Phlebotomy licensure in the United States

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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.{{cite journal |last1=Ernst |first1=Dennis |title=Phlebotomy certification legislation: update on three of our 50 states. |journal=Medical Laboratory Observer |date=October 2009 |volume=41 |issue=10 |pages=42 |pmid=19891151 |url=https://www.mlo-online.com/home/article/13003418/phlebotomy-certification-legislation-update-on-three-of-our-50 |access-date=17 February 2024|id={{Gale|A210847808}} }}{{cite journal |last1=Ernst |first1=DJ |title=States fail to follow California's lead in certifying phlebotomists. |journal=Medical Laboratory Observer |date=July 2008 |volume=40 |issue=7 |pages=40, 42 |pmid=18717500|id={{Gale|A182040780}} }}{{cite journal |last1=Kwan |first1=H |title=Rooster guarding hen house? |journal=Medical Laboratory Observer |date=October 2008 |volume=40 |issue=10 |pages=6, 8 |pmid=18990788}}

Phlebotomy licensure advocates claim that the licensure would enhance the quality of personnel, while the laboratory industry opposes phlebotomy licensure as an unnecessary cost.{{cite news |last1=Mishori |first1=Ranit |title=Drawing Without a License |url=https://www.washingtonpost.com/archive/lifestyle/wellness/2004/06/01/drawing-without-a-license/6171f338-24d6-49d1-b4e3-989cf6f3e5b4/ |access-date=17 February 2024 |newspaper=Washington Post |date=May 31, 2004}}{{cite journal |title=Should non-phlebotomists be allowed to draw blood? |journal=Clinical Leadership & Management Review |date=November 2001 |volume=15 |issue=6 |pages=426–8 |pmid=11822275}}{{cite journal |last1=Becan-McBride |first1=Kathleen |title=Phlebotomy Errors Point to Need for Mandatory Licensure of Pre-analytical Laboratory Staff |journal=Critical Values |date=1 October 2009 |volume=2 |issue=4 |pages=18–19 |doi=10.1093/criticalvalues/2.4.18 |url=https://academic.oup.com/criticalvalues/article/2/4/18/2949721|url-access=subscription }} Phlebotomy is not without risk, and more challenging patients increase the chance of complications.{{cite journal |last1=Harty-Golder |first1=Barbara |title=When should a phlebotomist ask for help with a difficult draw? |journal=MLO: Medical Laboratory Observer |date=January 2003 |volume=35 |issue=1 |pages=48 |pmid=12561745 |id={{Gale|A96892952}} }} 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.{{cite book |last1=Flynn |first1=John C. |title=Procedures in Phlebotomy |date=9 August 2013 |publisher=Elsevier Health Sciences |isbn=978-0-323-27709-9 |page=180 |chapter-url=https://books.google.com/books?id=PexOAQAAQBAJ&pg=PA181 |access-date=19 August 2024 |language=en |chapter=Medical-Legal Issues and Health Law Procedures}}

Increasingly, a number of healthcare facilities are rolling phlebotomy duties into their patient care technician roles or other allied health roles.{{cite journal |last1=Ernst |first1=DJ |title=Is the phlebotomist obsolete? |journal=MLO: Medical Laboratory Observer |date=October 1997 |volume=29 |issue=10 |pages=30–4 |pmid=10173584| id={{Gale|A20076530}} }}

A number of FDA 510k cleared devices, such as the BD Minidraw have been introduced to enable the drawing of blood without a phlebotomist.{{cite news |last1=Dharma |first1=RanjithKumar |title=BD receives clearance for new blood collection device |url=https://www.medicaldevice-network.com/news/bd-clearance-blood-collection-device/ |access-date=30 April 2024 |work=Medical Device Network |date=8 December 2023}} Additionally, there are devices to help aid non-phlebotomists more readily find veins.{{cite news |title=Vein attempts? Making needles easier to bear |url=https://www.ocregister.com/2007/09/14/vein-attempts-making-needles-easier-to-bear/ |access-date=30 April 2024 |work=Orange County Register |date=14 September 2007}}

Certifications

There are several national phlebotomy certifications in the US.{{cite book |last1=McCall |first1=Ruth E. |last2=Tankersley |first2=Cathee M. |title=Phlebotomy Exam Review |date=2008 |publisher=Lippincott Williams & Wilkins |isbn=978-0-7817-7855-8 |url=https://books.google.com/books?id=Ly5NPgAACAAJ |language=en}}{{cite book |last1=Strasinger |first1=Susan King |last2=Lorenzo |first2=Marjorie Schaub Di |title=The Phlebotomy Textbook |date=25 February 2019 |publisher=F.A. Davis |isbn=978-0-8036-9012-7 |pages=11–12 |url=https://books.google.com/books?id=eJWNDwAAQBAJ |language=en}}{{cite book |last1=Niedzwiecki |first1=Brigitte |title=Kinn's Medical Assisting Fundamentals - E-Book: Kinn's Medical Assisting Fundamentals - E-Book |date=21 October 2021 |publisher=Elsevier Health Sciences |isbn=978-0-323-82454-5 |page=1124 |url=https://books.google.com/books?id=Mo9JEAAAQBAJ&pg=PA1124 |language=en}}{{cite book |last1=McCall |first1=Ruth E. |last2=Tankersley |first2=Cathee M. |title=Phlebotomy Exam Review |date=2004 |publisher=XYZ editeur/XYZ Publishing |isbn=978-0-7817-3354-0 |pages=xii-xiii |url=https://www.google.com/books/edition/Phlebotomy_Exam_Review/0fljivY9aeEC?hl=en |language=en}}

