BILL ANALYSIS Ó
AB 1774
Page 1
Date of Hearing: April 19, 2016
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Rudy Salas, Chair
AB 1774
(Bonilla) - As Introduced February 3, 2016
SUBJECT: Clinical laboratories: licensure.
SUMMARY: Repeals the laws requiring a clinical laboratory to be
licensed and inspected by the California Department of Public
Health (CDPH), including the licensing fees associated with
licensure of clinical laboratories; provides that clinical
laboratories in this state are still subject to the federal
Clinical Laboratory Improvement Amendments of 1988 (CLIA),
including the fees and enforcement policies set forth by CLIA.
EXISTING STATE LAW:
1)Provides for the licensure, registration, and regulation of
clinical laboratories and various clinical laboratory
personnel by the CDPH and authorizes the CDPH to inspect
clinical laboratories and assesses a fee for licensure of
those facilities. (Business and Professions Code (BPC) Section
1200, et seq.)
2)Defines several terms, among others, for the purposes of
governing clinical laboratories: (BPC Section
1206(a)(5)-1206(a)(16))
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a) "Clinical laboratory test or examination" means the
detection, identification, measurement, evaluation,
correlation, monitoring, and reporting of any particular
analyte, entity, or substance within a biological specimen
for the purpose of obtaining scientific data that may be
used as an aid to ascertain the presence, progress, and
source of a disease or physiological condition in a human
being, or used as an aid in the prevention, prognosis,
monitoring, or treatment of a physiological or pathological
condition in a human being, or for the performance of
nondiagnostic tests for assessing the health of an
individual.
b) "Clinical laboratory science" means any of the sciences
or scientific disciplines used to perform a clinical
laboratory test or examination.
c) "Clinical laboratory practice" means the application of
clinical laboratory sciences or the use of any means that
applies the clinical laboratory sciences within or outside
of a licensed or registered clinical laboratory. Clinical
laboratory practice includes consultation, advisory, and
other activities inherent to the profession.
d) "Clinical laboratory" means a place used, or an
establishment or institution organized or operated, for the
performance of clinical laboratory tests or examinations or
the practical application of the clinical laboratory
sciences. That application may include any means that
applies the clinical laboratory sciences.
e) "Direct and constant supervision" means personal
observation and critical evaluation of the activity of
unlicensed laboratory personnel by a physician and surgeon,
or by a person licensed under this chapter other than a
trainee, during the entire time that the unlicensed
laboratory personnel are engaged in the duties, as
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specified.
f) "Direct and responsible supervision" means both of the
following:
i) Personal observation and critical evaluation of the
activity of a trainee by a physician and surgeon, or by a
person licensed under this chapter other than a trainee,
during the entire time that the trainee is performing
clinical laboratory tests or examinations.
ii) Personal review by the physician and surgeon or the
licensed person of all results of clinical laboratory
testing or examination performed by the trainee for
accuracy, reliability, and validity before the results
are reported from the laboratory.
g) "Licensed laboratory" means a clinical laboratory
licensed, as specified, pursuant to state law.
h) "Location" means either a street and city address, or a
site or place within a street and city address, where any
of the clinical laboratory sciences or scientific
disciplines are practiced or applied, or where clinical
laboratory tests or examinations are performed.
i) "Physician office laboratory" means a clinical
laboratory that is licensed pursuant to state law and is
either: (A) a clinical laboratory that is owned and
operated by a partnership or professional corporation that
performs clinical laboratory tests or examinations only for
patients of five or fewer physicians and surgeons or
podiatrists who are shareholders, partners, or employees of
the partnership or professional corporation that owns and
operates the clinical laboratory; or (B) a clinical
laboratory that is owned and operated by an individual
licensed physician and surgeon or a podiatrist, and that
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performs clinical laboratory tests or examinations only for
patients of the physician and surgeon or podiatrist who
owns and operates the clinical laboratory.
j) "Point-of-care laboratory testing device" means a
portable laboratory testing instrument that is used within
the proximity of the patient for whom the test or
examination is being conducted; is used in accordance with
the patient test management system, the quality control
program, and the comprehensive quality assurance program
established and maintained by the laboratory, as specified;
it performs clinical laboratory tests or examinations
classified as waived or of moderate complexity under the
federal CLIA; performs clinical laboratory tests or
examinations on biological specimens that require no
preparation after collection; or, provides clinical
laboratory tests or examination results without calculation
or discretionary intervention by the testing personnel;
performs clinical laboratory tests or examinations without
the necessity for testing personnel to perform calibration
or maintenance, except resetting pursuant to the
manufacturer's instructions or basic cleaning.
aa) "Public health laboratory" means a laboratory that is
operated by a city or county, as specified.
bb) "Registered laboratory" means a clinical laboratory
pursuant to BPC Section 1265(a)(2).
