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Centers for Medicare & Medicaid Services, 
Department of Health and Human Services
Attention: CMS–3326–NC
P.O. Box 8016
Baltimore, MD 21244–8016

������ý (ASM) is pleased to have the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) request for information on “Revisions to Personnel Regulations, Proficiency Testing Referral, Histocompatibility Regulations and Fee Regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).” We wrote in August, 2016 asking for clarification of the  and appreciate the opportunity to comment on the educational requirements for moderate and high complexity testing personnel under CLIA and proficiency testing referral.

Personnel Testing 

We strongly disagree with the statement that “a bachelor’s degree in nursing… [is] equivalent to a bachelor’s degree in biological science for purposes of the educational requirements for moderate and high complexity testing personnel under CLIA.” Our position is supported by the personnel standards for moderate complexity testing (493.1423) and high complexity testing (493.1489). While nursing curricula may meet the specifications for ‘natural health science’, they do not meet the laboratory requirements of ‘biological science’. Note that high complexity testing requires 24 semester hours of science that include six hours of chemistry, six hours of biology, and 12 hours of chemistry, biology, or medical laboratory technology in any combination. Review of several available nursing curricula indicates that many of them fall short of the 24 semester hours required in science majors (chemistry, biology, medical laboratory, etc.), when compared to the clinical laboratory science degrees, which require >60 semester hours in these disciplines. ASM strongly recommends that all laboratory testing personnel meet the 24 hour semester hour science requirement at a minimum and maintain certification and recertification in the respective disciplines. Further, all individuals must have a thorough understanding of pre-analytical, analytical and post-analytical aspects of laboratory testing. Testing personnel must meet stringent competency and proficiency challenges prior to implementation of testing and demonstrate continuous proficiency at prescribed intervals to maintain this proficiency. Finally, continuing education in the field of laboratory science must be documented on an ongoing basis to meet the regulatory requirements for credentialing. Even with these requirements in place, some laboratory errors continue to occur; without these safeguards in place for non-laboratory personnel, we fear the error rates would rise significantly and compromise patient care.

Certification by the American Society for Clinical Pathology (ASCP) the American Medical Technologists (AMT) and the AAB Board of Registry (ABOR) is widely accepted and often required in the moderate and high complexity laboratory setting. Eleven states and Puerto Rico now require licensure, all but one recognize national certification examinations to qualify personnel. An unpublished 2016 American Society for ������ý survey of 243 microbiologists directing high-complexity, CLIA-credentialed laboratories was conducted to determine personnel requirements for bench staff. When asked requirements at their institution at time of hire or within 2 years of hire, 63% indicated a requirement for ASCP certification, 30% indicated state licensure, 22% AMT certification, and 7.4% American Association of Bioanalysts (AAB) certification. Recognizing value in certification and licensure, the clinical laboratory industry and states have been self-regulating. To our knowledge, no adjunct certification exists specifically for nurses to perform clinical laboratory tests.

ASM acknowledges and applauds the nursing profession for their dedication to direct patient care that is reflected in their training however, it is a different perspective and not equivalent to a degree in biological science.

Proficiency Testing 

ASM acknowledges the Taking Essential Steps for Testing Act (TEST) of 2012 gives CMS greater latitude in review and sanctions for violation of proficiency testing (PT) challenges. ASM strongly supports the independent testing of proficiency testing challenges and adheres to the strict code that they be processed and analyzed as per routine patient samples and not sent to a referral laboratory. The blatant referral of a PT sample from a laboratory to a reference laboratory for identification should be a sanctionable offense.

When following CLIA expectations to maintain anonymity of a PT sample, several situations may arise that necessitate consideration, so as not to violate the integrity of the process. For example the following situations:

• when a multi- hospital or laboratory system performs PT at each site and is directed by a single Director, who serves as the referring consultant; or
   
• when routine operating procedures dictate that a specimen meeting designated criteria be sent out to a reference laboratory; or
   
• when a PT sample is referred internally within a local system to more than one laboratory area with different addresses

Special procedures and safeguards must be in place so as to avoid bias and unintended violations. ASM suggests several solutions for the latter scenarios.

• Identify the individual (s) responsible for maintaining the process and establish means to safeguard against violations, such as:
   
• Identifying the samples as proficiency testing samples and maintain compliance per laboratory policy for processing and work-up with a ‘no referral’ policy.
   
• Use of “mock patient” identifiers (in the laboratory’s LIS system), and establishing a system that designates these as ‘non-referral’.

The ASM represents over 30,000 microbiologists professionally employed in a variety of settings related to the microbial sciences and many 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 firmly reject nursing degrees as equivalent to clinical laboratory science degrees and urge rules for proficiency testing that allow laboratories to avoid unintended violations.

Again, thank you for the opportunity to comment on these critical issues.

Yours truly,

Peggy Cotter, Ph.D., President, American Society for ������ý
Stefano Bertuzzi, Ph.D., M.P.H., CEO, American Society for ������ý
Ronald M. Atlas, Ph.D., Chair, ASM Public and Scientific Affairs Board
Robert Jerris, Ph.D., D(ABMM), Chair, Professional Affairs Committee
Paula Revell, Ph.D., D(ABMM), Chair, Committee on Laboratory Practices