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Stuck on Phlebotomy ???
Phlebotomy
Regulations:
They’re Here!
В© BCJ
!CAVEAT!
Contents of these slides are
subject to change.
2/04/03
GOVERNMENT 101
What are Regulations?
Three Branches of
Government
Legislative
Executive
Will of the people
Administration
Statutes
Regulations
Judicial
Judgment
Disputes
Laboratory Field Services (LFS)
is a branch of the Department of Public
Health (CDPH), which is part of the
Executive Branch, whose duty is to
execute a new law.
STATUTES
are born out of legislation, reflecting the
will of the people
LEGISLATION = WILL OF
THE PEOPLE
• Public concern leads to intent to change the
law
• Legislator sponsors a “bill” in the California
senate or house
• Bill is subjected to review and vote in both
houses
• Governor may sign, not sign, or veto
• If signed, bill is incorporated into statute.
Most lab statutes are contained in BPC
• Example - AB 1557, Migden Bill
Regulations
develop and grow through administrative
efforts within the Executive Branch
REGULATIONS =
ADMINISTRATION
• Department concern leads to intent to change
the law
• Department develops regulations (legal
language to add to current law) - regulations
carry out the intent of a statute
• Regulations are subject to public review and
comment, either before or after effective date
• Regulations must be approved by the OAL,
signed by the Sect’y of State
• Example - CCR Title 17, Section 1034
History of the Regulations
CCR Title 17, Section 1034
Requirements
•
•
•
•
•
Current Law 1973
Must work for licensed lab
Specific authorization of MD
Ten hours training by MD or CLB
Three venipunctures and three skin
punctures
• Certificate signed by MD or CLB
History of the Regulations
BPC 1246(a)
Requirements
• Statute applies to currently employed
phlebotomists
• Must meet training regulations
• Supervised by MD, RN, Chapter 3
• “Five Minute Rule”
History of the Regulations
Efforts to Change 1973 Requirements
•
•
•
•
Complaints about “weekend” programs
Complaints about un-employability
Complaints by patients
Advisory committee urging
History of the Regulations
•CLTAC , Clinical Laboratory Technology Advisory
Committee – prominent members, respected opinions,
research of issues/areas of concern, valuable findings,
highly regarded by CDPH
•CLTAC findings – nat’l standards = 40 – 120 hrs of
training, nat’l certif is voluntary, most labs expand training
reqmts, many labs require nat’l certif, 1997 position paper
to CDPH
History of the Regulations
REGS STORED AWAY
KEEP OUT!
History of the Regulations
Call to Action
Phlebotomy scare in Feb. 1999:
• Palo Alto phlebotomist confessed to
reusing needles
• Widespread re-testing of patients
• High visibility press coverage
• Great public concern
• Criticism of CDPH for poor standards
MIGDEN PHLEBOTOMY
LEGISLATION (AB 1557)
•
•
•
•
•
•
•
•
•
Used many of CLTAC recommendations
Revised the BPC 1246 & HSC 120580
Mandates CDPH to set standards
Authorizes Department to write regulations
Increases education, training
Requires examination, certification
Requires CE
Less training for OTJE phlebs
Three year phase-in to obtain certificate after
regulations are adopted
• Authorizes CDPH to charge fees
Overview of New Regulations
R-16-99
3 Key elements
1. 3 Year phase-in (to obtain certificate) for “on-thejob-experience” = grandfathering clause
2. Less required phlebotomy training program
coursework, if greater than 1040 hours OTJE at
the time of application for CA State certification
3. CE: 6 hours/2 years (3 hours/year) for a 2 year
certificate
Key Element #1
OTJE =“Grandfathering” 3 Year
Phase-In To Obtain Certificate
• On-The-Job-Experience (OTJE)
- Paid or volunteer
- 1 Hour or more
• Has 3 years from the date that the
regulations take effect to obtain a Limited PT,
CPT I or CPT II from CDPH-LFS
Key Element # 2
OTJE = Fewer Hours of Didactic
Coursework
• > 1040 hours of OTJE - requires 20 hours of advanced
didactic instruction from a CDPH-LFS approved
phlebotomy training program
• < 1040 hours of OTJE - requires 40 hours of basic and
advanced didactic instruction from a CDPH-LFS
approved phlebotomy training program
- This is the same requirement for didactic instruction
as a new phlebotomy student
Key Element # 3:
3 CE Hours / Year
• Must obtain at least 3 hours /year
• Must show proof of CE with renewal application
- Biannual renewal - 2 years
- 2 years = 6 hours with renewal application
• Existing CE providers will be those CDPH approved
Clinical Lab Scientists (CLS) CE providers
• New CE providers must be approved under the standards
for CLS CE providers
Overview of New Regulations
R-16-99
New language contains many more requirements for
education, training, experience, examination and
certification.