3)Specifies that a person licensed to provide health care
services under the laws of this state, as specified, is not
prohibited from practicing the profession or occupation for
which he or she is licensed, nor does it authorize a person
licensed under the laws of this state to perform or order
services for which he or she is not licensed to perform or
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order. (BPC Section 1206)
4)Exempts specified pharmacy clinical laboratory settings from
inspection by CDPH if the laboratory only performs specified
tests classified as waived under CLIA and are approved by the
federal Food and Drug Administration (FDA) for sale to the
public without a prescription in the form of an
over-the-counter test kit, as specified. (BPC Section 1206.6)
5)Defines "unlicensed laboratory personnel" to mean a laboratory
aide, histocompatibility technician, cardiopulmonary
technician, or other person performing the activities
authorized by Section 1269. (BPC Section 1212)
6)Requires each clinical laboratory to maintain records,
equipment, and facilities that are adequate and appropriate
for the services rendered and operated without injury to the
public health; requires the CDPH to inspect laboratories no
less than once every two years if licensed, maintain a record
of those inspections, ensure that every licensed clinical
laboratory in California is inspected at least that often;
provides that registered clinical laboratories shall not be
routinely inspected by CDPH; requires a clinical laboratory to
perform all clinical laboratory tests or examinations
classified as waived under CLIA in conformity with the
manufacturer's instructions; clinical laboratories performing
tests or examinations not waived under CLIA must establish and
maintain a patient test management system, as specified, must
establish and maintain a quality control program, and may use
alternative quality control testing procedures recognized CMS
or an Individualized Quality Control Plan and a comprehensive
quality assurance program, as specified. (BPC Section 1220)
7)Declares that it is the public policy of the state to ensure
that California's laboratory standards, including its
laboratory personnel standards, be sustained in order to
provide accurate, reliable, and necessary test results; that
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inspections are the most effective means of furthering this
policy; that it is not the intent of the Legislature to reduce
in any way the resources available to the department for
inspections, but rather to provide the department with the
greatest flexibility to concentrate its resources where they
can be most effective; that it is the intent of the
Legislature to provide for an inspection process that includes
state-based inspection components and that determines
compliance with federal and state requirements for clinical
laboratories. (BPC Section 1223(a))
8)Authorizes the CDPH to employ, or contract for, inspectors,
special agents, and investigators, and provide any clerical
and technical assistance as necessary to administer this
chapter and may incur other expenses as necessary. (BPC
Section 1223(b))
9)Provides that laboratories accredited by a private, nonprofit
organization shall be deemed by the CDPH to meet state
licensure or registration requirements, and be issued a
certificate of that deemed status by the CDPH, provided that
both the organization and the laboratory meet specified
requirements. (BPC Section 1223(c))
10)Requires every person or clinical laboratory licensed or
registered under California clinical laboratory requirements
to report to the CDPH within 30 days of any change of name or
address. (BPC Section 1227)
11)Requires a clinical laboratory performing clinical laboratory
tests or examinations classified as of moderate or of high
complexity under CLIA to obtain a clinical laboratory license
as specified; provides that no clinical laboratory license
shall be issued by the CDPH unless the clinical laboratory and
its personnel meet the CLIA requirements for laboratories
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performing tests or examinations classified as of moderate or
high complexity, or both; requires a clinical laboratory
performing tests or examinations subject to a certificate of
waiver or a certificate of provider-performed microscopy under
CLIA, to register with the CDPH; provides that a license or
registration is valid for one year unless revoked or
suspended; provides that whenever a clinical laboratory ceases
operations, the laboratory owners, as specified, must notify
the CDPH of this fact, in writing, within 30 calendar days
from the date a clinical laboratory ceases operation and
maintain all medical records and laboratory records, as
defined, for specified timeframes; provides that a separate
license is required for each location except as specified;
provides that the CDPH must state in writing the reason for
