Issues Specific to California Clinical Laboratory Law

State of California—Health and Human Services Agency

California Department of Public Health

KAREN L. SMITH, MD, MPH EDMUND G. BROWN JR.

Director and State Public Health Officer Governor

Laboratory Field Services  850 Marina Bay Parkway, Building P, 1

Floor  Richmond, CA 94804

(510) 620-3800

● (510) 620-3692 FAX

Internet Address: www.cdph.ca.gov/lfs

ISSUES SPECIFIC TO CALIFORNIA CLINICAL LABORATORY LAW

California Department of Public Health

Laboratory Field Services

2017

California has the following specific requirements that are unique to State law.

This information is given solely to provide guidance about California clinical laboratory

laws. Laboratory Field Services (LFS) in the California Department of Public Health

does not provide its approval for other content. Please note that LFS does not approve

written material that is not endorsed, signed, and published by LFS staff.

I. LABORATORY DIRECTOR REQUIREMENTS AND RESPONSIBILITIES

A. A California clinical laboratory may have multiple laboratory directors. The person

serving as the CLIA laboratory director must qualify under CLIA. This includes

both licensed and registered clinical laboratories performing non-waived testing.

(BPC § 1209(b))

B. A clinical laboratory must have a laboratory director who is a California-licensed

physician and surgeon, master’s- or doctoral-degree

scientist, or master’s- or

doctoral-degree bioanalyst. This includes registered laboratories performing

waived tests. (Business and Professions Code (BPC) § 1209)(a))

1. A clinical laboratory registered by the California Department of Public Health

must hold either a valid CLIA Certificate of Waiver or a valid CLIA Certificate

of Provider-Performed Microscopy. California-registered laboratories with a

In this document “associate-degree license” refers to any license that requires at least an associate

degree, for example, medical laboratory technician. “Baccalaureate-degree license” refers to any license

that requires at least a baccalaureate degree, for example, clinical laboratory scientist and clinical

laboratory scientist limited to a specialty. “Master’s or doctoral-degree license” refers to any license that

requires at least a master’s or doctoral degree, for example, bioanalyst or director licenses limited to a

specialty.

CLIA Certificate of Waiver that are not part of an acute care hospital may be

directed by a California-licensed clinical laboratory scientist or clinical

laboratory scientist limited to a specialty, a California-licensed naturopathic

doctor, a California-licensed optometrist in a laboratory performing only CLIA-

waived tests necessary for the diagnosis of conditions and diseases of the

eye or adnexa, or the California-licensed pharmacist in-charge, responsible

for directing and supervising testing oversight and decision-making in the

course of pharmacist-performed routine patient assessment procedures.

(BPC §§ 1206.6, 1209(a), 1265, 4036, 4052.4)

2. A licensed or registered clinical laboratory performing tests or examinations in

a single specialty may be directed by a California-licensed master’s or

doctoral-degree scientist licensed to direct a clinical laboratory in his/her

specialty, provided the tests and examinations performed by the laboratory

are limited to the clinical laboratory specialty of the laboratory director. (BPC §

1264)

C. The laboratory director of a general acute care hospital must be a board-certified

pathologist. A licensed physician and surgeon or bioanalyst may serve in the

absence of a pathologist, but a pathologist must be available. (BPC § 1209 (h))

Other non-pathologist physician section directors can serve as technical

supervisors in general acute care hospitals even though they may not qualify as

laboratory directors. (Title 17, California Code of Regulations (17 CCR § 1036.4)

D. A licensed doctoral-degree scientist, for example, a clinical chemist, clinical

microbiologist, or clinical toxicologist, may serve as a laboratory director limited

to his or her specialty. If he or she is serving as the CLIA laboratory director, the

qualifications specified in CLIA also apply. (BPC §§ 1207, 1209 (b), (f), (h), 1264)

E. A licensed bioanalyst may serve as laboratory director of an acute care hospital

laboratory if a qualified pathologist is not available, but a pathologist must be

available for consultation. If he or she is serving as the CLIA laboratory director,

the qualifications specified in CLIA also apply. (BPC §§ 1207, 1209 (b), (f), (h),

1264)

F. A director of a histocompatibility laboratory must be a licensed physician and

surgeon, a bioanalyst, or a doctoral-degree scientist who has four years of

experience in immunology, two of which must have been in histocompatibility

testing. (BPC § 1209.1)

G. An interim laboratory director must be appointed within five days of a major

change of director if a laboratory is left without a director. (BPC § 1265 (e)(2))

H. The owner and director of a laboratory must notify the Department within 30 days

of a major change in laboratory director. (BPC § 1265 (g))

I. A clinical laboratory performing tests in the specialty of cytogenetics must have a

director licensed as a clinical cytogeneticist, pathologist, or bioanalyst who meets