3 New categories of standards & definitions
* 3 levels of certification for phlebotomy
technicians
•
Requirements for phlebotomy training programs & approval
process by CDPH-LFS
•
Requirements for certifying organizations to give exams &
approval process by CDPH-LFS
NEW CATEGORY OF LAB
PERSONNEL
• Phlebotomist
Defined as a person who collects blood for
clinical laboratory test or examination
purposes
LEVELS OF CERTIFICATION
“Limited
PT” - skin puncture only
“CPT 1” - skin plus venipuncture
“CPT 2” - skin plus veni plus arterials
All levels: Education must be HS or
equivalent
LIMITED PHLEBOTOMY TECHNICIAN
•Restricted to skin punctures
•HS or equivalent
•20 hours basic didactic
•25 skin punctures in a clinical setting
•Training certified by MD, CLB, CLS, PA or RN
•No examination
•State certification plus CE
CERTIFIED PHLEBO TECH I
No experience
•HS or equivalent
•40 hours didactic - basic & advanced
•40 hours practical in clinical setting
•50 venipunctures + 10 skin punctures
•Examination by approved certifying organization
•State certification and CE
CERTIFIED PHLEBO TECH I
<1040 hours of OTJE
at time of application to LFS
•HS or equivalent
•40 hours didactic - basic & advanced
•Documentation of OTJE experience within previous
five years including “50 + 10”
•Examination by approved certifying organization
•State certification and CE
CERTIFIED PHLEBO TECH 1
1040 or more hours of OTJE
at time of application to LFS
•HS or equivalent
•20 hours advanced didactic
•Documentation of OTJE within previous five years
including “50 + 10”
•Examination by approved certifying organization
•State certification plus CE
CERTIFIED PHLEBO TECH 2
•Skin + venipunctures + arterials
•HS graduation or GED
•CPT I or meets requirements of CPT I
•Documentation of training - 1040 hours of OTJE in
phlebotomy within previous five years
•Minimum of 20 supervised arterials by MD, PA, RN,
RCP, CLS
•State certification and CE
SCOPE OF PRACTICE
Common Elements
• Maintain a current, valid certification with CDPH
• Employed by a clinical lab or public health dept
• Perform punctures under supervision - licensed MD, PA,
CLB, RN, CLS, or their designee licensed or certified
under Chapter 3
• Subject to monthly review by supervisor
• Demonstrate competency after employment - yearly
SCOPE OF PRACTICE
Common Elements
• Post current state certificate at work location
• Carry ID card when away from posted location
• No direct and constant supervision required; remote
supervision allowed
• Supervisor shall be accessible by on-site, telephone
or electronic communication
• CPT II must perform arterials only when lic’d persons
present
• Complete 3 hours/year or 6 hours/2 years of CE
Overview of New Regulations
R-16-99
New language contains many more requirements for
education, training, experience, examination and
certification.
3 New categories of standards & definitions
1. 3 levels of certification for phlebotomy technicians
2. *Requirements for phlebotomy training programs
& approval process by CDPH-LFS
3. Requirements for certifying organizations to give exams &
approval process by CDPH-LFS
PHLEBOTOMY TRAINING
PROGRAMS
WHO?
WHAT?
WHERE?
WHERE?
•California licensed clinical laboratory
•US military medical lab specialist program
•Accredited US College/University
•Adult Education and ROP
•Private, post-secondary or occupational
program registered or approved by BPPVE
•National Accrediting Agency for Clinical
Laboratory Sciences (NAACLS)
WHO?
