
[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5236, Jan. 19, 1993; 58
FR 39155, July 22, 1993; 60 FR 20050, Apr. 24, 1995]
Sec. 493.1491 Technologist qualifications on or before February 28,
1992.
In order to qualify as high complexity testing personnel under
Sec. 493.1489(b)(3), the individual must have met or could have met the
following qualifications for technologist as they were in effect on or
before February 28, 1992. Each technologist must--
[[Page 983]]
(a) Possess a current license as a laboratory technologist issued by
the State, if such licensing exists; and
(b)(1) Have earned a bachelor's degree in medical technology from an
accredited university; or
(2) Have successfully completed 3 years of academic study (a minimum
of 90 semester hours or equivalent) in an accredited college or
university, which met the specific requirements for entrance into a
school of medical technology accredited by an accrediting agency
approved by the Secretary, and has successfully completed a course of
training of at least 12 months in such a school; or
(3) Have earned a bachelor's degree in one of the chemical,
physical, or biological sciences and, in addition, has at least 1 year
of pertinent full-time laboratory experience or training, or both, in
the specialty or subspecialty in which the individual performs tests; or
(4)(i) Have successfully completed 3 years (90 semester hours or
equivalent) in an accredited college or university with the following
distribution of courses--
(A) For those whose training was completed before September 15,
1963. At least 24 semester hours in chemistry and biology courses of
which--
(1) At least 6 semester hours were in inorganic chemistry and at
least 3 semester hours were in other chemistry courses; and
(2) At least 12 semester hours in biology courses pertinent to the
medical sciences; or
(B) For those whose training was completed after September 14, 1963.
(1) 16 semester hours in chemistry courses that included at least 6
semester hours in inorganic chemistry and that are acceptable toward a
major in chemistry;
(2) 16 semester hours in biology courses that are pertinent to the
medical sciences and are acceptable toward a major in the biological
sciences; and
(3) 3 semester hours of mathematics; and
(ii) Has experience, training, or both, covering several fields of
medical laboratory work of at least 1 year and of such quality as to
provide him or her with education and training in medical technology
equivalent to that described in paragraphs (b)(1) and (2) of this
section; or
(5) With respect to individuals first qualifying before July 1,
1971, the technologist--
(i) Was performing the duties of a laboratory technologist at any
time between July 1, 1961, and January 1, 1968, and
(ii) Has had at least 10 years of pertinent laboratory experience
prior to January 1, 1968. (This required experience may be met by the
substitution of education for experience); or
(6) Achieves a satisfactory grade in a proficiency examination
approved by HHS.
[58 FR 39155, July 22, 1993]
Sec. 493.1495 Standard; Testing personnel responsibilities.
The testing personnel are responsible for specimen processing, test
performance and for reporting test results.
(a) Each individual performs only those high complexity tests that
are authorized by the laboratory director and require a degree of skill
commensurate with the individual's education, training or experience,
and technical abilities.
(b) Each individual performing high complexity testing must--
(1) Follow the laboratory's procedures for specimen handling and
processing, test analyses, reporting and maintaining records of patient
test results;
(2) Maintain records that demonstrate that proficiency testing
samples are tested in the same manner as patient specimens;
(3) Adhere to the laboratory's quality control policies, document
all quality control activities, instrument and procedural calibrations
and maintenance performed;
(4) Follow the laboratory's established policies and procedures
whenever test systems are not within the laboratory's established
acceptable levels of performance;
(5) Be capable of identifying problems that may adversely affect
test performance or reporting of test results and either must correct
the problems or immediately notify the general supervisor, technical
supervisor, clinical consultant, or director;
[[Page 984]]
(6) Document all corrective actions taken when test systems deviate
from the laboratory's established performance specifications; and
(7) Except as specified in paragraph (c) of this section, if
qualified under Sec. 493.1489(b)(5), perform high complexity testing
only under the onsite, direct supervision of a general supervisor
qualified under Sec. 493.1461.
(c) Exception. For individuals qualified under Sec. 493.1489(b)(5),
who were performing high complexity testing on or before January 19,
1993, the requirements of paragraph (b)(7) of this section are not
effective, provided that all high complexity testing performed by the
individual in the absence of a general supervisor is reviewed within 24
hours by a general supervisor qualified under Sec. 493.1461.
[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5236, Jan. 19, 1993; 60
FR 20050, Apr. 24, 1995]
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