CLIA requirements for laboratory director. If he or she is serving as the CLIA

laboratory director, the qualifications specified in CLIA also apply. (BPC § 1209

(b), 17 CCR §§ 1030.6, 1030.7)

J. A laboratory performing tests in genetic molecular biology must have a director

licensed as a clinical genetic molecular biologist, pathologist, or bioanalyst who

meets CLIA requirements for laboratory director. (17 CCR § 1030.7)

K. An oral pathology laboratory director must be a board-certified pathologist or a

dentist licensed by the Department as an oral pathology laboratory director. (17

CCR § 1030.8)

L. A laboratory director may serve as the director of up to the maximum number of

laboratories stipulated by CLIA. The director must sign all abnormal reports and

all non-gynecological reports, and must be available daily. (BPC § 1209 (j))

M. A laboratory director may direct no more than five non-waived laboratories, but is

not limited in the number of waived laboratories he or she can direct. (BPC §

1209 (j))

N. A laboratory director is excluded from directing another laboratory for two years

when he or she has been the owner, operator, or director of a laboratory that has

had its license revoked. (17 CCR § 1065.30)

II. LABORATORY SUPERVISORS AND CONSULTANTS

A. A general supervisor must be licensed to perform high complexity tests or must

be a California-licensed physician and surgeon, and must have two years of

experience in high-complexity testing in the specialty or specialties he or she is

supervising. The general supervisor must provide day-to-day supervision and

must be accessible. (17 CCR § 1036.1)

B. A technical supervisor must be licensed to perform high complexity testing or

practice medicine in California. A physician and surgeon or doctoral-level

scientist must have one year of experience, a master’s-level scientist, two years,

and a baccalaureate-level scientist, four years of experience. (17 CCR § 1036.4)

C. A clinical consultant must be licensed to direct a clinical laboratory in California or

to practice medicine. (17 CCR § 1036)

D. A moderate complexity technical consultant must be licensed to perform high

complexity testing in California or to practice medicine and must have two years

of experience in moderate or high complexity testing in the specialty or

specialties for which he or she is consulting. (17 CCR § 1036.2)

E. A waived laboratory technical supervisor or technical consultant must be qualified

as a testing person authorized under BPC § 1206.5 (a), must have a

baccalaureate degree, must be a licensed healthcare professional, must have

one year of experience in clinical laboratory testing in those tests or examinations

that he or she will be supervising, and must document competency in the tests

he or she will be supervising. (17 CCR § 1036.3)

III. TESTING PERSONNEL

A. Testing personnel approved to perform each complexity test are listed at BPC §

1206.5.

B. A person performing moderate complexity testing must have at least an

associate degree license. (BPC § 1260.3)

C. A person with an associate degree licensed as a medical laboratory technician

may perform waived and moderate complexity tests and report the results, but

must perform testing under the supervision of a licensed physician and surgeon

or a person with a baccalaureate, masters, or doctoral level license. (BPC §

1260.3)

D. A person performing high complexity testing must have a baccalaureate-level

license, with exceptions for persons with military laboratory training and

experience. (BPC § 1261)

E. A person with a baccalaureate-degree license may serve as technical consultant,

technical supervisor, and general supervisor when the person has adequate

experience or training. (BPC § 1210)

F. A person with a baccalaureate-level license in a specialty may perform waived or

moderate complexity testing in any other specialty. (BPC § 1210).

G. A technical supervisor must be licensed to perform high complexity testing or

practice medicine in California. A physician and surgeon or doctoral level

scientist must have one year of experience, a master’s level scientist, two years,

and a baccalaureate-level scientist, four years of experience. (17 CCR § 1036.4)

H. A licensed baccalaureate-degree scientist may perform high, moderate, and

waived-complexity tests in any specialty or subspecialty, with the exception of

cytology. (BPC § 1204)

I. A licensed clinical chemist scientist may perform high complexity tests in

chemistry, including routine chemistry, clinical microscopy, endocrinology,

toxicology; immunology, including diagnostic immunology and serology, and

molecular biology. (17 CCR § 1031(b)(1))

J. A licensed clinical microbiologist scientist may perform high complexity tests in

microbiology including bacteriology, mycobacteriology, mycology, parasitology,

and virology, immunology, including diagnostic immunology and syphilis

serology, and molecular biology. (17 CCR § 1031(b)(2))

K. A licensed clinical immunohematologist scientist may perform high complexity

tests in immunohematology including ABO/Rh blood grouping and typing,

unexpected antibody detection, compatibility testing and antibody identification.

(17 CCR § 1031(b)(3))

L. A licensed clinical toxicologist scientist may perform high complexity tests in the

specialty of toxicology. (17 CCR § 1031(b)(4))

M. A licensed clinical hematologist scientist may perform high complexity tests in

hematology including routine hematology and coagulation. (17 CCR §

1031(b)(5))

N. A physician office laboratory (five or fewer physicians performing tests only on

their own patients) may employ any person to perform testing, but a supervising

physician must be present onsite when high complexity tests are performed.