• Director = MD, CLB, CLS, PA or RN
• Instructor = MD, CLB, CLS, PA, RN, RCP with 2 out
of previous 5 yrs OTJE, or Current Instructor
(Phlebotomist) with 3 out of 5 yrs experience who will
be allowed to teach until December 31, 2003 and
must obtain CPT certificate from CDPH-LFS by that
same date.
NEWS FLASH!
ALL didactic instructors must
successfully pass a phlebotomy exam
administered by an approved certifying
organization.
WHAT?
•Didactic (Classroom) Instruction
•Minimum 20 hours “Basic”
•Minimum 20 hours “Advanced”
•Total 40 hours
•Practical (hands on ) Instruction
•Clinical setting with real patients
•Training: from test requisition to disposal of sharps
•Minimum 40 hours
•Assures students complete 50 venipunctures and
10 skin punctures during or after the practical
instruction
DIDACTIC TRAINING --20 HOURS “BASIC”
• Infection control and safety, universal
precautions
• Circulatory system, Basic anatomy &
physiology
• Medical terminology
• Patient & specimen identification
• Selecting & preparing skin puncture site &
antiseptic
• Blood collection equipment, proper order of
the tubes, anticoagulant
• Post Puncture Care
• Medical waste and sharps
DIDACTIC TRAINING --20 HOURS “ADVANCED”
• Advanced infection control & biohazards
• Pre-analytical sources of error in specimen collection
• Anatomical site selection & patient preparation
• Risk factors & complications
• Anticoagulation Theory
• Corrective actions to take with phlebo & specimen
processing
• Problem solving
• Communications, stress, behavior, ethics
• QA in phlebotomy practice
PRACTICAL TRAINING --40 HOURS
• Clinical Setting
• Access to real patients
• Equipment
• Patient preparation / Infection Control
• Blood collection from various ages, health & weight
•Post puncture care
• Blood processing after collection, centrifugation
• Disposal of waste & sharps
•Practical Exam
•No arterials drawn, just observe
PROGRAM MUST PROVIDE
CERTIFICATE OF COMPLETION
• Given upon satisfactory completion of training
• Certificate must include:
- Name and address of training program
Phleb
Supreme
- Name of trainee
- Statement of satisfactory completion of program
- Beginning and End dates of the training
• Program must maintain a copy of the certificate for 5 years
LFS MUST APPROVE PHLEBOTOMY
TRAINING PROGRAM
• Submit application:
- Routine vital information
- Location of sites
- Program director: MD, PA, RN, CLB, CLS
- Instructors: MD, PA, RN, CLB, CLS, RCP, CPT
- List of equipment, supplies, and educational
materials
- Curriculum with instructional objectives and hours
spent at each activity, schedule of classes.
- No Fee
LFS MUST APPROVE PHLEBOTOMY
TRAINING PROGRAM
• Application Timeframes
- Initial Approval Process
- Within 60 days, CDPH shall notify program
regarding application:
- Complete & approved
- Incomplete & cannot process; must
submit documentation within 30 days
- Reviewed but does not meet
requirements & is denied
- Application considered Abandoned if
failure to respond to CDPH within 30
days after request for further
documents
-LFS intends to expedite the approval process
LFS MUST APPROVE PHLEBOTOMY
TRAINING PROGRAMS
• Timeframes for Approval:
- Processing ranges from 30 - 150 days
- Average is 90 days
• Approval given for 2 years
• CDPH may conduct On-Site Inspection to verify compliance
• Renewal Application
- Must submit at least 60 days before expiration
• Timeframes for Renewal:
- Processing ranges from 15 - 60 days
- Average is 30 days
Overview of New Regulations
R-16-99
New language contains many more requirements for
education, training, experience, examination and
certification.
3 New categories of standards & definitions
1. 3 levels of certification for phlebotomy technicians
2. Requirements for phlebotomy training programs & approval
process by CDPH-LFS
3. *Requirements for certifying organizations to give
exam & approval process by CDPH-LFS
BPC 1246(b) CERTIFYING EXAMINATION
• National certification examinations
• Exams given by Certifying organizations
• Organizations must be approved by CDPH-LFS
on and after the effective date of the
regulations, that is April 9, 2003.
