Untitled California Attorney General Opinion

TO BE PUBLISHED IN THE OFFICIAL REPORTS
OFFICE OF THE ATTORNEY GENERAL
State of California
JOHN K. VAN DE KAMP
Attorney General
_________________________
:
OPINION : No. 86-302
:
of : JANUARY 28, 1987
:
JOHN K. VAN DE KAMP :
Attorney General :
:
JACK R. WINKLER :
Deputy Attorney General :
:
________________________________________________________________________
THE HONORABLE JOHAN KLEHS, MEMBER OF THE CALIFORNIA
ASSEMBLY, has requested an opinion on the following question:
May a registered nurse not licensed under the Clinical Laboratory Law
lawfully perform a clinitest, acetest, a blood glucose dipstick test, a hematest or
hemoccult, or a urine dipstick test in a hospital ward or a medical clinic?
CONCLUSION
When authorized by order of a physician or a standardized procedure a
registered nurse not licensed under the Clinical Laboratory Law may lawfully perform a
clinitest, acetest, a blood glucose dipstick test, a hematest or hemoccult, or a urine
dipstick test in a hospital ward or a medical clinic.
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ANALYSIS
We are advised that in some hospitals and clinics registered nurses
routinely perform certain tests on specimens taken from patients. These tests include the
clinitest, acetest, the blood glucose dipstick test, the hematest and hemoccult, and the
urine dipstick test.1 These tests utilize kits manufactured for each particular test which
include a test strip, tablet or solution containing the requisite reagents and a color chart
calibrated to give the test results. The specimen is combined with the test strip or
solution which produces a color change and the test results are read from the matching
color on the color chart. These kit tests may be performed quickly, in close proximity to
the patient and without the use of any additional equipment or apparatus.
We are asked whether a registered nurse may perform such kit tests in a
hospital ward or a medical clinic. We assume that such tests will be performed on a
specimen taken from a patient of a physician in connection with his or her treatment of
the patient.
In determining whether a registered nurse may lawfully perform such tests
we examine first the authority granted to registered nurses by the Nursing Practice Act
(Business and Professions Code section 2700 et seq., the "NPA") and then examine the
1
The clinitest (reagent strip) and acetest (tablet) are used to monitor urine glucose in
screenings for diabetes. On contact with a specimen a color change occurs from which an
estimate of urine glucose and ketone levels may be made by comparing the test color with a
standardized color chart that is supplied with the strips or tablets. (See Physicians' Desk
Reference (38th ed. 1984) ("PDR") at pp. 3004, 3008, and 3012.)
Reagent strips also permit a quick determination to be made of the approximate blood
glucose levels in patients with diabetes. A patch of reagents in a hand-held plastic strip reacts
with a capillary blood sample (finger stick) causing a color change which is compared with a
standardized color chart providing semi-quantitative readings of blood glucose levels. (See
PDR, supra, at pp. 3005, 3008.)
The hematest and hemoccult are tests for detecting the presence of blood in the feces due
to hidden gastrointestinal bleeding. The hematest (reagent tablet) and hemoccult (guaiac filter
paper) produce a blue reaction in a fecal smear if a specified amount of blood is present. (See
PDR, supra, at pp. 3005, 3008, 3016-3017.)
Urine dipsticks are used to test the pH (acidity or alkalinity) of urine or gastric drainage
by dipping the reagent strip into a fresh specimen and comparing the resultant color change with
a color chart supplied with the test strips. (See PDR, supra, at p. 3004.)
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Clinical Laboratory Law (§ 1200 et seq., the "CLL") for any provisions which might
regulate such testing.
Section 27252 in the NPA provides in part:
". . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
"The practice of nursing within the meaning of this chapter means
those functions, including basic health care, which help people cope with
difficulties in daily living which are associated with their actual or potential
health or illness problems or the treatment thereof which require a
substantial amount of scientific knowledge or technical skill, and includes
all the following:
"(a) Direct and indirect patient care services that insure the safety,
comfort, personal hygiene, and protection of patients; and the performance
of disease prevention and restorative measures.
"(b) Direct and indirect patient care services, including, but not
limited to, the administration of medications and therapeutic agents,
necessary to implement a treatment, disease prevention, or rehabilitative
regimen ordered by and within the scope of licensure of a physician,
dentist, podiatrist, or clinical psychologist, as defined by Section 1316.5 of
the Health and Safety Code.