(BPC § 1206.5 (c)) A person performing high-complexity tests must have at least

an associate degree in science. (Title 42, Code of Federal Regulations §

493.1489)

IV. UNLICENSED LABORATORY PERSONNEL

A. There are limitations on what activities an unlicensed laboratory personnel can

perform in a laboratory. (BPC § 1269)

B. Unlicensed laboratory personnel may only perform duties in a licensed clinical

laboratory. Unlicensed laboratory personnel may not perform duties in a

registered clinical laboratory. (BPC § 1269)

C. Unlicensed laboratory personnel ("aides") cannot perform tests in a laboratory

that is not a physician office laboratory. (BPC § 1212, BPC § 1206.5)

D. Unlicensed laboratory personnel require direct and constant supervision during

the entire time they are assisting in the activities specified in BPC § 1269 (b).

(BPC § 1206 (a) (9),1269 (a))

E. Unlicensed laboratory personnel require the supervision and control of a licensed

person when performing pre-analytical and post-analytical procedures such as

specimen preparation. (BPC § 1269 (c))

V. LABORATORY OWNERS

A. Anyone with a 5% or more interest in a laboratory is considered an owner. (BPC

§ 1211)

B. If the laboratory director is not the laboratory owner, then both are jointly and

severally responsible for the laboratory. (BPC § 1265 (b))

C. A laboratory owner is excluded from owning another laboratory for two years

when he or she has been the owner, operator, or director of a laboratory that has

had its license or registration revoked. (17 CCR § 1065.30)

D. A major change of ownership is one that involves a change in 50 percent of more

of ownership control. (BPC § 1211)

E. A laboratory’s owners and directors must notify the Department within 30 days of

a change of ownership, directorship, and name, or location, including addition or

deletion of owners or directors. (BPC § 1265 (g))

F. A laboratory owner must state the name(s) and address(es) of owners and

directors on the application for licensure or registration of the facility. (BPC §

1265 (b))

VI. PHLEBOTOMY

A. Phlebotomy can be performed by persons licensed under BPC chapter 3. (BPC §

1242)

B. Phlebotomy can be performed by a licensed registered nurse, licensed

vocational nurse, or licensed respiratory care practitioner. (BPC § 1242.6)

C. Phlebotomy can be performed as part of a necessary training program by a

student enrolled in an accredited college or university or a school approved by

the department for training purposes. (BPC § 1243)

D. Phlebotomy can be performed by a certified phlebotomy technician, who must

a. Be employed by a clinical laboratory (BPC § 1246); or

b. Perform phlebotomy for non-diagnostic (insurance) purposes or for

forensic purposes outside a clinical laboratory, when the certified

phlebotomy technician follows policy and procedures established by a

physician and is supervised by a physician, nurse, or a person licensed

under BPC Chapter 3 including a medical laboratory technician. (BPC §

1246 (c))

E. Certification requirements and scopes of practice for phlebotomy technicians are

listed in California law. (17 CCR § 1034)

F. Instruction and training in phlebotomy for certification purposes must be obtained

in a training school or program approved by the department. (17 CCR §§ 1034

and 1035.1)

VII. TRAINEES

A. A training program must be approved by the Department. (BPC § 1286 and 17

CCR §§ 1035, 1035.1, and 1035.3)

B. A trainee must train in a program approved for this purpose by the Department.

(BPC § 1205)

C. A trainee must work under the direct and responsible supervision of the

laboratory director or a person other than a trainee licensed under BPC chapter

3. (BPC § 1205)

D. The ratio of licensed persons to trainees must not exceed two licensed persons

to one trainee. (17 CCR § 1035 (d))

VIII. APPLICATION OF CLINICAL LABORATORY LAW

A. California law is broadly applied to include all facilities providing analyses of all

human body specimens including blood, urine, feces, hair, breath, saliva, and

body fluids. (BPC § 1206)

B. A laboratory located outside California performing tests on specimens originating

in California must be licensed or registered by the Department. (BPC § 1241)

C. Exempt from California laboratory law are laboratories owned by the US

government, public health laboratories, forensic laboratories, research and

teaching laboratories, SAMSHA laboratories, childcare centers performing

glucose testing on diabetic children, persons performing over-the-counter

purchased home test kits, and emergency medical technicians and paramedics

en route to a hospital performing glucose testing. (BPC § 1241(b))

D. A separate license is not needed for mobile laboratories, not-for-profit or

government laboratories performing fewer than 15 moderately complex or waived

tests, laboratories within a hospital operating under a single license, or

laboratories at a single address operating under common ownership. (BPC §

1265 (d))

