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Stuck on Phlebotomy ???

Stuck on Phlebotomy ???. Phlebotomy Regulations: They’re Here!. © BCJ. !CAVEAT!. Contents of these slides are subject to change . 2/04/03 . GOVERNMENT 101. What are Regulations?. Three Branches of Government. Legislative Will of the people Statutes. Executive Administration

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Stuck on Phlebotomy ???

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  1. Stuck on Phlebotomy ??? Phlebotomy Regulations: They’re Here! © BCJ

  2. !CAVEAT! Contents of these slides are subject to change. 2/04/03

  3. GOVERNMENT 101 What are Regulations?

  4. Three Branches ofGovernment Legislative Will of the people Statutes Executive Administration Regulations Judicial Judgment Disputes

  5. 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.

  6. STATUTES are born out of legislation, reflecting the will of the people

  7. 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

  8. Regulations develop and grow through administrative efforts within the Executive Branch

  9. 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

  10. History of the RegulationsCCR Title 17, Section 1034Requirements • 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

  11. 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”

  12. History of the Regulations Efforts to Change 1973 Requirements • Complaints about “weekend” programs • Complaints about un-employability • Complaints by patients • Advisory committee urging

  13. 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

  14. History of the RegulationsREGS STORED AWAY KEEP OUT!

  15. 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

  16. 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

  17. Overview of New Regulations R-16-99 • 3 Key elements • 3 Year phase-in (to obtain certificate) for “on-the- job-experience” = grandfathering clause • Less required phlebotomy training program coursework, if greater than 1040 hours OTJE at the time of application for CA State certification • CE: 6 hours/2 years (3 hours/year) for a 2 year certificate

  18. Key Element #1OTJE =“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

  19. Key Element # 2OTJE = 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 andadvanced didactic instruction from a CDPH-LFS approved phlebotomy training program • - This is the same requirement for didactic instruction as a new phlebotomy student

  20. 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

  21. 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

  22. NEW CATEGORY OF LAB PERSONNEL • Phlebotomist Defined as a person who collects blood for clinical laboratory test or examination purposes

  23. 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

  24. 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

  25. CERTIFIED PHLEBO TECH INo 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

  26. 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

  27. CERTIFIED PHLEBO TECH 11040 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. PHLEBOTOMY TRAINING PROGRAMS WHO? WHAT? WHERE?

  33. 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)

  34. WHO? Director = MD, CLB, CLS, PAor 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.

  35. NEWS FLASH! ALL didactic instructors must successfully pass a phlebotomy exam administered by an approved certifying organization.

  36. 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 WHAT?

  37. 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

  38. 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

  39. 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

  40. 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

  41. 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

  42. 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

  43. 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

  44. 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 exam & approval process by CDPH-LFS

  45. 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.

  46. CERTIFYING ORGANIZATIONS • Currently 10 organizations MAYqualify for LFS approval • Will issue certificate to phlebotomists and notify CDPH-LFS • Nationally recognized • Independent, Not-for-profit

  47. CERTIFYINGORGANIZATIONEXAMINATION • 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

  48. ID CARD Phleb Supreme Certified Phleb Supreme 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

  49. 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

  50. 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

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