N.J. Admin. Code § 8:44-2.5

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

Section 8:44-2.5 - Tests performed

(a) The clinical laboratory shall perform only those laboratory tests and procedures that are within the specialties or subspecialties for which the laboratory is licensed.

(b) All clinical laboratories shall enroll and successfully participate in a proficiency testing program provided by either the Department of Health and Senior Services, or by a proficiency testing provider that the Centers for Medicare and Medicaid Services (CMS) has approved to perform proficiency testing pursuant to the Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. § 263a, and the regulations CMS promulgates pursuant thereto at 42 CFR Part 493.

1. A list of CMS-approved proficiency testing providers is available at http://www.cms.hhs.gov/CLIA/downloads/ptlist.pdf, as amended and supplemented, or upon request to the Department.

2. Enrollment in a proficiency testing program with a provider other than the Department pursuant to (b) above shall encompass all clinical laboratory specialties, analytes and/or subspecialties for which a given laboratory is approved to perform tests that the Department has designated as requiring proficiency testing.

3. Laboratories shall:

i. Enroll and participate in proficiency testing surveys appropriate to their level of service;

ii. Receive and examine and/or analyze specimens delivered by mail or messenger, at such times as designated by the proficiency testing provider; and

iii. Maintain records of all proficiency testing results in surveys in which they participate and make such records, including results, interpretations and cumulative performance data routinely available to the Department of Health and Senior Services.

4. The Department of Health and Senior Services shall reserve authority to regrade data from proficiency testing providers other than the Department (that is, survey scores and cumulative performance interpretations) through the Clinical Laboratory Improvement Service according to its own licensing standards.

5. Any report issued by proficiency testing providers other than the Department by itself shall not be construed as determinative of compliance with the New Jersey licensing standards.

6. An exception to the enrollment requirements of this subsection may be made, provided the Department of Health and Senior Services determines that an appropriate proficiency testing survey is not readily available.

(c) The laboratory shall perform only those laboratory procedures and tests that are within the specialties or subspecialties in which the laboratory director or supervisors are qualified.

1. If the laboratory director or supervisor is a physician certified in anatomical and/or clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possesses qualifications which are equivalent to those required for certification (board eligible), the laboratory may perform anatomical and clinical laboratory procedures and tests in all specialties.

2. If the requirements of paragraph 1 of this subsection are not met and the laboratory performs tests in the specialty of microbiology, including the subspecialties of bacteriology, virology, mycology, and parasitology, the director or a supervisor:

i. Holds an earned doctorate or master's degree in microbiology from an accredited institution or is a physician; and

ii. Subsequent to graduation has had at least 4 years of experience in clinical microbiology.

3. If the requirements of paragraph 1 of this subsection are not met and the laboratory performs tests in the specialty of serology, the director or a supervisor:

i. Holds an earned doctoral or master's degree in biology, chemistry, immunology, or microbiology from an accredited institution or is a physician; and

ii. Subsequent to graduation has had at least 4 years experience in serology.

4. If the requirements of paragraph 1 of this subsection are not met and the laboratory performs tests in the specialty of hematology, including gross and microscopic examination of the blood, the director or a supervisor:

i. Holds a master's or a bachelor's degree in biology, immunology, microbiology, or chemistry, or medical technology from an accredited institution; and

ii. Subsequent to graduation has had at least 4 years of experience in hematology.

5. If the requirements of paragraph 1 of this subsection are not met and:

i. The laboratory performs tests in the specialty of immunohematology, the director or a supervisor is a physician with at least 2 years of experience in immunohematology subsequent to graduation; or

ii. Within the specialty of immunohematology, the laboratory performs tests in the subspecialties of ABO grouping and Rh typing, antibody detection, identification, and titering only, the director or a supervisor holds a master's or bachelor's degree in biology, immunology, microbiology, chemistry, or medical technology from an accredited institution and subsequent to graduation has had at least 4 years of experience in immunohematology.