E. Laboratory licenses and personnel licenses must be posted in plain view in the

laboratory. (BPC § 1266)

F. A laboratory must notify the Department of Consumer Affairs when a specimen

storage box has been improperly secured. (BPC § 1220.5)

G. A laboratory or a person licensed, registered, or certified by the Department

under Chapter 3 of the BPC must notify the Department within 30 days of any

change of name or address. (BPC § 1227)

H. A laboratory must report infectious diseases to the appropriate county health

officer. (17 CCR § 2505)

I. A laboratory must keep all records for three years, cytology records for five

years, and cytology reports and histopathology reports for ten years. (BPC §§

1265(j)(2)(A) and 1271)

J. All clinical laboratory results must be reviewed and released by authorized

persons (BPC §§ 1206.5 and 1269(d)), except those released by autoverification

using a computer algorithm in conjunction with automated clinical laboratory

instrumentation (BPC § 1209.5), to the healthcare provider who ordered the

tests. (BPC § 1288)

K. A patient may request from his or her physician to receive test results by internet

or other electronic means. (Health and Safety Code (HSC) § 123148)

L. A laboratory may accept self-ordered tests only for tests that are approved by the

FDA for over-the-counter purchase for home testing. (BPC § 1246.5)

M. A report of results from a clinical laboratory must show clearly the name and

address of the laboratory and the name of the laboratory director. (BPC § 1288)

N. Blood banks (HSC § 1600.2) and tissue banks (HSC § 1635) must be licensed

separately from clinical laboratories. (HSC § 1635.1)

O. A laboratory does not need proof of written consent to perform HIV screening

tests. (HSC § 120990)

IX. PROFICIENCY TESTING

A. A laboratory must authorize its PT provider to release results to the Department

in an electronic format compatible with the State's monitoring system. (BPC §

1220(a)(1)(B) and 17 CCR § 1066(d)(2))

B. A laboratory must enroll with a State-approved PT provider. (BPC § 1272)

C. A Laboratory must follow all CLIA PT requirements. (BPC § 1220)

D. A laboratory license is subject to revocation for referring PT to another

laboratory. (17 CCR § 1065.45)

X. CYTOLOGY

A. A laboratory performing cytology must be licensed by the Department. (BPC §

1265)

B. A cytotechnologist cannot perform more than 80 manual Pap smears or 100

automated or semi-automated Pap smears in a 24-hour period. If the

cytotechnologist has other duties, these limits must be reduced appropriately.

(BPC § 1271)

C. A licensed cytotechnologist may perform all tests and procedures pertaining to

cytology, including, but not limited to, microscopic and nonmicroscopic

methodologies and tests and procedures that utilize molecular or genetic

methodologies, that are performed on cytologic specimens related to infectious

disease or cancer diagnosis, under the overall operation and administration of a

laboratory director, who shall be a qualified pathologist. (BPC § 1270)

D. Any tests or procedures performed by a licensed cytotechnologist must be

performed in a licensed clinical laboratory certified in the subspecialty of

diagnostic cytology. (BPC § 1270)

E. A cytotechnologist must record the number of cases performed each day at each

location where he or she works, and the location where the work was performed

must be identified in the report. (BPC § 1271)

F. Ten percent of all normal and all abnormal cytology cases must be reviewed by a

pathologist or supervising cytotechnologist. (BPC § 1271)

G. A cytology laboratory must send quarterly reports of all dysplasia to doctors

submitting cytologic samples and review previous normal slides of the affected

patients. (BPC § 1274)

H. Anyone who reviews or who performs testing on a cytology case must sign the

worksheet or report, even if he or she disagrees with the final report. (42 CFR §

1274(e) and § 493.1283(a))

XI. IT IS UNLAWFUL UNDER CALIFORNIA LAW TO:

A. Pose as a licensed person when not licensed. (BPC § 1280)

B. Operate a laboratory without a license, registration, or certificate of deemed

status issued by a State-approved accrediting organization. (BPC § 1281)

C. Buy or sell blood for diagnostic purposes. (BPC § 1281.1)

D. Engage in clinical laboratory practice unless licensed as a physician, licensed by

the Department, or otherwise authorized. (BPC § 1282)

E. Perform phlebotomy unless authorized. (BPC § 1282.2)

F. Adversely impact the integrity of a specimen. (BPC § 1282.3)

G. Serve as a "nominal" laboratory director. (BPC § 1284)

H. Perform clinical laboratory tests or examinations unless licensed or authorized.

(BPC § 1285)

I. Perform tests or examinations outside the scope of the laboratory’s approval or

outside the specialty of the testing person’s authorization. (BPC § 1288.5)

J. Operate a school or conduct a training program for clinical laboratory personnel

without State approval. (BPC § 1286)

K. Accept a test without a physician referral. (BPC § 1288)