denying an applicant for clinical laboratory licensure;
provides that a withdrawal of application for clinical
laboratory licensure does not deprive the CDPH to institute or
continue with a proceeding for denial; and provides that the
suspension, expiration, or forfeiture by operation of law of a
license or registration does not deprive the CDPH's authority
to institute or continue an action against a license or
registration. (BPC Section 1265)
12)Provides that a primary care clinic that submits an
application to the CDPH for a clinic license pursuant to
Health and Safety Code (HSC) 1204(a) may submit before or
along with the clinic application an application for a license
to conduct clinical laboratory tests and examinations, as
specified. (BPC Section 1265.1)
13)Requires a clinical laboratory's license and the license or
renewal permit of each person performing tests to be
conspicuously posted. (BPC Section 1266)
14)Provides that any denial, suspension, or revocation of a
license must be conducted in compliance with HSC Section
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100171. (BPC Section 1267)
15)Requires the CDPH to establish standards for the evaluation
of cytologic slides, reporting of slides, personnel competency
standards and a proficiency testing program for clinical
laboratories offering cytology services. (BPC Section 1272.4)
16)Requires the CDPH to develop or adopt a CDPH-administered
proficiency testing program for laboratories offering cytology
services to be administered by the CDPH or by a proficiency
testing program approved by the CDPH; provides that the
program conduct announced and unannounced onsite proficiency
testing under normal working conditions. (BPC Section 1272.6)
17)Specifies that it is unlawful for a person to own, operate,
maintain, direct, or engage in the business of operating a
clinical laboratory, as defined, unless he or she possess a
valid clinical laboratory license; provides that a health
facility, as specified, is not required to obtain a clinical
laboratory license. (BPC Section 1281)
18)Authorizes the CDPH to establish and charge fees, as
specified, for licensing activities, including: (BPC Section
1300 - 1302)
a) Issuing a duplicate license for a change of name; (BPC
Section 1268)
b) Application for licensure, renewal, and delinquency for
personnel and trainee licenses; (BPC Sections 1260.3,
1270.5,
c) Application for a license to perform moderate or high
complexity tests, as defined under CLIA, based on the
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number of tests performed annually;
d) Renewal of a license to perform moderate or high
complexity tests, as defined under CLIA, based on the
number of tests performed annually;
e) Examinations pursuant to this chapter, as specified;
f) Application for registration to perform tests or
examinations considered waived under CLIA or
provider-performed microscopy;
g) Cost recovery for CDPH to conduct a complaint
investigation, impose sanctions, or conduct a hearing, as
specified; specifies that the amount paid by a laboratory
for these enforcement activities is limited to no more than
the amount a laboratory would pay under CLIA for the same
actions; requires a laboratory applying for initial
licensures to pay for the CDPH to conduct any
re-inspections to ensure compliance;
h) Continuing education; (BPC Section 1275)
i) Cost recovery for an inspector to travel to a clinical
laboratory outside of California to ensure compliance; and,
j) Additional laboratory locations, as specified. (BPC
Section 1300)
19)Provides that the fees specified in BPC Section 1300 are
adjusted annually pursuant to HSC Section 100450. (BPC
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Section 1300.1)
20)Requires the CDPH to give written notice prior to a license
or registration expiring, as specified, and authorizes the
CDPH to require an examination as a condition for
reinstatement if the licenses renewal fee is not paid, as
specified. (BPC Section 1301)
21)Provides that CDPH may revoke or suspend a clinical
laboratory license if the laboratory does not meet the
requirements to operate, as specified; provides that CDPH may
impose directed plans of corrections, as defined under CLIA;
impose civil money penalties in specified amounts for each day
of noncompliance; and impose onsite monitoring, as defined
under CLIA, and recover costs associated with onsite
monitoring. (BPC Section 1310)
EXISTING FEDERAL LAW:
1)Establishes CLIA, which regulates clinical laboratories that
perform tests on human specimens and sets standards for
facility administration, personnel qualifications and quality
control. These standards apply to all laboratory settings,
including commercial, hospital or physician office
laboratories. (Title 42 of the Code of Federal Regulations
(CFR), Part 493)
THIS BILL:
1)Repeals state mandates for CDPH to conduct laboratory
inspections and contract with accreditation organizations.
