Cal. Code Regs. Tit. 17, § 1035 - Phlebotomy Training Program Requirements

(a) In order to be eligible for approval by the department to provide didactic and/or practical phlebotomy instruction leading to certification of phlebotomists, a phlebotomy training program shall meet the requirements of this section and be offered by either a:

(1) National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) approved program for training phlebotomists; or

(2) Accredited college or university; or

(3) Private, post-secondary program or occupational program registered or approved by the Bureau for Private Postsecondary and Vocational Education; or

(4) California Adult Education or Regional Occupational Program (ROP); or

(5) United States of America military medical laboratory specialist program; or

(6) California licensed clinical laboratory.

(b) A phlebotomy training program shall be directed by a licensed physician and surgeon, licensed physician assistant, registered nurse, or person licensed under Chapter 3, who shall be responsible for:

(1) Overall operation and administration of the phlebotomy training program; and

(2) Ensuring the quality of the technical, scientific and clinical instruction; and

(3) Ensuring that the person(s) providing instruction meets the qualifications of this section; and

(4) Ensuring that the person(s) providing instruction is competent and that his or her work performance is periodically evaluated, monitored and documented.

(c) The person(s) providing instruction shall be a:

(1) Licensed physician and surgeon; or

(2) Licensed physician assistant; or

(3) Registered nurse; or

(4) Person licensed under Chapter 3; or

(5) Respiratory care practitioner with a minimum of 2 years experience in the previous 5 years; or

(6) Certified phlebotomy technician with a minimum of 3 years of experience in the previous 5 years or a phlebotomist with 3 years of experience in the previous 5 years and employed as a phlebotomy instructor, who shall meet certification requirements pursuant to Section 1030(a)(4) on or before December 31, 2003.

(d) Person(s) specified in Subsection (c)(1) through (5) shall pass a written examination in phlebotomy, administered by a certifying organization approved by the department pursuant to Section 1031.7 either:

(1) Prior to employment by a phlebotomy training program approved by the department pursuant to this section; or

(2) No later than December 31, 2003, if employed as a phlebotomy instructor on or before April 9, 2003.

(e) An approved phlebotomy training program shall provide the following didactic instruction to its students:

(1) A basic phlebotomy curriculum consisting of a minimum of 20 hours lecture and testing for knowledge of:

(A) Basic infection control, universal precautions and safety; and

(B) Basic anatomy and physiology of body systems with emphasis on the circulatory system, the appropriate medical terminology; and

(C) Proper identification of patient and specimens, the importance of accuracy in overall patient care; and

(D) Proper selection and preparation of skin puncture site, including selection of antiseptic; and

(E) Blood collection equipment, types of tubes and additives, proper order of draw when additives are required, special precautions; and

(F) Post-puncture care; and

(G) Appropriate disposal of sharps, needles and waste.

(2) An advanced phlebotomy curriculum consisting of a minimum of 20 hours of lecture and testing for knowledge of:

(A) Advanced infectious disease control and biohazards; and

(B) Anti-coagulation theory; and

(C) Knowledge of pre-analytical sources of error in specimen collection, transport, processing and storage; and

(D) Anatomical site selection and patient preparation; and

(E) Risk factors and appropriate responses to complications which may arise from phlebotomy; and

(F) Recognition of, and corrective actions to take, with problems in test requisitions, specimen transport and processing; and

(G) Applications of basic concepts of communication, interpersonal relations, stress management, professional behavior, ethics and legal implications of phlebotomy; and

(H) Quality assurance in phlebotomy necessary to provide accurate and reliable laboratory test results; and

(I) Legal issues related to blood collection.

(f) An approved phlebotomy training program shall provide a clinical setting for a minimum of 40 hours of practical instruction in phlebotomy.

This setting shall provide access to patients whose blood is being tested by a clinical laboratory. In order for a program to be eligible for approval by the department, it shall provide documentation of a training curriculum that includes:

(1) Selection of blood collection equipment appropriate to test requisitions; and

(2) Preparation of the patient and infection control; and

(3) Skin punctures for testing purposes from patients of varying ages, including pediatric and geriatric, and of varying health and obesity status; and

(4) Venipunctures from patients of varying ages, health and obesity status; and

(5) Post-puncture care; and

(6) Processing of blood containers after collection, including centrifugation; and

(7) Proper disposal of needles, sharps and medical waste; and

(8) Observation of arterial punctures; and

(9) A practical examination showing evidence of successful completion of Subsections (f)(1) through (7).

(g) A phlebotomy training program shall be responsible for assuring that a student completes a minimum of 10 skin punctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements and 50 venipunctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of all clinical laboratory tests or examinations during or after his or her practical instruction.

(h) A phlebotomy training program shall provide a certificate of completion to its students upon satisfactory completion of the program.

