Request for Public Comment for Transitioning Phlebotomy and Clinical Assistant Programs to Accredited Status

(Last Updated On: December 4, 2020)

The NAACLS Board of Directors is considering transitioning approved programs to accredited programs and phasing out the term “approved”. Over the past three years, the NAACLS Program Approval Review Committee (PARC) has engaged in internal discussions regarding the definition and challenges of the term “approval.” Discussions were initially stimulated by approved programs that wished to have a NAACLS site visit. Recently the PARC considered the challenges that hospital-based approved programs have securing Medicare funding for students stemming from not being “accredited” by NAACLS. A task force made of PARC members met to discuss both broader conceptual reasons as well as detailed operational ramifications of transitioning phlebotomy and clinical assistant programs to a review process consistent with NAACLS accredited programs. The task force, and PARC at large, tried to consider the matter from all angles.

It is essential to consider that phlebotomy and clinical assistant programs go through a peer-review process, administered by content experts, and held to a set of standards. In essence, this process is what describes accreditation. NAACLS elected to label this process as approval for phlebotomy and clinical assistant programs. While the reasoning of why NAACLS started using the term “approval” is unclear now, what is clear is the term leads to confusion by the public, frustration by the Council of Higher Education and Accreditation (NAACLS’ recognition agency), and presents unnecessary boundaries to program directors.

The NAACLS Board of Directors is considering transitioning approved phlebotomy and clinical assistant programs from their current quality assurance process (the review process consisting of only a self-study with a five-year maximum award for programs) to a quality assurance process consistent with the disciplines that NAACLS accredits (a review process requiring a self-study and site visit with a ten-year maximum award).

Primary Reasons for Recommendation

Universal Recognition of Accreditation

It is critical to NAACLS’ mission that clarity about which programs have successfully met the NAACLS standards is readily available to the public. Equally important is to employ terminology with widely understood, labels that are meaningful to educators, students, laboratory managers, governmental agencies, and other stakeholders. For example, a phlebotomy program advertising that it is “approved” by NAACLS does not carry the same widely understood recognition as “accreditation,” even if the quality assurance process is essentially identical.

With a wide variety of phlebotomy and clinical assistant programs available to prospective students, quality indicators are essential. When a prospective student searches for quality phlebotomy and clinical assistant programs, the search is likely based on the term accreditation. The label “approval” in quality assurance is unfamiliar to educators and programmatic accreditor colleagues.

Medicare Reimbursement

NAACLS’ approved phlebotomy and clinical assistant programs and students are not, under the current terminology, eligible for federal funds. The federal regulation provides training cost reimbursement for hospital-based programs: 42 CFR 413.85 Cost of approved nursing and allied health education activities. Programs must meet specific criteria to qualify.

From the Centers for Medicare & Medicaid Services (CMS) Code of Federal Regulations:

§ 413.85 Cost of approved nursing and allied health education activities.

(a) Statutory basis. This section implements section 1861 (v)(1)(A) of the Act and section 4004(b) of the Omnibus Budget Reconciliation Act of 1990 (Public Law 101-508) by establishing the methodology for Medicare payment of the costs of approved nursing and allied health education activities.

(b) Scope.

(1) This Section sets fort the rules for determining Medicare payments to hospitals for the costs of nursing and allied health education activities.

Teaching hours are reimbursable from CMS the for allied health education programs that meet the criteria.

PARC members have practical experience in working with the CMS to demonstrate that NAACLS approved programs complete a recognized quality assurance process. Despite these efforts, NAACLS approved programs, to this date, have not qualified for Medicare reimbursement as these programs are not understood to be accredited.

Public Comment

The NAACLS Board of Directors discussed transitioning phlebotomy and clinical assistant program programs from approved to accredited at the September 2020 Board of Directors’ meeting. As this would be a significant change to NAACLS’ policy and procedure, the Board is requesting public comment on the potential change.

Please submit all comments on the change to Mark Spence ( by January 15th, 2020.

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