"(c) The performance of skin tests, immunization techniques, and the
withdrawal of human blood from veins and arteries.
"(d) Observation of signs and symptoms of illness, reactions to
treatment, general behavior, or general physical condition, and (1)
determination of whether such signs, symptoms, reactions, behavior, or;
general appearance exhibit abnormal characteristics; and (2)
implementation, based on observed abnormalities, of appropriate reporting,
or referral, or standardized procedures, or changes in treatment regimen in
accordance with standardized procedures, or the initiation of emergency
procedures. . . .
The rest of the section defines "standardized procedures."
2
Section references are to the Business and Professions Code unless otherwise indicated.
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In 67 Ops.Cal.Atty.Gen. 122, 137 we construed the basic definition of the
practice of nursing (the first quoted of § 2725, above) to include only those functions
which are like those specifically enumerated in subdivisions (a), (b), (c), and (d). We
therefore examine those subdivisions for authority to perform the tests in question.
Subdivision (b) of section 2725 authorizes a registered nurse to provide
"patient care services . . . necessary to implement a treatment . . . regimen ordered by . . .
a physician . . . ." The "patient care services" referred to include but are not limited to the
administration of medications. We believe that these services include performing one of
the tests in question upon a specimen taken from a patient when such testing is ordered
by the patient's physician as part of a treatment, disease prevention, or rehabilitative
regimen.3
Subdivision (d) authorizes registered nurses to make observations of signs
and symptoms of illness and reactions to treatment and determine if they are abnormal
and based on the observed abnormalities to implement certain procedures in accordance
with standardized procedures. We believe that such standardized procedures might well
incorporate one or more of the tests in question to assist the nurse to make the
observations referred to or to assist in the determination whether they are abnormal.
Subdivision (c) specifically authorizes a registered nurse to perform skin
tests among other procedures. It has been suggested that by expressly authorizing the
performance of skin tests the Legislature impliedly disqualified registered nurses from
performing other kinds of tests. We reject this suggestion because by using the word
"includes" to introduce the four subdivisions specifying certain nursing functions the
Legislature indicated that the functions specified are not exclusive. (See 67
Ops.Cal.Atty.Gen. 122, 136.)
We conclude that the Nursing Practice Act does provide statutory authority
for a registered nurse to perform the tests in question pursuant to the order of a physician
to implement a treatment, disease prevention or rehabilitative regimen for a patient or
when authorized by a standardized procedure adopted pursuant to subdivision (d) of
section 2725.
3
We are advised that one use of these tests is to monitor a diabetic patient's need for
insulin. The physician may give a standing order to the nursing staff to administer insulin to the
patient whenever the patient's blood glucose level reaches a stated level and directs the nurses to
perform periodic tests for blood glucose level utilizing an appropriate test kit to determine when
the level is reached calling for an insulin shot.
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Turning to the Clinical Laboratory Law we note that unlike other practice
acts in the medical arts field the act does not undertake to define the practice being
regulated. Instead the CLL in section 1206 defines a "clinical laboratory" as "any place,
establishment, or institution organized and operated for the practical application of one or
more of the fundamental sciences by the use of specialized apparatus, equipment, and
methods for the purpose of obtaining scientific data which may be used as an aid to
ascertain the presence, progress, and source of disease in human beings." The CLL then
requires licensing of all clinical laboratories with certain exceptions. (See § 1241.)
Licensure is also required of all those who work in clinical laboratories with certain
exceptions. (See § 1260 et seq.)
Section 1282 of the CLL provides:
"It is unlawful for any person to make any test or examination in a
clinical laboratory unless he is a duly licensed physician and surgeon or is
duly authorized to do so under the provisions of this chapter." (Emphasis
added.)
The words "test or examination" are not defined in the statute. Section 1240 provides in
part that the CLL "does not prohibit the performance of tests not covered in Section
1206." Thus the statutory scheme contemplates that not all testing is governed by the
CLL.
Section 1220 of the CLL provides that the department (defined in § 1202 to
mean the State Department of Health Services) "shall by regulation require that all
licensed clinical laboratories maintain records, equipment, and facilities which are
adequate and appropriate for the services rendered and demonstrate satisfactory
performance in a proficiency testing program approved by the department." The
department regulations (tit. 17, Cal. Admin. Code, § 1053) define "clinical laboratory
test" and "clinical laboratory specimen" as follows:
"(a) A "Clinical laboratory specimen" means any material removed
from a human being on which examinations can be made to aid in
ascertaining the presence, progress, or source of disease in human beings.
