Stuck on Phlebotomy ???

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Phlebotomy Regulations:

They’re Here!

!CAVEAT!

Contents of these slides are subject to change.

2/04/03

GOVERNMENT 101

What are Regulations?

Three Branches ofGovernment

Judicial

Judgment

DisputesDisputes

Legislative

Will of the people

StatutesStatutes

Executive

Administration

RegulationsRegulations

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 RegulationsCCR 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 RegulationsBPC 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 RegulationsREGS STORED AWAY

KEEP OUT!

History of the RegulationsCall 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 PHLEBOTOMYLEGISLATION (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

3 Key elements

1. 3 Year phase-in (to obtain certificate) for “on-the- job-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

Overview of New RegulationsR-16-99

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

* 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 language contains many more requirements for education, training, experience, examination and certification.

3 New categories of standards & definitions

NEW CATEGORY OF LAB PERSONNEL

• PhlebotomistDefined 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 OTJEat 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 PRACTICECommon 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 PRACTICECommon 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

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

New language contains many more requirements for education, training, experience, examination and certification.

3 New categories of standards & definitions

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

- 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

Phleb

Supreme

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

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

New language contains many more requirements for education, training, experience, examination and certification.

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 RegulationsR-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

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 # 1

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 # 2

• 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)

LFS ISSUES LIMITED & CPT CERTIFICATES

STEP # 3

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 OrderJanuary 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 PhlebotomistsHSC 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

04-A 1031.4(c)(9) /CertificationExam

Exempt phlebotomists whohave current certificationthrough a certifyingorganization that currentlymeets the requirements ofproposed Section 1031.7.

DECLINED. AB 1557amended BPC1246(b)(1) to read: "ON and AFTER the effective date of the regulationsspecified in paragraph(2)..." Paragraph (2)(A)requires a currentcertification issued by anagency APPROVED by the Department.Phlebotomists whoattained certification priorto the effective date ofthe regulations do notmeet this requirement. Toexempt them wouldrequire legislative action.

SOR, page 7,add clarification.

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???