Stuck on Phlebotomy ??? Phlebotomy Regulations: TheyвЂ™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 вЂў Public concern leads to intent to change the law вЂў Legislator sponsors a вЂњbillвЂќ in the California senate or house вЂў Bill is subjected to review and vote in both houses вЂў Governor may sign, not sign, or veto вЂў If signed, bill is incorporated into statute. Most lab statutes are contained in BPC вЂў Example - AB 1557, Migden Bill Regulations develop and grow through administrative efforts within the Executive Branch REGULATIONS = ADMINISTRATION вЂў Department concern leads to intent to change the law вЂў Department develops regulations (legal language to add to current law) - regulations carry out the intent of a statute вЂў Regulations are subject to public review and comment, either before or after effective date вЂў Regulations must be approved by the OAL, signed by the SectвЂ™y of State вЂў Example - CCR Title 17, Section 1034 History of the Regulations CCR Title 17, Section 1034 Requirements вЂў вЂў вЂў вЂў вЂў 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 вЂў Certificate signed by MD or CLB History of the Regulations BPC 1246(a) Requirements вЂў Statute applies to currently employed phlebotomists вЂў Must meet training regulations вЂў Supervised by MD, RN, Chapter 3 вЂў вЂњFive Minute RuleвЂќ History of the Regulations Efforts to Change 1973 Requirements вЂў вЂў вЂў вЂў Complaints about вЂњweekendвЂќ programs Complaints about un-employability Complaints by patients Advisory committee urging History of the Regulations вЂўCLTAC , Clinical Laboratory Technology Advisory Committee вЂ“ prominent members, respected opinions, research of issues/areas of concern, valuable findings, highly regarded by CDPH вЂўCLTAC findings вЂ“ natвЂ™l standards = 40 вЂ“ 120 hrs of training, natвЂ™l certif is voluntary, most labs expand training reqmts, many labs require natвЂ™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: вЂў Palo Alto phlebotomist confessed to reusing needles вЂў Widespread re-testing of patients вЂў High visibility press coverage вЂў Great public concern вЂў Criticism of CDPH for poor standards MIGDEN PHLEBOTOMY LEGISLATION (AB 1557) вЂў вЂў вЂў вЂў вЂў вЂў вЂў вЂў вЂў 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 вЂў Authorizes CDPH to charge fees Overview of New Regulations R-16-99 3 Key elements 1. 3 Year phase-in (to obtain certificate) for вЂњon-thejob-experienceвЂќ = 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 =вЂњGrandfatheringвЂќ 3 Year Phase-In To Obtain Certificate вЂў On-The-Job-Experience (OTJE) - Paid or volunteer - 1 Hour or more вЂў 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 вЂў > 1040 hours of OTJE - requires 20 hours of advanced didactic instruction from a CDPH-LFS approved phlebotomy training program вЂў < 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 вЂў Must obtain at least 3 hours /year вЂў Must show proof of CE with renewal application - Biannual renewal - 2 years - 2 years = 6 hours with renewal application вЂў Existing CE providers will be those CDPH approved Clinical Lab Scientists (CLS) CE providers вЂў 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 вЂў Requirements for phlebotomy training programs & approval process by CDPH-LFS вЂў Requirements for certifying organizations to give exams & approval process by CDPH-LFS NEW CATEGORY OF LAB PERSONNEL вЂў Phlebotomist Defined as a person who collects blood for clinical laboratory test or examination purposes LEVELS OF CERTIFICATION вЂњLimited PTвЂќ - skin puncture only вЂњCPT 1вЂќ - skin plus venipuncture вЂњCPT 2вЂќ - skin plus veni plus arterials All levels: Education must be HS or equivalent LIMITED PHLEBOTOMY TECHNICIAN вЂўRestricted to skin punctures вЂўHS or equivalent вЂў20 hours basic didactic вЂў25 skin punctures in a clinical setting вЂўTraining certified by MD, CLB, CLS, PA or RN вЂўNo examination вЂўState certification plus CE CERTIFIED PHLEBO TECH I No experience вЂўHS or equivalent вЂў40 hours didactic - basic & advanced вЂў40 hours practical in clinical setting вЂў50 venipunctures + 10 skin punctures вЂўExamination by approved certifying organization вЂўState certification and CE CERTIFIED PHLEBO TECH I <1040 hours of OTJE at time of application to LFS вЂўHS or equivalent вЂў40 hours didactic - basic & advanced вЂўDocumentation of OTJE experience within previous five years including вЂњ50 + 10вЂќ вЂўExamination by approved certifying organization вЂўState certification and CE CERTIFIED PHLEBO TECH 1 1040 or more hours of OTJE at time of application to LFS вЂўHS or equivalent вЂў20 hours advanced didactic вЂўDocumentation of OTJE within previous five years including