°®¶¹´«Ã½

Mr. Thomas E. Hamilton
Director, Survey and Certification Group
Centers for Medicare and Medicaid
7500 Security Boulevard
Mailstop C2-21-16
Baltimore, MD, 21244-1850

Dear Mr. Hamilton:

RE: Memorandum (S&C -16-18-CLIA)

The American Society of °®¶¹´«Ã½ (ASM) is writing to address the April 1 Memorandum (S&C-16-18-CLIA) from the Centers for Medicare and Medicaid to State Survey Agency Directors (CLIA). There are two statements in the document which seem contradictory, so we are requesting clarification. In the Memorandum Summary, it states:

• CLIA personnel regulations and the policy on mandatory citations are not changing.
• Bachelor’s and Associate’s degrees in nursing meet the requirement for earning a degree in a biological science for, respectively, high complexity testing personnel and moderate complexity testing personnel.

We are writing to gain clarity whether this is a change in testing personnel qualifications as stated in policy 42 CFS 493.1489 (high complexity) and 42 CFS 493.1423 (moderate complexity), as it denotes nursing as a unique entity and equivalent to associate’s or bachelor’s degrees in biological sciences for the purpose of performing non-waived (moderate and/or high complexity) testing. From our reading of the Personnel Standards, below, most nursing curriculum do not meet the specifications and are geared toward ‘natural science’ directed for patient care and not ‘biological science’.

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.

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.

The Society represents approximately 41,000 microbiologists professionally employed in a variety of settings related to the microbial sciences. Many of ASM members are involved in clinical laboratory medicine. These individuals direct clinical microbiology, immunology, and molecular diagnostic laboratories, are licensed or accredited to perform such testing, are industry representatives developing products for use, or are researchers involved in pre-market testing of laboratory diagnostics.ASM also includes clinician members involved in infectious disease prevention and management. As our clinical members are committed to providing healthcare of the highest quality, we look forward to the clarification of this issue.

Yours truly,

Susan E. Sharp, Ph.D., D(ABMM), FAAM, President, American Society for °®¶¹´«Ã½
Stefano Bertuzzi, Ph.D., M.P.H., CEO, American Society for °®¶¹´«Ã½
Ronald M. Atlas, Ph.D., Chair, ASM Public and Scientific Affairs Board
Robert Jerris, Ph.D., D(ABMM), Chair, Professional Affairs Committee

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