(BPC Section 1223)
2)Repeals reporting requirements for a licensed clinical
laboratory when the laboratory changes a name or address.
(BPC Section 1227)
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3)Repeals provisions allowing a primary care clinic, or a
network of primary care clinics, as defined, to obtain a
license to operate a clinical laboratory that conducts
moderate to high complexity tests or examinations; repeals
application provisions for these primary care clinics to apply
for licensure. (BPC Sections 1241.1, 1265.1)
4)Repeals provisions requiring a clinical laboratory performing
moderate or high complexity tests or examinations to be
licensed by CDPH; repeals provisions requiring clinical
laboratories performing tests or examinations considered
waived under CLIA to register with CDPH; repeals provisions
describing the application process, lifetime of a license or
registration, notices required of CDPH as they relate to
licensed clinical laboratories, withdrawal and renewal of a
clinical laboratory license, suspension, expiration, and
forfeiture of a clinical laboratory license; and repeals
requirements for a licensed clinical laboratory to maintain
medical and laboratory records, as specified. Repeals
provisions making it unlawful for a person to own, operate,
maintain, direct, or engage in the business of operating a
clinical laboratory, as defined, unless he or she possess a
valid clinical laboratory license. (BPC Section 1265 and 1281)
5)Repeals requirements relating to the display of a clinical
laboratory license and the license or current renewal permit
of each person performing tests. (BPC Section 1266)
6)Repeals requirements for a denial, suspension, or revocation
of a license to be in compliance with HSC Section 100171.
(BPC Section 1267)
7)Repeals fees associated with clinical laboratory licensing or
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registration. (BPC Sections 1268, 1300(p), and 1300.1)
8)Repeals requirements relating to standards and requirements
for cytology programs, including proficiency testing and
reporting to the CDPH. (BPC Section 1272.4 and 1272.6)
9)Repeals authorization for CDPH to impose, instead of
suspension or revocation of a license, directed plans of
corrections, as defined under CLIA; impose civil money
penalties in specified amounts for each day of noncompliance;
and impose onsite monitoring, as defined under CLIA, and
recover costs associated with onsite monitoring. (BPC Section
1310)
10)Specifies that clinical laboratories must continue to comply
with federal provisions specified in CLIA and must adhere to
quality control plans, inspections, and enforcement policies
set forth by CMS.
11)Makes other conforming, technical, non-substantive changes.
FISCAL EFFECT: Unknown. This bill is marked fiscal by the
Legislative Counsel.
COMMENTS:
Purpose. This bill repeals the laws requiring a clinical
laboratory to be licensed and inspected by the CDPH, including
the licensing fees associated with licensure of clinical
laboratories and provides that clinical laboratories in this
state are still subject to the federal CLIA, including the fees
and enforcement policies set forth by CLIA.
This bill is sponsored by the author. According to the author,
"Laboratory Field Services (LFS) is the state entity responsible
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for licensing clinical laboratories and clinical laboratory
personnel in California. In two successive audits over [eight]
years, the State Auditor has found that LFS is woefully
neglecting its state mandate. Despite past Legislative efforts
to increase its budget, allow for additional staffing, and
reduce workload through a mechanism to contract [with]
accrediting bodies, [LFS] continues to fail to meet the majority
of its mandates. In the Auditor's September 2015 report, she
noted that state and federal law regarding clinical labs is
highly duplicative. In fact, in the mid 1990's, California made
strides to try to become exempt from federal oversight. In this
process, the Legislature passed laws which were purposely
duplicative of federal standards [(SB 113 (Maddy), Chapter 510,
Statutes of 1995)]. However, in 1999, the State decided not to
move forward with the exemption process. This has left us with
a statutory and regulatory structure that largely copies the
federal structure. AB 1774 implements the State Auditor's
recommendation that we repeal state clinical laboratory
licensing because the federal government oversight is highly
similar and also well implemented. AB 1774 will free up state
resources to focus on personnel standards which are unique to
California, while ensuring a continued level of consumer
protection in clinical laboratories."
Background. Clinical laboratories analyze human specimens such
as blood, tissue, and urine so that medical professionals can
make diagnoses, prescribe treatment, and perform research. The
CDPH oversees these laboratories through licensing, proficiency
testing, and inspections by the LFS within the CDPH. Oversight
responsibilities for the LFS cover licensing of personnel, such
as clinical lab scientists and phlebotomists, and in-state
laboratories as well as out-of-state laboratories that test
specimens originating within California. There are
approximately 2,800 licensed laboratories and approximately
19,300 registered labs. A lab's license or registration is
separate from personnel licenses or other certifications.