вЂњ50 + 10вЂќ вЂўExamination by approved certifying organization вЂўState certification plus CE CERTIFIED PHLEBO TECH 2 вЂўSkin + venipunctures + arterials вЂўHS graduation or GED вЂўCPT I or meets requirements of CPT I вЂўDocumentation of training - 1040 hours of OTJE in phlebotomy within previous five years вЂўMinimum of 20 supervised arterials by MD, PA, RN, RCP, CLS вЂўState certification and CE SCOPE OF PRACTICE Common Elements вЂў Maintain a current, valid certification with CDPH вЂў Employed by a clinical lab or public health dept вЂў Perform punctures under supervision - licensed MD, PA, CLB, RN, CLS, or their designee licensed or certified under Chapter 3 вЂў Subject to monthly review by supervisor вЂў Demonstrate competency after employment - yearly SCOPE OF PRACTICE Common Elements вЂў Post current state certificate at work location вЂў Carry ID card when away from posted location вЂў No direct and constant supervision required; remote supervision allowed вЂў Supervisor shall be accessible by on-site, telephone or electronic communication вЂў CPT II must perform arterials only when licвЂ™d persons present вЂў 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? вЂўCalifornia licensed clinical laboratory вЂўUS military medical lab specialist program вЂўAccredited US College/University вЂўAdult Education and ROP вЂўPrivate, post-secondary or occupational program registered or approved by BPPVE вЂўNational Accrediting Agency for Clinical Laboratory Sciences (NAACLS) WHO? вЂў Director = MD, CLB, CLS, PA or RN вЂў 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? вЂўDidactic (Classroom) Instruction вЂўMinimum 20 hours вЂњBasicвЂќ вЂўMinimum 20 hours вЂњAdvancedвЂќ вЂўTotal 40 hours вЂўPractical (hands on ) Instruction вЂўClinical setting with real patients вЂўTraining: from test requisition to disposal of sharps вЂўMinimum 40 hours вЂўAssures students complete 50 venipunctures and 10 skin punctures during or after the practical instruction DIDACTIC TRAINING --20 HOURS вЂњBASICвЂќ вЂў Infection control and safety, universal precautions вЂў Circulatory system, Basic anatomy & physiology вЂў Medical terminology вЂў Patient & specimen identification вЂў Selecting & preparing skin puncture site & antiseptic вЂў Blood collection equipment, proper order of the tubes, anticoagulant вЂў Post Puncture Care вЂў Medical waste and sharps DIDACTIC TRAINING --20 HOURS вЂњADVANCEDвЂќ вЂў Advanced infection control & biohazards вЂў Pre-analytical sources of error in specimen collection вЂў Anatomical site selection & patient preparation вЂў Risk factors & complications вЂў Anticoagulation Theory вЂў Corrective actions to take with phlebo & specimen processing вЂў Problem solving вЂў Communications, stress, behavior, ethics вЂў QA in phlebotomy practice PRACTICAL TRAINING --40 HOURS вЂў Clinical Setting вЂў Access to real patients вЂў Equipment вЂў Patient preparation / Infection Control вЂў Blood collection from various ages, health & weight вЂўPost puncture care вЂў Blood processing after collection, centrifugation вЂў Disposal of waste & sharps вЂўPractical Exam вЂўNo arterials drawn, just observe PROGRAM MUST PROVIDE CERTIFICATE OF COMPLETION вЂў Given upon satisfactory completion of training вЂў 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 вЂў Program must maintain a copy of the certificate for 5 years LFS MUST APPROVE PHLEBOTOMY TRAINING PROGRAM вЂў 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 вЂў 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 вЂў Timeframes for Approval: - Processing ranges from 30 - 150 days - Average is 90 days вЂў Approval given for 2 years вЂў CDPH may conduct On-Site Inspection to verify compliance вЂў Renewal Application - Must submit at least 60 days before expiration вЂў 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 вЂў National certification examinations вЂў Exams given by Certifying organizations вЂў Organizations must be approved by CDPH-LFS on and after the effective date of the regulations, that is April 9, 2003. CERTIFYING ORGANIZATIONS вЂў Nationally recognized вЂў Independent, Not-for-profit вЂў Currently 10 organizations MAY qualify for LFS approval вЂў Will issue certificate to phlebotomists and notify CDPH-LFS CERTIFYING ORGANIZATION EXAMINATION вЂў вЂў вЂў вЂў вЂў 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) вЂў Ensure security during exam вЂў Make all examinee records available to CDPH-LFS вЂў Maintain records for minimum of 5 years Overview of New Regulations R-16-99 3 Steps to achieve State certification вЂў Attend an approved phlebotomy training program to complete coursework вЂў Take an exam from an approved certifying organization вЂў Apply to LFS