The program shall maintain a copy of this certificate for five years. This certificate shall be signed by the director of the program and shall include:

(1) Name and address of the training program; and

(2) Name of the student; and

(3) Statement of satisfactory completion of the program; and

(4) Dates that training began and ended.

(i) A phlebotomy training program seeking approval from the department shall provide documentation to substantiate that its program objectives meet training criteria stated in this section. Verification may include an on-site inspection of the program.

(j) A complete application for phlebotomy training program approval shall include the following:

(1) Name and address of the training program; and

(2) Location(s) of all sites where didactic and practical instruction occur; and

(3) Name(s) and license number(s) of the physician and surgeon, physician assistant, registered nurse, or person licensed under Chapter 3 who is directing the program; and

(4) Name(s), license number(s) or certificate number(s), experience in phlebotomy, and evidence of satisfactory performance on a phlebotomy certification examination administered by a certifying organization with departmental approval in effect at the time the examination was administered, of every physician and surgeon, physician assistant, registered nurse, person licensed under Chapter 3, respiratory care practitioner, certified phlebotomy technician, or phlebotomist pursuant to Subsection (c)(6) who is supervising or providing instruction; and

(5) List of equipment, supplies and educational materials used for instruction; and

(6) Curriculum and instructional objectives, including hours spent at each activity.

(k) Timeframes for approval of training programs shall be as follows:

(1) Submission of an application for approval shall be deemed to occur on the date the complete application is received by the department.

(2) Written notification by the department to the applicant shall be considered to occur on the date the documents are postmarked.

(3) The department shall notify the applicant within 60 days of submission of an application for training program approval, of one of the following:

(A) That the application is complete and acceptable for processing by the department; or

(B) That the application is incomplete and not accepted for processing. This notification shall include the specific information or documentation that the applicant shall submit within 30 days in order for the department to consider the application acceptable; or

(C) That the application has been reviewed and does not meet the requirements of this section and that approval is denied.

(4) The department shall consider an application to have been abandoned by any applicant who fails to respond to the department's request to submit specific information or documentation within 30 days of notification pursuant to Section 1035(k)(3)(B).

(5) The department's time periods for processing an application, from the date the initial application is received to the date the final decision is made regarding approval, are as follows:

(A) The median time for processing an application is 90 days.

(B) The minimum time for processing is 30 days.

(C) The maximum time for processing is 150 days.

(l) Approval shall be valid for a two-year period.

(m) To apply for renewal, a training program shall file a renewal application at least 60 days prior to the end of the approval period and provide the following:

(1) The name and address of the training program; and

(2) The name and license number of all directors; and

(3) The name, license or certificate number of all instructors; and

(4) The name(s) and location(s) of all didactic and practical instruction; and

(5) The curriculum and instructional objectives, including hours spent at each activity; and

(6) The schedule of didactic and practical instruction for the next 24 months; and

(7) The listing of students who completed its program and the total number of students who enrolled in its program in the previous approval period; and

(8) The signature of the director(s) and date of the application for renewal.

(n) Failure to meet the requirements of this section shall be good cause for denial or revocation of approval by the department.

(o) The training program shall notify the department in writing of any change(s) in the information and material required by Subsections (a) through (h) within 30 days after the change(s) has occurred.

Notes

Cal. Code Regs. Tit. 17, § 1035

1. Amendment filed 10-22-57; effective thirtieth day thereafter (Register 57, No. 18).
2. Amendment filed 10-1-62; effective thirtieth day thereafter (Register 62, No. 21).
3. Amendment filed 5-18-64; effective thirtieth day thereafter (Register 64, No. 11).
4. Repealer and new section filed 12-28-71; effective thirtieth day thereafter (Register 72, No. 1).
5. Change without regulatory effect renumbering former section 1035 to section 1035.2 and renumbering former section 1035.1 to section 1035, including amendments, filed 10-6-2022 pursuant to section 100, title 1, California Code of Regulations (Register 2022, No. 40).

Note: Authority cited: Sections 1224 and 1320, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1208, 1220, 1222, 1222.5, 1242, 1242.5, 1246, 1269 and 1300, Business and Professions Code; and Section 120580, Health and Safety Code.

1. Amendment filed 10-22-57; effective thirtieth day thereafter (Register 57, No. 18).
2. Amendment filed 10-1-62; effective thirtieth day thereafter (Register 62, No. 21).
3. Amendment filed 5-18-64; effective thirtieth day thereafter (Register 64, No. 11).
4. Repealer and new section filed 12-28-71; effective thirtieth day thereafter (Register 72, No. 1).
5. Change without regulatory effect renumbering former section 1035 to section 1035.2 and renumbering former section 1035.1 to section 1035 filed 10-5-2022 pursuant to section 100, title 1, California Code of Regulations (Register 2022, No. 40).