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The difference between a licensed laboratory and a registered
laboratory is determined by the complexity of the tests
performed by the lab. A laboratory must be licensed to perform
tests of moderate to high complexity, such as testing for
hepatitis or certain sexually transmitted diseases by DNA probe,
but is authorized to perform all tests. Registered laboratories
may perform waived tests, which are simple tests with less
chance of error or risk, such as prepackaged manufactured tests.
A license or registration is valid for one year and must be
renewed annually for the laboratory to continue operating.
Additionally, laboratories must pay a set licensing or
registration fee determined by the volume and type of tests
performed. Licensed laboratories must be inspected by the LFS
every two years and be notified of any deficiencies revealed by
an inspection. Registered laboratories need not be inspected
every two years, but may be inspected as part of a complaint
investigation.
The state has overseen laboratories since 1926 and has licensed
laboratories since the 1950s. In addition to meeting state
requirements, all laboratories that the LFS licenses or
registers must adhere to federal regulations outlined in the
CLIA which was enacted to ensure the accuracy and reliability of
laboratory testing. The federal Centers for Medicare and
Medicaid Services (CMS) has primary responsibility under the
CLIA to regulate laboratories across the nation.
The CLIA groups laboratories into two categories based on the
complexity of the tests performed. Laboratories that perform
complex tests are subject to ongoing oversight in the form of
biennial inspections and proficiency testing. At the federal
level, these laboratories can choose to be overseen by the CMS
or by an accreditation organization that is approved by the CMS.
Laboratories that perform waived tests are overseen by the CMS.
Inspections by Accreditation Organizations. The federal
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government contracts with the LFS or with CMS-approved
accredited organizations to carry out its inspection mandate.
Pursuant to a recommendation by the State Auditor in 2008, the
LFS began using a state checklist addendum while conducting the
federal CLIA inspections, which would incorporate additional
state laws into the CLIA inspection and qualify the one
inspection for both the CLIA and state requirements. According
to the Auditor, the state checklist includes 15 criteria, most
of which relate to personnel standards.
Approved accredited organizations are national accrediting
organizations that the CMS has vetted and determined to possess
high standards and quality when conducting its accreditation
process. Accreditation by one of these organizations meets the
federal CLIA inspection requirements.
Although the LFS has been accepting applications since January
1, 2011, only one organization has been approved, two have been
pending for the last five years, and one was withdrawn. The LFS
is required to approve (or deny) an application within six
months; however, the first application was under review for
almost two years. The organization was approved in August 2013,
but the LFS still has not entered into an agreement to specify
its role and responsibilities.
The LFS inspects less than 20% of the laboratories that the LFS
has not contracted with the federal government to inspect. In
the Northern California LFS office, one staff person is assigned
to inspect all 250 Northern California labs; however, only eight
inspections were conducted in 2013-2014. In Southern
California, only 195 of 600 laboratories were inspected in the
same timeframe.
Exemption to Federal Oversight. A state can request to be
exempted from all or part of CLIA's requirements in order to
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retain full oversight over the laboratories within its
jurisdiction. Senate Bill 113 (Maddy), Chapter 510, Statutes of
1995 made several changes to state law to incorporate CLIA
standards and facilitate a CLIA exemption. California earned
the CLIA exemption in 1999 but declined to pursue it because of
concerns regarding an annual $2.4 million overhead fee paid to
the federal Department of Health and Human Services. As a
result, the state has been operating under a largely duplicative
set of state and federal standards.