"(b) Pursuant to the provisions of Sections 1206 and 1240 of the
Business and Professions Code a "clinical laboratory test" means a
procedure which is performed in a clinical laboratory and employs the
principles of one or more of the fundamental sciences to detect, identify,
measure or enumerate any particular entity or substance in a clinical
laboratory specimen." (Emphasis added.)
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Both section 1206 and the department regulations expressly restrict the application
of the CLL to the "clinical laboratory". Thus if a procedure takes place outside a clinical
laboratory the CLL does not regulate it.
The next problem is to determine the meaning of clinical laboratory under the
CLL. We start by repeating the statutory definition set forth in section 1206:
"As used in this chapter, 'clinical laboratory' means any place,
establishment, or institution organized and operated for the practical
application of one or more of the fundamental sciences by the use of
specialized apparatus, equipment, and methods for the purpose of obtaining
scientific data which may be used as an aid to ascertain the presence,
progress, and source of disease in human beings."
The "place, establishment or institution" language is somewhat vague in defining the
perimeter of a clinical laboratory. If a place, establishment or institution is organized and
operated solely to make laboratory tests on human specimens the entire facility is a
clinical facility under section 1206. A hospital can also be described as a "place,
establishment or institution" but it is not organized and operated to make laboratory tests
on human specimens. This may be one of its many functions as where a clinical
laboratory is established and operated within the hospital. But this fact does not make the
entire hospital a clinical laboratory any more than the fact that a separate independent
laboratory serves several hospitals and doctor's offices makes those hospitals and doctor's
offices clinical laboratories. The statutory definition confines a clinical laboratory to the
place where there is a "practical application of one or more of the fundamental sciences
by use of specialized apparatus, equipment and methods for purposes of obtaining
scientific data which may be used as an aid to ascertain the presence, progress, and
source of disease in human beings." This language contemplates that a clinical laboratory
will have specialized apparatus and equipment and that methods involving the practical
application of one or more of the fundamental sciences utilizing such apparatus and
equipment will be used to obtain certain scientific data useful in diagnosing and treating
human diseases. We will refer to these methods as "laboratory testing."
Section 1220 of the CLL contemplates that a clinical laboratory is to have
certain attributes in addition to those specified in section 1206. Section 1220 provides:
"The department shall by regulation require that all licensed clinical
laboratories maintain records, equipment, and facilities which are adequate
and appropriate for the services rendered and demonstrate satisfactory
performance in a proficiency testing program approved by the department.
In addition, the department shall by regulation require that all licensed
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clinical laboratories be conducted, maintained, and operated without injury
to the public health."
The department has adopted regulations pursuant to section 1220 which are set forth in
title 17, California Administrative Code, section 1050. Subdivision (d) of these
regulations provides that there must be adequate space to conduct and control all tests
performed in the laboratory. Subdivision (e) states that the laboratory must provide for
and assure that equipment, instruments, glassware, and reagents are maintained in proper
working order by periodic inspection, testing or calibration. Subdivision (c) requires that
some person be responsible for directing the operations of the clinical laboratory.
Subdivision (f) requires that a clinical laboratory must maintain records of specimens
received and tested, records of inspections, and written descriptions of each procedure
used. Thus the CLL and the implementing regulations confine a clinical laboratory to a
place which has specified attributes in which laboratory testing on human specimens is
done.
Section 1288 in the CLL provides in part that "[a]ny person conducting or
operating a clinical laboratory may accept assignments for tests only from and make
reports only to persons licensed under the provisions of law relating to the healing arts or
their representatives." Subdivision (f) of the regulations (tit. 17, Cal. Admin. Code,
§ 1050) requires a clinical laboratory to maintain records of specimens received and
tested, including identification of the patient, name of the submitter, dates of receipt and
report, type of test performed, and test results. Subdivision (h) of the regulations provides
that clinical laboratory test results shall not be reported from the laboratory until these
results have been critically reviewed and verified for accuracy, reliability, and validity by
a physician or a person, other than a trainee, licensed under the CLL. Thus the CLL
contemplates that physicians will have specimens taken from their patients, send the
specimens to a clinical laboratory and receive reports back of the test results.
