Senate Bill No. 651

(By Senator Hunter)

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[Introduced February 22, 1999; referred to the Committee on Health and Human Resources; and then to the Committee on Finance.]

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A BILL to amend chapter sixteen of the code of West Virginia, one thousand nine hundred thirty-one, as amended, by adding thereto a new article, designated article five-q, relating to public health; providing for a phlebotomy certification training program; and requiring that the drawing of blood be done only by a phlebotomist.

Be it enacted by the Legislature of West Virginia:
That chapter sixteen of the code of West Virginia, one thousand nine hundred thirty-one, as amended, be amended by adding thereto a new article, designated article five-q, to read as follows:
ARTICLE 5Q. PHLEBOTOMIST SERVICES.

§16-5Q-1. Legislative findings.
The Legislature finds that although most health care professionals are required by the state of West Virginia to maintain standardized levels of education and training, as regulated through licensure requirements, there is currently no such requirement for phlebotomy technicians. Becoming a phlebotomist in West Virginia has typically consisted of on-the-job training in what health care professionals refer to as "See One, Do One, Teach One," whereby the employee-trainer often transfers his or her own poor technique and procedural errors to the employee-trainee.
Whereas a phlebotomist is often the first health care professional to perform an invasive procedure on the patient, an improperly performed phlebotomy procedure reflects poorly upon the entire health care facility and its staff. An inadequately trained phlebotomist is a hazard to himself or herself and others within the health care facility, increasing the risk of needle stick and infection and can be an agent for the spread of infection to the entire community. It is commonplace for an inadequately trained phlebotomist to perform multiple unnecessary phlebotomy procedures on a patient in an attempt to obtain one test specimen. Improperly performed phlebotomy procedures can contribute to the spread of nosocomial infection, traumatize or seriously injure the patient, produce erroneous test results, lead to misdiagnosis and even direct the physician toward an ineffective course of treatment. Delaying appropriate treatment increases the cost of health care, putting an additional burden on patients, providers of health care insurance and the medicaid and medicare systems.
§16-5Q-2. Definitions.
"Certified Phlebotomy Technician" means an individual who performs phlebotomy procedures and has met recognized minimum training and certification standards.
"Indwelling Lines" means previously-existing access lines (i.e. catheters for intravenous therapy, shunts for dialysis, arterial lines, etc.)
"Invasive Procedure" means one in which the patient's bodily tissues are penetrated by a sharp instrument.
"Needle Stick" typically means an accidental insertion of the sharp point of a needle or other instrument into the body of a health care worker or other individual potentially introducing an infectious substance into that person.
"Nosocomial Infection" means infection contracted by a patient while receiving care in a health care facility.
"Phlebotomist or Phlebotomy Technician" means an individual who performs phlebotomy procedures.
"Phlebotomy or a Phlebotomy Procedure" means the clinical procedure performed by a phlebotomist for the purpose of withdrawing blood for clinical laboratory testing. (The word phlebotomy comes from the Greek roots phleb, vein and -otomy, to cut; literally, to cut into a vein.)
"Trauma" means a physical injury that has a lasting psychic or physical effect.
"Venipuncture" means the insertion of a hollow needle into a vein.
"Venipuncture Procedure" means a procedure, in phlebotomy, performed for the purpose of withdrawing a sample of venous blood for testing.
§16-5Q-3. Certification.
An unlicensed person employed for the purpose of withdrawing human blood for test purposes upon specific authorization from a clinical laboratory or a licensed physician and surgeon may perform venipuncture and skin puncture procedures provided that person has successfully completed an approved phlebotomy certification training program. An approved phlebotomy certification training program must train and certify unlicensed or licensed persons in the proper procedure to be employed in the performance of venipuncture and skin puncture procedures.
§16-5Q-4. Designation.
(a) An unlicensed person entering a health care position in West Virginia who will perform phlebotomy procedures as outlined in this article must successfully complete an approved phlebotomy certification training program, or must receive a waiver prior to performing phlebotomy procedures on patients and is referred to as a certified phlebotomy technician.
(b) An unlicensed health care worker currently performing phlebotomy procedures on patients within West Virginia must satisfy state phlebotomy certification requirements in one of the following ways:
(1) The unlicensed person has, during the last three years, received documented training equal to or exceeding the standards required in section five of this article, and is called a certified phlebotomy technician and must utilize the training documentation as a waiver of the training requirement in section five of this article.