In order to be exempted, the state must establish standards that
are equal to or more stringent than federal CLIA. CDPH has
highlighted some of the major differences between the CLIA law
and California law shown in the chart below:
----------------------------------------------------------------
|Subject |CLIA law |California law |
|Matter | | |
|--------+---------------------------+---------------------------|
|Laborato|Requires all laboratories |Requires all laboratories |
|ry |to have a qualified |to have a director who is |
|Director|director who is a state |qualified as a California |
|s |licensed physician and |licensed physician and |
| |surgeon, bioanalyst, or |surgeon, clinical |
| |doctoral scientist (not |laboratory bioanalyst, or |
| |limited by specific |doctoral scientist in |
| |specialty areas). |specific specialty areas. |
|--------+---------------------------+---------------------------|
| |Allows only one person to |Allows multiple directors. |
| |serve as director. | |
|--------+---------------------------+---------------------------|
| |Does not require a |Requires a pathologist |
| |qualified pathologist to |director for acute care |
| |direct a hospital |hospitals. |
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| |laboratory. | |
|--------+---------------------------+---------------------------|
| |Does not mandate any |Requires a laboratory |
| |requirements for an |director for a waived |
| |individual in charge of a |laboratory. |
| |waived laboratory. | |
|--------+---------------------------+---------------------------|
| |Requires notification to |Requires appointment of an |
| |CMS within 30 days of |interim laboratory |
| |change of director. |director within 5 days of |
| | |major change and |
| | |notification to CDPH |
| | |within 30 days. |
|--------+---------------------------+---------------------------|
|Laborato|Does not require licensure |Requires laboratory |
|ry |for laboratory supervisors |supervisors to pass an |
|Supervis|but requires that |examination and have |
|ors |supervisors possess a |licensure by state. |
| |current state license if | |
| |state licensure is | |
| |required. | |
|--------+---------------------------+---------------------------|
|Clinical|Does not have category of |Recognizes a waived |
| |technical consultant for |laboratory technical |
|Consulta|waived tests. |consultant for waived |
|nt | |tests. |
|--------+---------------------------+---------------------------|
| |Requires clinical |Requires clinical |
| |consultant to meet |consultant to be licensed |
| |qualifications but they do |to direct a clinical |
| |not require licensure, but |laboratory or have |
| |requires that consultants |California licensure as a |
| |possess a current state |physician and surgeon. |
| |license if state licensure | |
| |is required. | |
|--------+---------------------------+---------------------------|
|Testing |Does not specify education |Specifies education |
|Personne|requirements other than a |requirements including |
|l |minimum of an associate |courses and credit hours: |
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| |degree for high |baccalaureate degree, |
| |complexity, and high |except for US military |
| |school graduation for |training and experience, |
| |moderate and waived |for high complexity; |
| |testing. |associate degree for |
| | |moderate and waived. |
|--------+---------------------------+---------------------------|
| |Does not require licensure |Requires licensure for |
| |for testing personnel but |testing personnel. |
| |requires that testing | |
| |personnel possess a | |
| |current state license if | |
| |state licensure is | |
| |required. | |
|--------+---------------------------+---------------------------|
| |Does not require |Requires CE for renewal of |
| |continuing education (CE). |license. |
|--------+---------------------------+---------------------------|
|Cytology|Does not require licensure |Requires licensure of |
| |of cytotechnologists. |cytotechnologists. |
|--------+---------------------------+---------------------------|
| |Limits a cytotechnologist |Limits a cytotechnologist |
| |to reading 100 Pap slides |to reading 80 Pap slides |
| |per day, or perform 200 |per day, or perform 160 |
| |automated screenings. |automated screenings, less |
| | |if adjusted for other |
| | |duties. |
|--------+---------------------------+---------------------------|
| |N/A |Requires a |
| | |cytotechnologist to record |
| | |the number of Pap slides |
| | |read each day at all |
| | |locations at which they |
| | |work. |
|--------+---------------------------+---------------------------|
| |Requires an authorized |Requires a licensed person |
| |testing person to sign all |to review and release all |
| |results. |results. |
|--------+---------------------------+---------------------------|
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|Phleboto|Does not address issues of |Explains who may perform |
|my |phlebotomy. |phlebotomy and under what |
| | |conditions, and sets |
| | |requirements of education |
| | |and training to be |
| | |certified by CDPH to |
| | |collect blood for testing. |
|--------+---------------------------+---------------------------|
| | |Requires approval of |
| | |phlebotomy training |
| | |programs by CDPH. |
|--------+---------------------------+---------------------------|