6. If the requirements of paragraph 1 of this subsection are not met and the laboratory performs tests in the specialty of clinical chemistry, the director or a supervisor:

i. Holds an earned doctoral or master's degree in chemistry from an accredited institution or is a physician; and

ii. Subsequent to graduation has had at least 4 years of experience in clinical chemistry.

7. If the requirements of paragraph 1 of this subsection are not met and the laboratory performs tests in the specialty of radioassay, the director or a supervisor:

i. Holds an earned doctoral, master's or bachelor's degree in chemistry, physics, biology, or medical technology from an accredited institution or is a physician; and

ii. Subsequent to graduation has had at least 4 years of experience in radioassay.

8. If the requirements of paragraph 1 of this subsection are not met and the laboratory performs tests in the specialty of diagnostic cytology, the director or a supervisor:

i. Is a physician who is certified by the American Society of Cytology to practice cytopathology or possesses qualifications which are equivalent to those required for certification (under this provision the laboratory is qualified to perform such tests only on that anatomic site for which the director or supervisor is certified); or

ii. Is an individual who, pursuant to a request to establish his qualified filed prior to January 1, 1971, has demonstrated competency:

(1) Through at least 7 years of accumulative experience in a position of diagnostic responsibility in the field of clinical cytology, or through 5 years of full-time training in diagnostic clinical cytology with suitable endorsement by a physician who has been supervisor in such activity;

(2) By the publishing of treatises, texts, or other publications on the subject of diagnostic cytology which are generally acknowledged and recognized by the medical profession as authoritative in the field;

(3) By appointment to and service in pertinent teaching and research positions in recognized schools of medicine;

(4) By acceptance into or award of membership and office in professional societies in this field; and

(5) By receipt of other professional honors for excellence in the use of procedures in exfoliative cytology for the diagnosis of a pathological condition (under this provision the laboratory is qualified to perform such tests only on that anatomic site with respect to which such competency is so established). An individual who qualified under this paragraph is deemed also to meet the requirements of paragraph 1 of this subsection.

9. An exception to the requirements in paragraphs 2 through 7 of this subsection is made with respect to an individual who qualifies as a director under paragraph 3 of this subsection. The laboratory such individual directs may perform tests in the following:

i. Microbiology: If the director has a bachelor's degree in a biological science and subsequent to graduation has had at least 6 years of experience in microbiology;

ii. Hematology: If the director has a bachelor's degree in biology, immunology, or microbiology from an accredited institution and subsequent to graduation has had at least 6 years of clinical laboratory experience of which at least 4 years of experience are in hematology;

iii. Serology: If the director has a bachelor's degree in biology, chemistry, immunology, or microbiology and subsequent to graduation has had at least 6 years of experience in serology;

iv. In vitro Radioassay: If the director has a bachelor's degree in a chemical, physical, or biological science and subsequent to graduation has had at least 6 years of laboratory experience, at least 1 year of which is in radioassay;

v. Blood grouping and Rh typing, antibody detection, identification, and titering: If the director has a bachelor's degree in biology, immunology, or microbiology from an accredited institution and subsequent to graduation has had at least 6 years of clinical laboratory experience of which at least 4 years of experience are in immunohematology;

vi. Clinical chemistry: If the director has a bachelor's degree in a chemical science or its equivalent and subsequent to graduation has had at least 6 years of experience in clinical chemistry;

vii. Any of the above specialties: If the director has a bachelor's degree in medical technology and subsequent to graduation has had at least the designated years of specialized experience.

N.J. Admin. Code § 8:44-2.5

Amended by R.1995 d. 239, effective 5/15/1995.
See: 27 N.J.R. 626(a), 27 N.J.R. 1985(a).
Amended by R.2007 d.322, effective 10/15/2007.
See: 39 N.J.R. 1978(a), 39 N.J.R. 4397(b).
Rewrote (b).