to obtain a certificate as a вЂњLimited Phlebotomy TechnicianвЂќ or a вЂњCertified Phlebotomy TechnicianвЂќ -- 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 вЂў Any вЂњOn-the-job-experience ? OTJE = вЂњGrandfathering ClauseвЂќ to allow 3 year Phase-In вЂў 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 вЂў Decide which level of certification to obtain вЂў Obtain certificate after successful completion of courses вЂў Submit copy of certificate with CPT application to LFS STEP # 2 PASS PHLEBOTOMY CERTIFICATION EXAM OFFERED BY AN APPROVED CERTIFYING ORGANIZATION вЂў Must take and pass the CPT examination from only an approved certifying organization вЂў No вЂњLimited PTвЂќ examination required вЂў Obtain certificate after passing the examination вЂў Submit copy of certificate with CPT application to LFS STEP # 3 LFS ISSUES LIMITED & CPT CERTIFICATES вЂў Submit $54, 2 passport size photos and completed application with documentation of: - HS education or equivalent - Phlebotomy training program certificate - Certifying organization certificate вЂў State will issue certificate and wallet size ID card within 90 days вЂў Renewal biannually (2 years) with proof of 6 CE hours (3 hours x 2 yrs) WHATвЂ™S OUR GOAL? BENEFITS FOR PHLEBOTOMISTS Immediate вЂў If working, 3 years to be certified вЂў Improved public acceptance After State Certification вЂў No more вЂњ5 minute ruleвЂќ вЂў Can work at remote locations вЂў Foundation for advancement вЂў First step in clinical lab career ladder: CPT - MLT - CLS Supervisor - Director вЂў Enhanced employability HURDLES TO CLEAR вЂўMust be employed by a clinical lab or Public Health Dept. вЂўShown competent by supervisor before drawing patients вЂўCE: 3 hours annually or 6 hours biannually вЂўCarry current valid ID card when off site вЂўPay 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 вЂў 90 day вЂњDelayвЂќ period for LFS to receive and review applications from: - training schools - certifying organizations вЂў Old regulations will continue to apply. вЂў 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 вЂ“ cont. January 9 - April 9, 2003 вЂў April 9, 2003 New Regulations become effective and enforceable - Schools are вЂњapprovedвЂќ 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 вЂў PH statute amended вЂ“ requires that public health phlebotomists working in sexually transmitted disease (STD) clinics obtain state certification вЂў Applies to all PH Dept workers who perform phlebotomy вЂ“ mostly STD clinics вЂў Migden bill supersedes older PH laws that allow PH MDвЂ™s to train own phlebotomists without any CDPH certification вЂў PH facilities wishing to train own staff will need to meet training program requirements Public Health STD Phlebotomists вЂў PH and Local County Health Officers reluctant to recognize authority of upcoming regulations, but Department has ruled that Migden bill is the law. вЂў PH Phlebs вЂ“ please do not panic вЂ“ remember the 3 yr вЂњgrandfatheringвЂќ 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 вЂў MAs: must have passed phlebo training as a MA вЂў MA Scope: non-acute, clinic, MD office вЂ“ MD must be present unless free health clinic (PA, NP) вЂў EMT 1- no phleb allowed, EMT 2 & Paramedic - OK вЂў EMT 2 & paramedic: pre-hospital, emergency venue only вЂў If working in clinical lab or hospital as phlebotomist: then working outside scope - must obtain separate phlebotomy certification Foreign or Out-of-State Phlebotomists вЂў Foreign вЂ“ must submit HS/College transcripts translated into English from вЂњTranslation ServiceвЂќ approved for legal or governmental translation, Example: See website: www. phlebotomywest.com вЂў Out-Of-State - Experience will вЂњcountвЂќ - 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?? вЂў Must be clinical labs (BPC 1246) вЂў Broad definition of employer - Wages / pay stub need not originate from lab - Requires lab director oversight & responsibility for phlebotomistsвЂ™ 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 вЂў Non-clinical labs: - OSHA monitoring services (Occupational Health) - Forensics labs, law enforcement contracting services - Insurance company contractors Recent Milestones вЂў November 23, 2001 вЂ“ R-16-99 published in the California Regulatory Notice Register вЂў November 21, 2002 вЂ“ CDPH DirectorвЂ™s approval granted вЂў January 9, 2003 вЂ“ R-16-99 filed with the Secretary of State вЂў April 9, 2003 вЂ“ 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 вЂў вЂў вЂў вЂў вЂў 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 вЂњInstructionsвЂќ sheet вЂў Certifying Organizations вЂў Important Internet Addresses вЂў Persons Authorized to Withdraw Blood ANY BURNING QUESTIONS???