Phlebotomy licensure

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Phlebotomy licensure is the process by which various regulatory bodies regulate the practice of phlebotomy within its jurisdiction through licensure. In many countries a license is not required, or is obtained through other broader qualifications (such as a medical license), while in others, professional phlebotomists are separately licensed.

In most countries, there is not a dedicated a profession to phlebotomy, but it falls under the responsibility of other allied health professions such as nursing.[1][2][3]

Asia

China

In China, there are no national phlebotomy regulations, and phlebotomy is primarily performed by nurses, though Chinese nursing education offers limited training in phlebotomy quality control. [4]

Europe

United Kingdom

Phlebotomists need not by licenced in the UK, but training can be provided on-the-job, sometimes with the support of the National Association of Phlebotomists.[5] The skills required may also be monitored through broader monitoring requirements, such as the licence to practice of the General Medical Council.

North America

United States

In the United States, four states require licensure for phlebotomy: California, Louisiana, Nevada, Washington. There are no federal phlebotomy training or certification requirements, though several states have imposed their own requirements.

California introduced phlebotomy licensure after an on-the-job trained phlebotomist at a Palo Alto phlebotomy draw station for SmithKline Beecham Clinical Laboratory (SBCL) was found to be re-using needles, sometimes after washing them with diluted hydrogen peroxide, in an effort to save supplies and run a cost-efficient lab. The phlebotomist was also accused of mislabeling blood to cover-up mistakes, of reusing the same pipette for both blood and urine samples and of rarely wearing rubber gloves while working.[6][7][8] The laboratory conducted an internal review of its phlebotomy practices at its 800 sites across the United States and found no deficiencies.[9] The California Department of Public Health (CDPH) advised the approximately 3600 impacted patients whom had their blood drawn at the clinic to get HIV and Hepatitis testing as well as counseling.[10][11][12]A subsequent study found a low risk of infection from the re-used needles due to the low infection prevalence in Palo Alto.[13]

Following California, several states including Massachusetts and Missouri attempted to introduce either licensure or training/educational requirements, but the bills died.[14][15][16]

Phlebotomy licensure advocates claim that the licensure would enhance the quality of personnel, while the laboratory industry opposes phlebotomy licensure as an unnecessary cost.[17][18][19]

Certifications

There are several national phlebotomy certifications in the US.[20][21][22]

Abbr Phlebotomy Certifying Agency Certification Designation Notes
AAH American Allied Health CPT (AAH)
ACA American Certification Agency for Healthcare Professionals CPT(ACA)
AMCA American Medical Certification Association PTC (AMCA)
AMT American Medical Technologists RPT(AMT)
ASCP American Society for Clinical Pathology PBT(ASCP)
ASPT American Society of Phlebotomy Technicians CPT(ASPT)
IAPA
NCA National Credentialing Agency for Laboratory Personnel CLPlb(NCA)
NCCT/MMCI National Center for Competency Testing NCPT(NCCT)
NHA National Healthcareer Association CPT(NHA)
NAHP National Association for Health Professionals NRCPT(NAHP)
NPA National Phlebotomy Association CPT(NPA)

States

California

In 2001, California enacted phlebotomy licensure following a public health outcry about an on-the-job trained phlebotomist that re-used needles.[23][24]

Illinois

Phlebotomists are not licensed in Illinois but must have a high school diploma and have completed a training program to practice. Certification is not required and phlebotomists do not fall under the Illinois Clinical Laboratory Act.[25]

In 2020, Illinois passed a bill requiring the Illinois Department of Public Health to triannually develop training materials for drawing blood from children and adults with intellectual and developmental disabilities and for facilities to ensure the training is incorporated for phlebotomists.[26][27][28]

There have been bills to introduce phlebotomy licensure in Illinois, but have been unsuccessful.[29]

