Phlebotomy licensure in the United States

Phlebotomy licensure in the United States is the process by which various regulatory bodies regulate the practice of phlebotomy through licensure. There are no federal phlebotomy training or certification requirements, though several states have imposed their own requirements. In 2024, four states require licensure for phlebotomy: California, Louisiana, Nevada, and Washington.

In 2001, California enacted phlebotomy licensure after an on-the-job trained phlebotomist was found to be re-using needles. Following California, several states including Massachusetts and Missouri attempted to introduce either licensure or training/educational requirements, but the bills died.[1][2][3]

Phlebotomy licensure advocates claim that the licensure would enhance the quality of personnel, while the laboratory industry opposes phlebotomy licensure as an unnecessary cost.[4][5][6] Phlebotomy is not without risk, and more challenging patients increase the chance of complications.[7] However, without licensure, it can be difficult to hold bad actors accountable. Nonphysician healthcare personnel, including phlebotomists, may be sued due to poor practice standards.[8]

Increasingly, a number of healthcare facilities are rolling phlebotomy duties into their patient care technician roles or other allied health roles.[9][5]

A number of FDA 510k cleared devices, such as the BD Minidraw have been introduced to enable the drawing of blood without a phlebotomist.[10] Additionally, there are devices to help aid non-phlebotomists more readily find veins.[11]

Certifications

There are several national phlebotomy certifications in the US.[12][13][14]

List of Phlebotomy Certifications in the United States
Abbr Phlebotomy Certifying Agency Certification Designation Notes
AAH American Allied Health Certified Phlebotomy Technician CPT (AAH)
ACA American Certification Agency for Healthcare Professionals Certified Phlebotomy Technician CPT(ACA)
AECA American Education Certification Association Certified Phlebotomy Technician Specialist CPTS (AECA)
AMCA American Medical Certification Association PTC (AMCA)
AMT American Medical Technologists Register Phlebotomy Technician RPT(AMT)
ASCP American Society for Clinical Pathology Phlebotomy Technician PBT(ASCP)
ASPT American Society of Phlebotomy Technicians Certified Phlebotomy Technician CPT(ASPT)
IAPA
NCA National Credentialing Agency for Laboratory Personnel CLPlb(NCA)
NCCT/MMCI National Center for Competency Testing National Certified Phlebotomy Technician NCPT(NCCT)
NHA National Healthcareer Association Certified Phlebotomy Technician CPT(NHA)
NAHP National Association for Health Professionals National Registered Certified Phlebotomy Technician NRCPT(NAHP)
NPA National Phlebotomy Association Certified Phlebotomy Technician CPT(NPA)
NPCE National Phlebotomy Certification Examination Phlebotomy Technician
NPS National Performance Specialist Certified Phlebotomy Technician

States

California

In 2001, California enacted phlebotomy licensure following a public health outcry about an on-the-job trained phlebotomist that re-used needles.[15][16]

California has two levels of phlebotomy licensure:

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.[19][20][21] The laboratory conducted an internal review of its phlebotomy practices at its 800 sites across the United States and found no deficiencies.[22] 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.[23][24][25] A subsequent study found a low risk of infection from the re-used needles due to the low infection prevalence in Palo Alto.[26]

Connecticut

In 2005, a bill was introduced requiring 80 hours of training and certification of phlebotomists, but was not passed.[2]

District of Columbia

In 2014, DC passed Law 20-272, Clinical Laboratory Practitioners Amendment Act of 2014 which established a registration board for phlebotomists.[27][28]

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.[29]

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.[30][31][32]

There have been bills to introduce phlebotomy licensure in Illinois, but have been unsuccessful.[33]

Kentucky

In 2005, a bill was introduced that would require 80 hours of didactic and practical training, plus 50 hours of clinical training, and certification as a phlebotomy technician for phlebotomy, that did not pass.[2]

Louisiana

Massachusetts

In 2007, a bill (HR 312) was introduced to establish a board of registration of phlebotomists, but did not pass.[2][1][34]

Missouri

In 2008, a bill to license medical technologists and phlebotomists was introduced, but did not pass.[2]

Nevada

North Carolina

North Carolina does not have any additional state requirements for phlebotomy.[35]

Washington

West Virginia

In 1999, a bill was introduced that would require phlebotomists be certified, but it died in committee.[2]

Further reading

  • Edwards, Mac (Oct 2005). "Coalition strives for phlebotomy personnel standards". Medical Laboratory Observer. 37 (10): 24–5, 28. PMID 16295181. Gale A138320595.