(2) The unlicensed person has not received equivalent training and is granted a grace period of twelve months, during which time the unlicensed person must complete the minimum training requirements and obtain a phlebotomy certification through an approved provider in one of the following ways:
(i) The unlicensed person may complete the phlebotomy training and certification program of an approved provider.
(ii) The unlicensed person is permitted to challenge the written examination and the clinical training requirements of an approved provider. The unlicensed person who satisfactorily completes the written examination and clinical evaluation of an approved provider is granted a phlebotomy certification and is called a certified phlebotomy technician.
§16-5Q-5. Approved phlebotomy certification training program.
(a) The West Virginia office for laboratory services, an office of the bureau of public health, shall administer the provisions of this article. The office for laboratory services must approve providers of phlebotomy certification training programs and must require that the providers follow the training guidelines established in this article prior to issuing a provider number. The office for laboratory services retains the right to audit approved providers, employers and unlicensed persons employed to perform phlebotomy procedures to ensure compliance with standards of phlebotomy certification training programs. To cover administrative expenses, the office for laboratory services may charge phlebotomy certification training program providers no more than twenty-five dollars as an initial application fee and annually as a renewal fee.
(b) An approved provider of a phlebotomy certification training program must satisfy all of the following requirements and an approved provider must satisfy at least one of the following qualifications:
(1) Possession of a graduate degree in a scientific field of study of registered nursing or higher and have no less than three years of experience performing phlebotomy procedures in an inpatient hospital setting within the last ten years; or
(2) Possession of a graduate degree in a scientific field of study of registered nursing or higher and no less than six years of experience performing phlebotomy procedures in an inpatient hospital setting; or
(3) Possession of a minimum of six years of phlebotomy experience and at least three years of said experience in a supervisory capacity in an inpatient hospital setting within the last ten years.
(c) The approved provider must personally supervise and teach the phlebotomy certification training program or may designate a qualified substitute instructor to supervise and instruct the phlebotomy certification program in the absence of the provider.
(d) The approved provider must instruct the phlebotomy certification training program using the following guidelines:
(1) A minimum of ten clock hours of an approved phlebotomy certification training program is acceptable and must include:
(A) Lecture and instruction with: (i) Pertinent anatomy, physiology and histology; (ii) proper skin-puncture procedure and technique; (iii) proper venipuncture procedure and technique; (iv) post-puncture patient care; (v) choice of equipment; (vi) common laboratory tests, tubes, additives; (vii) indwelling lines; (viii) infection control and isolation procedures; (ix) hazards and complications; (x) care of specimen; (xi) documented performance by the unlicensed person or at least three successful venipunctures; and (xii) documented performance by the unlicensed person of at least three successful venipunctures.
(B) Written evaluation with receipt of a passing score of at least eighty percent on a written examination covering instructed material and consisting of not less than twenty questions.
(e) Upon satisfactory completion of phlebotomy certification training program requirements, the approved provider of a phlebotomy certification training program shall issue an original certificate to the unlicensed person and a copy of the certificate to the office for laboratory services stating the following: (1) The approved training programs name and provider number; (2) the name of the unlicensed person certified; (3) the dates of the training period; (4) the date issued; (5) that the provisions of section eleven, article five-j of this chapter have been satisfied; and (6) the signature of the instructor.
(f) The approved provider of a phlebotomy certification training program must maintain all training records of certified persons for at least five years.
§16-5Q-6. Proof of certification.
The employer must retain a copy of the phlebotomy certification, or waiver thereof as described in section four of this article, of an unlicensed health care worker or licensed health care worker requiring phlebotomy certification.



NOTE: The purpose of this bill is to require that the drawing of blood by an unlicensed health care position be done only by a phlebotomist. To that end, it provides for a phlebotomy certification training program to be approved by the West Virginia Office for Laboratory Services.

This article is new; therefore, strike-throughs and underscoring have been omitted.