CERTIFYING ORGANIZATIONS
• Nationally recognized
• Independent, Not-for-profit
• Currently 10 organizations MAY qualify for LFS
approval
• Will issue certificate to phlebotomists and notify
CDPH-LFS
CERTIFYING ORGANIZATION
EXAMINATION
•
•
•
•
•
Evaluates relevant standards of phlebotomy
Test skills and knowledge to assure competence
Developed by subject matter experts
Reviewed annually for relevance
Valid and reliable according to established test taking
standards (psychometric evaluation)
• Ensure security during exam
• Make all examinee records available to CDPH-LFS
• Maintain records for minimum of 5 years
Overview of New Regulations
R-16-99
3 Steps to achieve State certification
•
Attend an approved phlebotomy training program to complete
coursework
•
Take an exam from an approved certifying organization
•
Apply to LFS to obtain a certificate as a “Limited Phlebotomy
Technician” or a “Certified Phlebotomy Technician”
-- applicant to submit $54 & 2 photos for first 2 year certificate
ID CARD
Phleb
Supreme
Certified
Phleb
Supreme
STEP # 1
COMPLETE INSTRUCTION AT AN APPROVED
PHLEBOTOMY TRAINING PROGRAM
• Any “On-the-job-experience ? OTJE = “Grandfathering Clause”
to allow 3 year Phase-In
• Number of hours of OTJE determines hours of coursework
required; < 1040 hrs = must take 40 hrs of basic and advanced
didactic training, > 1040 hrs = 20 hrs of advanced didactic
training, hours based on # accrued at time of application to LFS
• Decide which level of certification to obtain
• Obtain certificate after successful completion of courses
• Submit copy of certificate with CPT application to LFS
STEP # 2
PASS PHLEBOTOMY CERTIFICATION EXAM
OFFERED BY AN APPROVED CERTIFYING
ORGANIZATION
• Must take and pass the CPT examination from only an approved
certifying organization
• No “Limited PT” examination required
• Obtain certificate after passing the examination
• Submit copy of certificate with CPT application to LFS
STEP # 3
LFS ISSUES LIMITED & CPT CERTIFICATES
• Submit $54, 2 passport size photos and completed
application with documentation of:
- HS education or equivalent
- Phlebotomy training program certificate
- Certifying organization certificate
• State will issue certificate and wallet size ID card
within 90 days
• Renewal biannually (2 years) with proof of 6 CE
hours (3 hours x 2 yrs)
WHAT’S OUR GOAL?
BENEFITS FOR PHLEBOTOMISTS
Immediate
• If working, 3 years to be certified
• Improved public acceptance
After State Certification
• No more “5 minute rule”
• Can work at remote locations
• Foundation for advancement
• First step in clinical lab career
ladder:
CPT - MLT - CLS Supervisor - Director
• Enhanced employability
HURDLES TO CLEAR
•Must be employed by a clinical lab or Public Health
Dept.
•Shown competent by supervisor before drawing
patients
•CE: 3 hours annually or 6 hours biannually
•Carry current valid ID card when off site
•Pay certification fee
!CAVEAT!
Contents of these slides are
subject to change.
2/04/03
PHLEBOTOMY
ISSUES OF INTEREST
90 Day Filing Order
January 9 - April 9, 2003
• 90 day “Delay” period for LFS to receive and review
applications from:
- training schools
- certifying organizations
• Old regulations will continue to apply.
• Phlebotomy classes in progress:
- Must apply for approval in 90 day window
- Completion before April 9, 2003: old regs OK
- Completion on & after April 9, 2003 : must teach
new requirements AND be LFS approved.
90 Day Filing Order – cont.
January 9 - April 9, 2003
• April 9, 2003
New Regulations become effective and enforceable
- Schools are “approved” on that date
- Students from approved school will be first
graduating class under new laws
- CDPH approved certifying organizations can offer
certification exam
Public Health STD Phlebotomists
HSC 120580
• PH statute amended – requires that public health
phlebotomists working in sexually transmitted disease
(STD) clinics obtain state certification
• Applies to all PH Dept workers who perform
phlebotomy – mostly STD clinics
• Migden bill supersedes older PH laws that allow PH
MD’s to train own phlebotomists without any CDPH
certification
• PH facilities wishing to train own staff will need to
meet training program requirements
Public Health STD
Phlebotomists
•
PH and Local County Health Officers reluctant to
recognize authority of upcoming regulations, but
Department has ruled that Migden bill is the law.
