Home

Recent News

  • October 27, 2024

    Dr. Biz Fisher DCLS, MHA, CC(NRCC), MLS(ASCP)CM, PBTCM

     

    CLIA Personnel Changes Effective December 28, 2024

          CLIA made personnel changes that will be effective on December 28, 2024.  There are several provisions to grandfather in existing personnel positions, but moving forward laboratories should be mindful of the changes to personnel requirements.  This communication will summarize changes for the high complexity laboratory director (LD) and the high complexity technical supervisor (TS).  The CMS final rule can read in its entirety at the following link, Federal Register.

    High Complexity Laboratory Director

    ·         At § 493.1406 the grandfather provision was removed allowing laboratory directors before February 28, 1992 to remain as qualified laboratory directors.  These individuals no longer qualify under these new revisions.

    ·         At §§ 493.1407(c) and 493.1445(c) the laboratory director must be on site at least every six months with at least 4 months between visits with appropriate documentation. Indiana, Illinois, Michigan, Kentucky, and Ohio do not currently require 6 month on site LD visits.

    ·         The Doctorate of Clinical Laboratory Science (DCLS) is a qualifying doctorate as a high complexity LD.  The Doctor of Veterinary (DVM) is being removed as a qualifying doctorate degree.

    ·         An LD must complete 20 continuing education (CE) credit hours annually relevant to laboratory directorship.

    High Complexity Technical Supervisor

    ·         A new provision, § 493.1449(d), will be added to the technical supervisor qualification section.  The high complexity TS of immunohematology is no longer required to be an MD or DO with appropriate experience and training.  Under the new provision the degree requirements are doctorate, masters, or bachelor’s with appropriate experience and training for immunohematology.

         This opens up career pathways for the medical laboratory scientist (MLS).  An MLS who completes a qualifying doctorate and an HHS approved board certification may be a high complexity laboratory director over a laboratory that provides blood bank services.  Under the current requirements an individual such, as was described, would need to hire a qualifying MD or DO as a TS over the blood bank.  Under the new provisions this is not required.  The LD may now designate the immunohematology TS position to an MLS with a bachelor’s degree or higher with appropriate training and experience.  This eases smaller rural laboratory personnel requirements as well those that do not need a pathologist on site, but are required to employ an LD and a TS. This is also advantageous if the site does not have testing personnel with a bachelor’s degree because the LD may designate themselves as the TS of immunohematology.  Below are the current personnel requirements for high and moderate complexity laboratories:

    High Complexity Laboratories

    Moderate Complexity Laboratories

    ·         Laboratory Director

    ·         Clinical Consultant

    ·         Technical Supervisor

    ·         General Supervisor

    ·         Testing Personnel

    ·         Laboratory Director

    ·         Clinical Consultant

    ·         Technical Consultant

    ·         Testing Personnel

     

     

         These are the minimum personnel requirements and may not be as stringent as those requirements for your organization, state, or accrediting body. 

Follow us on Facebook!!!

Announcements List

No Data Found

Either the content you're seeking doesn't exist or it requires proper authentication before viewing.

News

Action Alert: Urge Members of Congress to Cosponsor the Medical Laboratory Personnel Shortage Relief Acthttps://labvocate.org/action-center/

 

  • Evansville Campus

IU expands Medical Laboratory Scientist program to address national shortage

Aug 14, 2024


Department of Pathology team members celebrate the Medical Laboratory Scientist Program expansion with a ribbon cutting ceremony on August 14. From left to right: program faculty Kevin Beitler, Elizabeth Fisher, and Ifeanyi Udensi; Matthew Kuhar, MD, Vice Chair of Education; Andrea Ligler, Vice Chair for Clinical and Academic Administration; Michael Feldman, MD, PhD, Department of Pathology Chair; Kimberly Shea, Department of Pathology Education Manager; Julie Connor, Department of Pathology Medical Education Coordinator; Nicholas Brehl, MED, Director of the Medical Laboratory Science Program.

EVANSVILLE – Indiana University School of Medicine is expanding its Bachelor of Science Medical Laboratory Scientist Program to the IU School of Medicine Campus in Evansville, Indiana. This initiative is a response to the intensifying national shortage of medical laboratory scientists, which poses a significant threat to the delivery of quality patient care across the United States.

Medical laboratory scientists are essential health care professionals who perform highly complex laboratory tests that inform the diagnosis and treatment of patients. The Bureau of Labor Statistics projects a nationwide need for a 13% increase in medical laboratory technologists and technicians between 2016 and 2026. This increase is nearly twice the national average for all jobs, which highlights the urgent need for more trained professionals in this field.

This expansion is funded through a collaboration between the IU School of Medicine Department of Pathology and Deaconess Health System. The program aims to educate and prepare students to enter this critical profession, thereby increasing the capacity of regional health care partners to provide the best care for patients in the tri-state region.

“Investing in this new program at a time when other similar programs around the country are closing due to funding challenges reflects our strong commitment to improving the health and wellness of the people of Indiana and beyond,” said Matthew Kuhar, MD, Vice Chair for Education in the IU School of Medicine Department of Pathology.

The expanded program will be directed by Nick Brehl, MED, and commence classes in August 2024. The inaugural class has four students, with plans to increase enrollment to 24 students over the next few years. Graduates of the program will be equipped with the knowledge, competencies and professionalism necessary to practice in clinical laboratories and sit for the national certification exam.

"This expansion represents a significant step forward in addressing the critical shortage of Medical Laboratory Scientists,” said James Porter, MD, President of Physician Enterprise at Deaconess. “By increasing our capacity to train new professionals locally, we are not only enhancing the quality of patient care but also contributing to the resilience of our healthcare system."

Students interested in the program can contact Kimberly Shea, education manager for the Department of Pathology and Laboratory Medicine.

About the IU School of Medicine

The IU School of Medicine is the largest medical school in the U.S. and is annually ranked among the top medical schools in the nation by U.S. News & World Report. The school offers high-quality medical education, access to leading medical research and rich campus life in nine Indiana cities, including rural and urban locations consistently recognized for livability. According to the Blue Ridge Institute for Medical Research, the IU School of Medicine ranks No. 13 in 2023 National Institutes of Health funding among all public medical schools in the country.

Writer: Cathy Zimmermann, cjzimmer@iu.edu

Source: Kimberly Shea, kimshea@iu.edu

For more news, visit the IU School of Medicine Newsroom: medicine.iu.edu/news