Phlebotomy licensure in the United States explained

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 Certified Phlebotomy Technician CPT (AAH)
ACA Certified Phlebotomy Technician CPT(ACA)
AECA Certified Phlebotomy Technician Specialist CPTS (AECA)
AMCA PTC (AMCA)
AMT Register Phlebotomy Technician RPT(AMT)
ASCP Phlebotomy Technician PBT(ASCP)
ASPT Certified Phlebotomy Technician CPT(ASPT)
IAPA
NCA CLPlb(NCA)
NCCT/MMCI National Certified Phlebotomy Technician NCPT(NCCT)
NHA Certified Phlebotomy Technician CPT(NHA)
NAHP National Registered Certified Phlebotomy Technician NRCPT(NAHP)
NPA Certified Phlebotomy Technician CPT(NPA)
NPCE Phlebotomy Technician
NPS 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

Notes and References

  1. Ernst . Dennis . Phlebotomy certification legislation: update on three of our 50 states. . Medical Laboratory Observer . October 2009 . 41 . 10 . 42 . 19891151 . 17 February 2024. .
  2. Ernst . DJ . States fail to follow California's lead in certifying phlebotomists. . Medical Laboratory Observer . July 2008 . 40 . 7 . 40, 42 . 18717500. .
  3. Kwan . H . Rooster guarding hen house? . Medical Laboratory Observer . October 2008 . 40 . 10 . 6, 8 . 18990788.
  4. News: Mishori . Ranit . Drawing Without a License . 17 February 2024 . . May 31, 2004.
  5. Should non-phlebotomists be allowed to draw blood? . Clinical Leadership & Management Review . November 2001 . 15 . 6 . 426–8 . 11822275.
  6. Becan-McBride . Kathleen . Phlebotomy Errors Point to Need for Mandatory Licensure of Pre-analytical Laboratory Staff . Critical Values . 1 October 2009 . 2 . 4 . 18–19 . 10.1093/criticalvalues/2.4.18 .
  7. Harty-Golder . Barbara . When should a phlebotomist ask for help with a difficult draw? . MLO: Medical Laboratory Observer . January 2003 . 35 . 1 . 48 . 12561745 . .
  8. Book: Flynn . John C. . Procedures in Phlebotomy . 9 August 2013 . Elsevier Health Sciences . 978-0-323-27709-9 . 180 . 19 August 2024 . en . Medical-Legal Issues and Health Law Procedures.
  9. Ernst . DJ . Is the phlebotomist obsolete? . MLO: Medical Laboratory Observer . October 1997 . 29 . 10 . 30–4 . 10173584. .
  10. News: Dharma . RanjithKumar . BD receives clearance for new blood collection device . 30 April 2024 . Medical Device Network . 8 December 2023.
  11. News: Vein attempts? Making needles easier to bear . 30 April 2024 . Orange County Register . 14 September 2007.
  12. Book: McCall . Ruth E. . Tankersley . Cathee M. . Phlebotomy Exam Review . 2008 . Lippincott Williams & Wilkins . 978-0-7817-7855-8 . en.
  13. Book: Strasinger . Susan King . Lorenzo . Marjorie Schaub Di . The Phlebotomy Textbook . 25 February 2019 . F.A. Davis . 978-0-8036-9012-7 . 11–12 . en.
  14. Book: Niedzwiecki . Brigitte . Kinn's Medical Assisting Fundamentals - E-Book: Kinn's Medical Assisting Fundamentals - E-Book . 21 October 2021 . Elsevier Health Sciences . 978-0-323-82454-5 . 1124 . en.
  15. California to require certification for technicians who draw blood. . AIDS Policy & Law . 29 October 1999 . 14 . 20 . 11 . 11367053.
  16. Proposed law would beef up phlebotomy training: Training can't prevent irresponsibility . Hospital Infection Control & Prevention . June 1, 1999 .
  17. Web site: Phlebotomy Technician I (CPT I) Certificate . CDPH LFS . 30 April 2024 . January 29, 2024.
  18. Web site: Phlebotomy Technician II (CPT II) Certificate . CDPH LFS . 30 April 2024 . January 29, 2024.
  19. News: Lab Worker Arrested for Reusing Needles . 17 February 2024 . . 5 March 2000.
  20. News: Reuse of Needles at Clinic Yields 1-Year Term . 17 February 2024 . Los Angeles Times . 17 August 2002.
  21. News: Hawkes . Alison . Final arguments heard in needle re-using nurse's trial . 17 February 2024 . San Mateo Daily Journal . 1 December 2000 . en.
  22. News: Lite . Jordan . Palo Alto Blood-Test Worker Caught Reusing Needles . 17 February 2024 . . 18 April 1999.
  23. News: Writer . Chuck Squatriglia, Chronicle Staff . Phlebotomist Held in Year-Old Needles Case / Palo Alto lab worker had acknowledged reusing medical equipment . SFGATE . en.
  24. Michel . Robert . Palo Alto Needle Reuse Episode Widens in Scope . The Dark Report . 7 June 1999 . VI . 8 .
  25. Michel . Robert . California Assesses Fines After Needle Reuse by SBCL Employee . The Dark Report . 9 August 1999 . VI . 11 .
  26. Risk of infection from needle reuse at a phlebotomy center . American Journal of Public Health . 1 April 2001 . 91 . 4 . 636–638 . 10.2105/ajph.91.4.636. 11291380 . Porco . T. C. . Aragón . T. J. . Fernyak . S. E. . Cody . S. H. . Vugia . D. J. . Katz . M. H. . Bangsberg . D. R. . 1446637 .
  27. Web site: § 3–1209.12. Phlebotomist. D.C. Law Library . code.dccouncil.us . 30 April 2024.
  28. Web site: Act 20-618, Clinical Laboratory Practitioners Amendment Act of 2014 . dcregs.dc.gov . 30 April 2024.
  29. Web site: Department of Public Health Frequently Asked Questions . dph.illinois.gov . 17 February 2024 . en . 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. Web site: Public Act 101-0542 . . 17 February 2024 . Dec 1, 2020.
  31. News: Wall . Craig . New laws 2020: Illinois laws, fees that take effect January 1 . 17 February 2024 . ABC7 Chicago . December 19, 2019 . en.
  32. Web site: New Training Requirements Enacted for Phlebotomists . . 17 February 2024 . October 10, 2019.
  33. Web site: Illinois General Assembly – Bill Status of HB5011 99th General Assembly . www.ilga.gov.
  34. Web site: An Act Establishing a Board of Registration of Phlebotomists. Bill H.312 . malegislature.gov . 30 April 2024.
  35. Web site: NC DHSR AHCLCS CLIA: Frequently Asked Questions . North Carolina Division of Health Service Regulation . 30 April 2024 . April 25, 2019 . 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..