Louisiana

Nevada

Washington

References

  1. ^ Mbah, Henry A. (4 April 2014). "Phlebotomy and quality in the African laboratory". African Journal of Laboratory Medicine. 3 (1). doi:10.4102/ajlm.v3i1.132. PMID 29043181.
  2. ^ Simundic, Ana-Maria; Cornes, Michael; Grankvist, Kjell; Lippi, Giuseppe; Nybo, Mads; Kovalevskaya, Svjetlana; Sprongl, Ludek; Sumarac, Zorica; Church, Stephen (1 August 2013). "Survey of national guidelines, education and training on phlebotomy in 28 European countries: an original report by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group for the preanalytical phase (WG-PA)". Clinical Chemistry and Laboratory Medicine (CCLM). 51 (8): 1585–1593. doi:10.1515/cclm-2013-0283. PMID 23729577.
  3. ^ Simundic, Ana-Maria (14 August 2015). "2.9 Who is Doing Phlebotomy in Europe?". Pre-Examination Procedures in Laboratory Diagnostics. pp. 90–94. doi:10.1515/9783110334043-015. ISBN 978-3-11-033165-3.
  4. ^ Cai, Qian; Zhou, Yunxian; Yang, Dangan (15 February 2018). "Nurses' knowledge on phlebotomy in tertiary hospitals in China: a cross-sectional multicentric survey". Biochemia Medica. 28 (1): 010703. doi:10.11613/BM.2018.010703. PMC 5701774. PMID 29187796.
  5. ^ "National Association of Phlebotomists". Retrieved 5 March 2024.
  6. ^ "Lab Worker Arrested for Reusing Needles". Los Angeles Times. 5 March 2000. Retrieved 17 February 2024.
  7. ^ "Reuse of Needles at Clinic Yields 1-Year Term". Los Angeles Times. 17 August 2002. Retrieved 17 February 2024.
  8. ^ Hawkes, Alison (1 December 2000). "Final arguments heard in needle re-using nurse's trial". San Mateo Daily Journal. Retrieved 17 February 2024.
  9. ^ Lite, Jordan (18 April 1999). "Palo Alto Blood-Test Worker Caught Reusing Needles". Los Angeles Times. Retrieved 17 February 2024.
  10. ^ Writer, Chuck Squatriglia, Chronicle Staff. "Phlebotomist Held in Year-Old Needles Case / Palo Alto lab worker had acknowledged reusing medical equipment". SFGATE.{{cite news}}: CS1 maint: multiple names: authors list (link)
  11. ^ Michel, Robert (7 June 1999). "Palo Alto Needle Reuse Episode Widens in Scope". The Dark Report. VI (8).
  12. ^ Michel, Robert (9 August 1999). "California Assesses Fines After Needle Reuse by SBCL Employee". The Dark Report. VI (11).
  13. ^ Porco, T. C.; Aragón, T. J.; Fernyak, S. E.; Cody, S. H.; Vugia, D. J.; Katz, M. H.; Bangsberg, D. R. (1 April 2001). "Risk of infection from needle reuse at a phlebotomy center". American Journal of Public Health. 91 (4): 636–638. doi:10.2105/ajph.91.4.636. PMC 1446637. PMID 11291380.
  14. ^ Ernst, Dennis (October 2009). "Phlebotomy certification legislation: update on three of our 50 states". Medical Laboratory Observer. 41 (10): 42. PMID 19891151. Retrieved 17 February 2024.
  15. ^ Ernst, DJ (July 2008). "States fail to follow California's lead in certifying phlebotomists". Medical Laboratory Observer. 40 (7): 40, 42. PMID 18717500.
  16. ^ Kwan, H (October 2008). "Rooster guarding hen house?". Medical Laboratory Observer. 40 (10): 6, 8. PMID 18990788.
  17. ^ Mishori, Ranit (May 31, 2004). "Drawing Without a License". Washington Post. Retrieved 17 February 2024.
  18. ^ "Should non-phlebotomists be allowed to draw blood?". Clinical Leadership & Management Review. 15 (6): 426–8. November 2001. PMID 11822275.
  19. ^ Becan-McBride, Kathleen (1 October 2009). "Phlebotomy Errors Point to Need for Mandatory Licensure of Pre-analytical Laboratory Staff". Critical Values. 2 (4): 18–19. doi:10.1093/criticalvalues/2.4.18.
  20. ^ McCall, Ruth E.; Tankersley, Cathee M. (2008). Phlebotomy Exam Review. Lippincott Williams & Wilkins. ISBN 978-0-7817-7855-8.
  21. ^ Strasinger, Susan King; Lorenzo, Marjorie Schaub Di (25 February 2019). The Phlebotomy Textbook. F.A. Davis. pp. 11–12. ISBN 978-0-8036-9012-7.
  22. ^ Niedzwiecki, Brigitte (21 October 2021). Kinn's Medical Assisting Fundamentals - E-Book: Kinn's Medical Assisting Fundamentals - E-Book. Elsevier Health Sciences. p. 1124. ISBN 978-0-323-82454-5.
  23. ^ "California to require certification for technicians who draw blood". AIDS Policy & Law. 14 (20): 11. 29 October 1999. PMID 11367053.
  24. ^ "Proposed law would beef up phlebotomy training:Training can't prevent irresponsibility". Hospital Infection Control & Prevention. June 1, 1999.
  25. ^ "Department of Public Health Frequently Asked Questions". dph.illinois.gov. Retrieved 17 February 2024. Is a phlebotomist required to have a CLIA certificate and license in Illinois? No. Phlebotomists are not required to be licensed in Illinois or have a CLIA certificate to draw blood samples; however, a phlebotomist must have a high school diploma or higher education with documentation that the individual has completed a training program for proper patient care in blood drawing. Training as established in writing by the facility medical director or completion of a training program by a certified training institution.
  26. ^ "Public Act 101-0542". Illinois General Assembly. Dec 1, 2020. Retrieved 17 February 2024.
  27. ^ Wall, Craig (December 19, 2019). "New laws 2020: Illinois laws, fees that take effect January 1". ABC7 Chicago. Retrieved 17 February 2024.
  28. ^ "New Training Requirements Enacted for Phlebotomists". Illinois Health and Hospital Association. October 10, 2019. Retrieved 17 February 2024.
  29. ^ "Illinois General Assembly – Bill Status of HB5011 99th General Assembly". www.ilga.gov.
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