•
PH Phlebs – please do not panic – remember the
3 yr “grandfathering” clause
WHO CAN PERFORM
PHLEBOTOMY UNDER
CALIFORNIA LAW?
Persons authorized by their
scopes of practice, such as
MD, CLB, CLS, PA, RN, LVN,
MA, and several others
(not CNA or PCP)
Some restrictions apply
See the Handout for the
complete list.
Medical Assistants & EMTs
• MAs: must have passed phlebo training as a MA
• MA Scope: non-acute, clinic, MD office – MD must
be present unless free health clinic (PA, NP)
• EMT 1- no phleb allowed, EMT 2 & Paramedic - OK
• EMT 2 & paramedic: pre-hospital, emergency
venue only
• If working in clinical lab or hospital as phlebotomist:
then working outside scope - must obtain separate
phlebotomy certification
Foreign or Out-of-State
Phlebotomists
•
Foreign – must submit HS/College transcripts
translated into English from “Translation Service”
approved for legal or governmental translation,
Example: See website: www. phlebotomywest.com
•
Out-Of-State
- Experience will “count”
- Training program must be approved by LFS to satisfy
20 or 40 hr didactic requirement (i.e. NAACLS)
- Certifying exam will satisfy exam requirement if
taken after certifying organization approved by
LFS
EMPLOYED BY??
• Must be clinical labs (BPC 1246)
• Broad definition of employer
- Wages / pay stub need not originate from lab
- Requires lab director oversight & responsibility
for phlebotomists’ training and competency
(BPC 1209)
- OK to work beyond confines of lab
Example: Phlebs working in ERs, special clinics
within hospital, draw stations
Non-Clinical Lab Employers
• Non-clinical labs:
- OSHA monitoring services (Occupational Health)
- Forensics labs, law enforcement contracting
services
- Insurance company contractors
Recent Milestones
• November 23, 2001
– R-16-99 published in the California
Regulatory Notice Register
• November 21, 2002
– CDPH Director’s approval granted
• January 9, 2003
– R-16-99 filed with the
Secretary of State
• April 9, 2003
– Implementation &
Enforcement of new regs
Public Comment &
Department Response
R-16-99
0 4 -A
1 0 3 1 .4 (c )(9 ) / E x e m p t p h le b o to m is ts w h o
C e rtific a tio n h a v e c u rre n t c e rtific a tio n
Exam
th ro u g h a c e rtify in g
o rg a n iz a tio n th a t c u rre n tly
m e e ts th e re q u ire m e n ts o f
p ro p o s e d S e c tio n 1 0 3 1 .7 .
D E C L IN E D . A B 1 5 5 7
SO R, page 7,
am ended BPC
a d d c la rific a tio n .
1 2 4 6 (b )(1 ) to re a d : "O N
a n d A F T E R th e e ffe c tiv e
d a te o f th e re g u la tio n s
s p e c ifie d in p a ra g ra p h
(2 )..." P a ra g ra p h (2 )(A )
re q u ire s a c u rre n t
c e rtific a tio n iss u e d b y a n
agency A PPR O VED by
th e D e p a rtm e n t.
P h le b o to m is ts w h o
a tta in e d c e rtific a tio n p rio r
to th e e ffe c tiv e d a te o f
th e re g u la tio n s d o n o t
m e e t th is re q u ire m e n t. T o
e x e m p t th e m w o u ld
re q u ire le g is la tiv e a c tio n .
Handouts
•
•
•
•
•
CA Phlebotomy Regulations History & Overview
CA Phlebotomy Regulations Timeline
How to Obtain a Phlebotomy Certificate
FAQs - Frequently Asked Questions & Answers
Phlebotomy Training Program Approval Application
AND “Instructions” sheet
• Certifying Organizations
• Important Internet Addresses
• Persons Authorized to Withdraw Blood
ANY BURNING
QUESTIONS???
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