class="wikitable sortable"

|+ List of Phlebotomy Certifications in the United States

! Abbr !! Phlebotomy Certifying Agency !! Certification !! Designation !! Notes

AAHAmerican Allied HealthCertified Phlebotomy TechnicianCPT (AAH)
ACAAmerican Certification Agency for Healthcare ProfessionalsCertified Phlebotomy TechnicianCPT(ACA)
AECAAmerican Education Certification AssociationCertified Phlebotomy Technician SpecialistCPTS (AECA)
AMCAAmerican Medical Certification AssociationPTC (AMCA)
AMTAmerican Medical TechnologistsRegister Phlebotomy TechnicianRPT(AMT)
ASCPAmerican Society for Clinical PathologyPhlebotomy TechnicianPBT(ASCP)
ASPTAmerican Society of Phlebotomy TechniciansCertified Phlebotomy TechnicianCPT(ASPT)
IAPAInternational Academy of Phlebotomy Sciences
NCANational Credentialing Agency for Laboratory PersonnelCLPlb(NCA)
NCCT/MMCINational Center for Competency TestingNational Certified Phlebotomy TechnicianNCPT(NCCT)
NHANational Healthcareer AssociationCertified Phlebotomy TechnicianCPT(NHA)
NAHPNational Association for Health ProfessionalsNational Registered Certified Phlebotomy TechnicianNRCPT(NAHP)
NPANational Phlebotomy AssociationCertified Phlebotomy TechnicianCPT(NPA)
NPCENational Phlebotomy Certification ExaminationPhlebotomy Technician
NPSNational Performance SpecialistCertified 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.{{cite journal |title=California to require certification for technicians who draw blood. |journal=AIDS Policy & Law |date=29 October 1999 |volume=14 |issue=20 |pages=11 |pmid=11367053}}{{cite journal |title=Proposed law would beef up phlebotomy training: Training can't prevent irresponsibility |journal=Hospital Infection Control & Prevention |date=June 1, 1999 |url=https://www.reliasmedia.com/articles/41839-proposed-law-would-beef-up-phlebotomy-training}}

California has two levels of phlebotomy licensure:

  • Certified Phlebotomy Technician I (CPT I) – authorized to perform skin puncture and venipuncture blood collection.{{cite web |title=Phlebotomy Technician I (CPT I) Certificate |url=https://www.cdph.ca.gov/Programs/OSPHLD/LFS/Pages/Phlebotomist-CPTI.aspx |publisher=CDPH LFS |access-date=30 April 2024 |date=January 29, 2024}}
  • Certified Phlebotomy Technician II (CPT II) – authorized to perform skin puncture, venipuncture, and arterial puncture blood collection.{{cite web |title=Phlebotomy Technician II (CPT II) Certificate |url=https://www.cdph.ca.gov/Programs/OSPHLD/LFS/Pages/Phlebotomist-CPTII.aspx |publisher=CDPH LFS |access-date=30 April 2024 |date=January 29, 2024}}{{source-attribution}}