References

  1. ^ a b Ernst, Dennis (October 2009). "Phlebotomy certification legislation: update on three of our 50 states". Medical Laboratory Observer. 41 (10): 42. PMID 19891151. Gale A210847808. Retrieved 17 February 2024.
  2. ^ a b c d e f Ernst, DJ (July 2008). "States fail to follow California's lead in certifying phlebotomists". Medical Laboratory Observer. 40 (7): 40, 42. PMID 18717500. Gale A182040780.
  3. ^ Kwan, H (October 2008). "Rooster guarding hen house?". Medical Laboratory Observer. 40 (10): 6, 8. PMID 18990788.
  4. ^ Mishori, Ranit (May 31, 2004). "Drawing Without a License". Washington Post. Retrieved 17 February 2024.
  5. ^ a b "Should non-phlebotomists be allowed to draw blood?". Clinical Leadership & Management Review. 15 (6): 426–8. November 2001. PMID 11822275.
  6. ^ 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.
  7. ^ Harty-Golder, Barbara (January 2003). "When should a phlebotomist ask for help with a difficult draw?". MLO: Medical Laboratory Observer. 35 (1): 48. PMID 12561745. Gale A96892952.
  8. ^ Flynn, John C. (9 August 2013). "Medical-Legal Issues and Health Law Procedures". Procedures in Phlebotomy. Elsevier Health Sciences. p. 180. ISBN 978-0-323-27709-9. Retrieved 19 August 2024.
  9. ^ Ernst, DJ (October 1997). "Is the phlebotomist obsolete?". MLO: Medical Laboratory Observer. 29 (10): 30–4. PMID 10173584. Gale A20076530.
  10. ^ Dharma, RanjithKumar (8 December 2023). "BD receives clearance for new blood collection device". Medical Device Network. Retrieved 30 April 2024.
  11. ^ "Vein attempts? Making needles easier to bear". Orange County Register. 14 September 2007. Retrieved 30 April 2024.
  12. ^ McCall, Ruth E.; Tankersley, Cathee M. (2008). Phlebotomy Exam Review. Lippincott Williams & Wilkins. ISBN 978-0-7817-7855-8.
  13. ^ 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.
  14. ^ 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.
  15. ^ "California to require certification for technicians who draw blood". AIDS Policy & Law. 14 (20): 11. 29 October 1999. PMID 11367053.
  16. ^ "Proposed law would beef up phlebotomy training: Training can't prevent irresponsibility". Hospital Infection Control & Prevention. June 1, 1999.
  17. ^ "Phlebotomy Technician I (CPT I) Certificate". CDPH LFS. January 29, 2024. Retrieved 30 April 2024.
  18. ^ "Phlebotomy Technician II (CPT II) Certificate". CDPH LFS. January 29, 2024. Retrieved 30 April 2024.Public Domain This article incorporates text from this source, which is in the public domain.
  19. ^ "Lab Worker Arrested for Reusing Needles". Los Angeles Times. 5 March 2000. Retrieved 17 February 2024.
  20. ^ "Reuse of Needles at Clinic Yields 1-Year Term". Los Angeles Times. 17 August 2002. Retrieved 17 February 2024.
  21. ^ Hawkes, Alison (1 December 2000). "Final arguments heard in needle re-using nurse's trial". San Mateo Daily Journal. Retrieved 17 February 2024.
  22. ^ Lite, Jordan (18 April 1999). "Palo Alto Blood-Test Worker Caught Reusing Needles". Los Angeles Times. Retrieved 17 February 2024.
  23. ^ 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)
  24. ^ Michel, Robert (7 June 1999). "Palo Alto Needle Reuse Episode Widens in Scope". The Dark Report. VI (8).
  25. ^ Michel, Robert (9 August 1999). "California Assesses Fines After Needle Reuse by SBCL Employee". The Dark Report. VI (11).
  26. ^ 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.
  27. ^ "§ 3–1209.12. Phlebotomist. | D.C. Law Library". code.dccouncil.us. Retrieved 30 April 2024.
  28. ^ "Act 20-618, Clinical Laboratory Practitioners Amendment Act of 2014". dcregs.dc.gov. Retrieved 30 April 2024.
  29. ^ "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.
  30. ^ "Public Act 101-0542". Illinois General Assembly. Dec 1, 2020. Retrieved 17 February 2024.
  31. ^ Wall, Craig (December 19, 2019). "New laws 2020: Illinois laws, fees that take effect January 1". ABC7 Chicago. Retrieved 17 February 2024.
  32. ^ "New Training Requirements Enacted for Phlebotomists". Illinois Health and Hospital Association. October 10, 2019. Retrieved 17 February 2024.
  33. ^ "Illinois General Assembly – Bill Status of HB5011 99th General Assembly". www.ilga.gov.
  34. ^ "An Act Establishing a Board of Registration of Phlebotomists. Bill H.312". malegislature.gov. Retrieved 30 April 2024.
  35. ^ "NC DHSR AHCLCS CLIA: Frequently Asked Questions". North Carolina Division of Health Service Regulation. April 25, 2019. Retrieved 30 April 2024. 2. Does North Carolina have any state licensure for clinical laboratories or laboratory personnel?? No, North Carolina follows the CLIA regulations and does not have separate state licensure requirements for laboratories or laboratory personnel.