N.J. Admin. Code § 8:44-2.6

Current through Register Vol. 56, No. 21, November 4, 2024

Section 8:44-2.6 - Technical personnel

(a) The clinical laboratory shall have a sufficient number of properly qualified technical personnel for the volume and diversity of tests performed.

(b) The laboratory shall employ a sufficient number of clinical laboratory technologists and/or cytotechnologists to proficiently perform under general supervision the clinical laboratory tests which require the exercise of independent judgment.

(c) Each clinical laboratory technologist shall:

1. Have earned a bachelor's degree in medical technology from an accredited college or university; or

2. Have successfully completed 3 years of academic study (a minimum of 90 semester hours or equivalent) in an accredited college or university, which met the specific requirements for entrance into a school of medical technology accredited by an accrediting agency approved by the Secretary of the United States Department of Health, Education and Welfare, and have successfully completed a course of training of at least 12 months in such a school; or

3. Have earned a bachelor's degree in one of the chemical, physical or biological sciences and, in addition, have at least 1 year of pertinent full-time laboratory experience and/or training in the specialty or subspecialty in which the individual performs tests; or

4. Have successfully completed 3 years (90 semester hours or equivalent) in an accredited college or university with the following distribution of courses:

i. For those whose training was completed prior to September 15, 1963. At least 24 semester hours in chemistry and biology courses of which:

(1) At least 6 semester hours were in inorganic chemistry and at least 3 semester hours were in other chemistry courses; and

(2) At least 12 semester hours in biology courses pertinent to the medical sciences; or

ii. For those whose training was completed after September 14, 1963:

(1) 16 semester hours in chemistry courses which included at least 6 semester hours in inorganic chemistry and which are acceptable toward a major in chemistry; and

(2) 16 semester hours in biology courses which are pertinent to the medical sciences and are acceptable toward a major in the biological sciences; and

(3) Three semester hours of mathematics; and

iii. Have experience and/or training covering several fields of medical laboratory work of at least 1 year and of such quality as to provide him with education and training in medical technology equivalent to that described in paragraphs 1 and 2 of this subsection; or

5. With respect to individuals first qualifying prior to July 1, 1971; the technologist:

i. Was performing the duties of a clinical laboratory technologist at any time between July 1, 1961, and January 1, 1968; and

ii. Has had at least 10 years of pertinent clinical laboratory experience prior to January 1, 1968. (This required experience may be met by the substitution of education for experience); or

6. Achieved a satisfactory grade in a proficiency examination approved by the Secretary of the United States, Department of Health, Education and Welfare.

(d) Each laboratory cytotechnologist shall:

1. Have successfully completed 2 years in an accredited college or university with at least 12 semester hours in science, 8 hours of which are in biology, and

i. Have had 12 months of training in a school of cytotechnology accredited by an accrediting agency approved by the Secretary of the United States Department of Health, Education and Welfare; or

ii. Have received 6 months of formal training in a school of cytotechnology accredited by an accrediting agency approved by the Secretary and 6 months of full-time experience in cytotechnology in a laboratory acceptable to the pathologist who directed such formal 6 months of training; or

2. Prior to January 1, 1969, have:

i. Been graduated from high school;

ii. Completed 6 months of training in cytotechnology in a laboratory directed by a pathologist or other physician recognized as a specialist in cytology; and

iii. Completed 2 years of full-time supervised experience in cytotechnology; or

3. Achieved a satisfactory grade in a proficiency examination approved by the Secretary of the United States, Department of Health, Education and Welfare.

(e) Clinical laboratory technicians shall be employed in sufficient number to meet the workload demands of the laboratory and shall function only under direct supervision of a clinical laboratory technologist.

1. Each technician shall perform only those clinical laboratory procedures which require a degree of skill commensurate with the education, training, and technical abilities and which involve limited exercise of independent judgment.

2. No clinical laboratory technician shall perform procedures in the absence of a qualified clinical laboratory technologist, supervisor, or director.

3. A technician trainee shall perform only those procedures under the personal and direct supervision of a qualified supervisor or technologist for which the trainee has received formal instruction and has demonstrated competency.

(f) Each clinical laboratory technician shall meet one of the following requirements:

1. Have successfully completed 60 semester hours of academic credit including chemistry and biology as well as a structured curriculum in medical laboratory techniques at an accredited institution or have an associate degree based on a course of study including those subjects from an accredited institution;

2. Is a high school graduate or equivalent and has completed at least 1 year in a technician training program in a school accredited by an accrediting agency approved by the Secretary of the United States, Department of Health, Education and Welfare; and/or the N.J. State Board of Higher Education;

3. Is a high school graduate or equivalent and has 2 years of pertinent full-time laboratory experience as a technician trainee in an approved clinical laboratory;

4. Is a high school graduate or equivalent and has successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and has held the military enlisted occupational specialty of Medical Laboratory specialist (Laboratory Technician).

(g) There shall be written personnel policies, practices, and procedures that adequately support sound laboratory practice.

1. Current employee records shall be maintained and include a resume of each employee's training, experience, duties, and date or dates of employment.

2. Files shall contain evidence of adequate health supervision of employees, such as results of preemployment physical examinations, including P.P.D. tuberculin test followed by chest X-rays when indicated, immunization records, and records of all illnesses and accidents occurring on duty.

3. Work assignments shall be consistent with qualifications.

N.J. Admin. Code § 8:44-2.6