Amy,
CLIA 88 Guidelines will answer your questions, but here are some PDFs that may
helpful as well. Certifications are not listed in the CLIA guidelines, but
educational achievements (e.g. degrees earned and/or college credits earned in
specific disciplines may qualify an individual).
http://www.jointcommission.org/assets/1/18/clia_required_personnel_qualifications.pdf
http://www.cap.org/ShowProperty?nodePath=/UCMCon/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2014/TLTM/TLTM_Preinsp_personnelrequirementsbytestingcomplexity.pdf
CFR > Title 42 > Chapter IV > Subchapter G > Part 493 > Subpart M > Section
493.1489
42 CFR 493.1489 - Standard; Testing personnel qualifications.
eCFR
Authorities (U.S. Code)
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§ 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 -
(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 §
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 § 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 § 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