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.{{cite news |title=Lab Worker Arrested for Reusing Needles |url=https://www.latimes.com/archives/la-xpm-2000-mar-05-me-5530-story.html |access-date=17 February 2024 |work=Los Angeles Times |date=5 March 2000}}{{cite news |title=Reuse of Needles at Clinic Yields 1-Year Term |url=https://www.latimes.com/archives/la-xpm-2002-aug-17-me-sbriefs17.1-story.html |access-date=17 February 2024 |work=Los Angeles Times |date=17 August 2002}}{{cite news |last1=Hawkes |first1=Alison |title=Final arguments heard in needle re-using nurse's trial |url=https://www.smdailyjournal.com/news/local/final-arguments-heard-in-needle-re-using-nurses-trial/article_a8e35141-018c-5038-8fd4-22402d8c9c20.html |access-date=17 February 2024 |work=San Mateo Daily Journal |date=1 December 2000 |language=en}} The laboratory conducted an internal review of its phlebotomy practices at its 800 sites across the United States and found no deficiencies.{{cite news |last1=Lite |first1=Jordan |title=Palo Alto Blood-Test Worker Caught Reusing Needles |url=https://www.latimes.com/archives/la-xpm-1999-apr-18-mn-28540-story.html |access-date=17 February 2024 |work=Los Angeles Times |date=18 April 1999}} 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.{{cite news |last1=Writer |first1=Chuck Squatriglia, Chronicle Staff |title=Phlebotomist Held in Year-Old Needles Case / Palo Alto lab worker had acknowledged reusing medical equipment |url=https://www.sfgate.com/health/article/phlebotomist-held-in-year-old-needles-case-palo-2799480.php |work=SFGATE |language=en}}{{cite journal |last1=Michel |first1=Robert |title=Palo Alto Needle Reuse Episode Widens in Scope |journal=The Dark Report |date=7 June 1999 |volume=VI |issue=8 |url=https://www.darkintelligencegroup.com/the-dark-report/laboratory-compliance/palo-alto-needle-reuse-episode-widens-in-scope/}}{{cite journal |last1=Michel |first1=Robert |title=California Assesses Fines After Needle Reuse by SBCL Employee |journal=The Dark Report |date=9 August 1999 |volume=VI |issue=11 |url=https://www.darkintelligencegroup.com/the-dark-report/laboratory-compliance/california-assesses-fines-after-needle-reuse-by-sbcl-employee/}} A subsequent study found a low risk of infection from the re-used needles due to the low infection prevalence in Palo Alto.{{cite journal |title=Risk of infection from needle reuse at a phlebotomy center |journal=American Journal of Public Health |date=1 April 2001 |volume=91 |issue=4 |pages=636–638 |doi=10.2105/ajph.91.4.636|pmid=11291380 |last1=Porco |first1=T. C. |last2=Aragón |first2=T. J. |last3=Fernyak |first3=S. E. |last4=Cody |first4=S. H. |last5=Vugia |first5=D. J. |last6=Katz |first6=M. H. |last7=Bangsberg |first7=D. R. |pmc=1446637 }}

= Connecticut =

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

= District of Columbia =

In 2014, DC passed Law 20-272, Clinical Laboratory Practitioners Amendment Act of 2014 which established a registration board for phlebotomists.{{cite web |title=§ 3–1209.12. Phlebotomist. {{!}} D.C. Law Library |url=https://code.dccouncil.gov/us/dc/council/code/sections/3-1209.12 |website=code.dccouncil.us |access-date=30 April 2024}}{{cite web |title=Act 20-618, Clinical Laboratory Practitioners Amendment Act of 2014 |url=https://dcregs.dc.gov/Common/NoticeDetail.aspx?NoticeId=N0051881 |website=dcregs.dc.gov |access-date=30 April 2024}}

= 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.{{cite web |title=Department of Public Health Frequently Asked Questions |url=https://dph.illinois.gov/topics-services/health-care-regulation/clia/faqs.html#faq-isaphlebotomistrequiredtohaveacliacertificateandlicenseinillinois-faq |website=dph.illinois.gov |access-date=17 February 2024 |language=en |quote=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.}}

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.{{cite web |title=Public Act 101-0542 |url=https://www.ilga.gov/legislation/publicacts/fulltext.asp?Name=101-0542 |publisher=Illinois General Assembly |access-date=17 February 2024 |date=Dec 1, 2020}}{{cite news |last1=Wall |first1=Craig |title=New laws 2020: Illinois laws, fees that take effect January 1 |url=https://abc7chicago.com/new-illinois-laws-2020/5769462/ |access-date=17 February 2024 |work=ABC7 Chicago |date=December 19, 2019 |language=en}}{{cite web |title=New Training Requirements Enacted for Phlebotomists |url=https://www.team-iha.org/quality-and-safety/physicians-and-advanced-practice-providers/new-training-requirements-enacted-for-phlebotomist |publisher=Illinois Health and Hospital Association |access-date=17 February 2024 |date=October 10, 2019}}

There have been bills to introduce phlebotomy licensure in Illinois, but have been unsuccessful.{{cite web |title=Illinois General Assembly – Bill Status of HB5011 99th General Assembly |url=https://www.ilga.gov/legislation/BillStatus.asp?DocNum=5011&GAID=13&DocTypeID=HB&LegID=94370&SessionID=88#actions |website=www.ilga.gov}}

= 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.

== Louisiana ==

= Massachusetts =

In 2007, a bill (HR 312) was introduced to establish a board of registration of phlebotomists, but did not pass.{{cite web |title=An Act Establishing a Board of Registration of Phlebotomists. Bill H.312 |url=https://malegislature.gov/Bills/186/H312 |website=malegislature.gov |access-date=30 April 2024}}

= Missouri =

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

== Nevada ==

=North Carolina=

North Carolina does not have any additional state requirements for phlebotomy.{{cite web |title=NC DHSR AHCLCS CLIA: Frequently Asked Questions |url=https://info.ncdhhs.gov/dhsr/ahc/clia/cliafaq.html |publisher=North Carolina Division of Health Service Regulation |access-date=30 April 2024 |date=April 25, 2019 |quote=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.}}

== Washington ==

=West Virginia =

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

Further reading

  • {{cite journal |last1=Edwards |first1=Mac |title=Coalition strives for phlebotomy personnel standards |journal=Medical Laboratory Observer |date=Oct 2005 |volume=37 |issue=10 |pages=24–5, 28 |pmid=16295181|id={{Gale|A138320595}} }}

References