[Histonet] Who can perform high complexity testing

[Walter Benton]

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)
What Cites Me
prev | next
§ 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 qualifications of § 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]


Walter Benton HT(ASCP)QIHC
Lab Operations Manager
Chesapeake Urology Associates
806 Landmark Drive, Suite 127
Glen Burnie, MD 21061
410-768-5961 (Lab)
Chesapeakeurology.com

Voted a Best Place to Work by
Baltimore and Modern Healthcare
Magazines.


-----Original Message-----
From: Amy Johnson via Histonet [mailto:histonet at lists.utsouthwestern.edu]
Sent: Thursday, August 03, 2017 2:28 PM
To: histonet at lists.utsouthwestern.edu
Subject: [Histonet] Who can perform high complexity testing

What kind of credentials does one need to perform High Complexity testing?  My understanding was if you had a 4 year degree of some kind (with some science/biology background) you are qualified to perform these types of tests.  Others have said if you don't have a degree but have your certification as a HT or MLT you are qualified as well........

Thanks for clarifying,

Amylin Johnson, B.S. HTL(ASCP)
Associates in Pathology
Wausau Wi 54401
715-847-2130

_______________________________________________
Histonet mailing list
Histonet at lists.utsouthwestern.edu
http://lists.utsouthwestern.edu/mailman/listinfo/histonet
CONFIDENTIALITY NOTICE: The information contained in this electronic message is intended solely for the personal and confidential use of the designated recipient(s) named above and may contain information that is protected from disclosure under applicable law. If you are not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution or copying of this transmission is strictly prohibited. If you have received this transmission in error, please notify the transmitting person/department immediately by email or telephone (410) 581-5881 and delete the message without making a copy.