A physician may have reasons to have an immediate test made on a
specimen taken from his or her patient rather than send the specimen out to a clinical
laboratory. The most obvious reason is speed. It may take too long to send the specimen
to a clinical laboratory and await the report of test results to be useful. A faster (though
perhaps less accurate) test may better suit the patient's needs. Another reason may be
cost. A bedside test without the packaging, labeling, transport, review and report writing
required in laboratory testing may well be less costly.
When the applicability of the CLL to the tests in question is considered
several questions arise. Is a hospital ward or medical clinic a clinical laboratory within
the meaning of the CLL? Are the kit tests in question the kinds of procedures the CLL
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was intended to regulate? Does the CLL limit the authority granted to registered nurses
by the NPA? These questions will be considered in turn.
We are asked whether a registered nurse may lawfully perform certain kit
tests in a hospital ward or medical clinic. We have seen that the CLL governs only those
procedures which take place "in a clinical laboratory." We reject the suggestion that any
place where the testing of human specimens to aid in ascertaining the presence, progress
or source of disease occurs is a clinical laboratory under the CLL because such an
interpretation is at odds with the definition and attributes of a clinical laboratory as
contemplated in the statute and its implementing regulations. Ordinarily a hospital ward
or medical clinic does not contain or have the attributes of a clinical laboratory. They do
not have the laboratory equipment and apparatus, reagents and glassware needed to make
many tests, nor is the requisite equipment and procedure testing and record keeping done
there. Conceivably a clinical laboratory with the requisite equipment, staffing, record
keeping and licensure could be set up in a hospital ward or medical clinic4 but we do not
think that is what was contemplated by the question. We conclude that the ordinary
hospital ward and medical clinic is not a clinical laboratory within the meaning of the
CLL.
As previously noted the tests in question all utilize a kit manufactured to
provide all the materials necessary to perform and evaluate a particular test. No other
equipment or apparatus of the kind found in a clinical laboratory is needed. It is not
necessary to take the specimen to another place for testing and obtain a report of the
results. The tests in questions may be performed at the bedside of the patient with results
immediately available to those administering to the patient's medical needs. While the
materials provided in the test kits are the product of a practical application of one or more
of the fundamental sciences, such practical application is accomplished by the kit
manufacturer not by the person performing the test. A detailed knowledge of biology and
chemistry is needed to select and create the special reagent tablet, liquid, or impregnated
dipstick which will produce the particular chemical reaction needed to produce the color
change or other indication to detect and/or measure the questioned substance in a
4
If a clinical laboratory is established in a hospital ward or a medical clinic may a
registered nurse perform the subject tests therein? This question requires an examination of the
purpose for which the nurse makes the test. If the nurse is employed to perform any part of the
laboratory testing which occurs in such clinical laboratory then he or she must have the licenses
required for such functions by the CLL. However, if the nurse's performance of the test in
question is not part of any laboratory testing as contemplated in section 1206 (e.g., the nurse is
carrying out a physician's order to make such test as part of a patient's treatment regimen), the
fact that the test is done in the clinical laboratory would not subject the nurse to the licensing
requirements of the CLL.
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specimen. However, neither laboratory apparatus nor expertise in analysis is necessary to
perform the kit test in question. All of the chemistry and the expertise to make the test
work have been built into the test kit. A nurse performing one of these kit tests need not
be versed in the biochemical detail and scientific basis of the test any more than a person
using a Polaroid camera needs to be versed in the intricacies of photography and film
developing in order to take and have instant photographs. Technology has provided the
means to perform certain tests on human specimens without resort to a clinical
laboratory. Thus we believe that the kit tests in question are not the kinds of procedures
which the Legislature intended to regulate in the CLL.
Section 1240 provides in part that the CLL "does not repeal or in any
manner affect any provision of this code relating to the practice of medicine." The tests
referred to in the question are made in a hospital ward or medical clinic. We have
assumed they are performed on specimens taken from patients as an aid in the treatment
of the patient by the patient's physician. Under such circumstances the performance of
such tests would be part of the treatment of the patient by the physician and thus part of
the physician's practice of medicine. Under the express language of section 1240 the
CLL does not in any manner affect provisions of the code relating to the practice of
medicine.
For these reasons we conclude that a registered nurse not licensed under the
CLL may lawfully perform a clinitest, acetest, a blood glucose dipstick test, a hematest or
hemoccult or a urine dipstick test in a hospital ward or a medical clinic when ordered by
a physician or authorized by a standardized procedure.
*****
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