|Unlicens|Does not have category of |Requires documentation of |
|ed |laboratory aide. |competence of unlicensed |
|Personne| |laboratory aides, limits |
|l as | |their activities, and |
|Laborato| |specifies supervision |
|ry | |requirements. |
|Aides | | |
|--------+---------------------------+---------------------------|
|Personne|Does not inspect for or |Checks compliance with |
|l |enforce state personnel |state personnel |
|Licensur|requirements; if personnel |requirements, and |
|e |violations are found, they |sanctions or penalizes for |
|Enforcem|are referred to state |violations. |
|ent |program. | |
|--------+---------------------------+---------------------------|
|Laborato|Does not define ownership |Defines who can own and |
|ry |or set qualifications for |operate a laboratory, |
|Owners |ownership. |requires ownership |
| | |disclosure down to 5% |
| | |interest. |
|--------+---------------------------+---------------------------|
| | |Tracks change of ownership |
| | |and requires notification |
| | |of CDPH within 30 days. |
|--------+---------------------------+---------------------------|
| | |Holds owner and director |
| | |jointly and severally |
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| | |responsible for actions of |
| | |the lab. |
|--------+---------------------------+---------------------------|
|Physicia|Defines POL as a |Closely defines POL and |
|n |self-designated status. |allows up to 5 doctors to |
|Office |Does not specify limits to |oversee a POL to test on |
|Laborato|number of physicians or |their own patients. More |
|ries |receipt of referral |than 5 owners are required |
|(POL) |specimens from outside |to register or be licensed |
| |physicians. |as a laboratory. |
|--------+---------------------------+---------------------------|
|Complain|CLIA does not address |Performs complaint |
|ts |business processes other |investigations of |
| |than Medicare, doesn't |laboratories, offsite |
| |certify or inspect |collection stations, |
| |stand-alone specimen |inducement issues, or |
| |collection sites, and does |personnel issues. |
| |not address inducement | |
| |issues, such as the | |
| |provision of personnel or | |
| |supplies in exchange for | |
| |referrals of laboratory | |
| |work. | |
|--------+---------------------------+---------------------------|
|Reportin|Do not require reporting |Requires laboratories to |
|g of |of infectious diseases as |report infectious diseases |
|Infectio|a condition of licensure. |as a condition of |
|us | |licensure. |
|Diseases| | |
| | | |
|--------+---------------------------+---------------------------|
|Payment |Does not address |Prohibits soliciting, |
|for |fraudulent collection of |selling, or buying blood |
|Blood |blood samples. |or other biological |
|Specimen| |specimens to laboratories, |
|s | |except for research, |
| | |teaching, or quality |
| | |assurance purposes. |
|--------+---------------------------+---------------------------|
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|Autoveri|Does not have a provision |Allows autoverification |
|fication|for autoverification using |using a computer algorithm |
| |a computer algorithm in |in conjunction with |
| |conjunction with automated |automated instrumentation |
| |instrumentation to review |to review and verify the |
| |and verify the results of |results of clinical |
| |clinical laboratory tests |laboratory tests for |
| |for accuracy and |accuracy and reliability. |
| |reliability. |Requires annual review by |
| | |director. |
| | | |
|--------+---------------------------+---------------------------|
|Posting |Does not require posting |Requires personnel |
|of |of personnel licenses in a |laboratory licenses to be |
|Personne|clinical laboratory. |posted in a clinical |
|l | |laboratory. |
|Licenses| | |
| | | |
|--------+---------------------------+---------------------------|
|Certific|Biennial certificate. |Annual license and |
|ate and | |registration renewal. |
|Licensur| | |
|e | | |
|Period | | |
|--------+---------------------------+---------------------------|
|Histopat|Does not require direct |Requires direct |
|hology |supervision of personnel |supervision by a |
| |performing dissection, |pathologist of a person |
| |slide preparation or |engaged in histological |
| |staining of specimens for |dissection when the person |
| |histological examination |assisting a pathologist is |
| |because CLIA does not |not board-certified. |
| |consider these technical | |
| |components to be testing. | |
| | | |
|--------+---------------------------+---------------------------|
|Control |Federal government sets |California controls |
| |rules through regulation |statutes and regulations, |
| |and publication of |with statutory changes |
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| |guidelines. |subject to legislative |
| | |authority and review. |
----------------------------------------------------------------
State Audit Reports. In 2008, the California Bureau of State
Audits published an audit report on the effectiveness of LFS
titled Department of Public Health: Laboratory Field Services'
Lack of Clinical Laboratory Oversight Places the Public at Risk.
The report concluded that the LFS had not provided its state
mandated oversight of labs, struggled to respond to complaints,
and did not have sufficient controls for its policies and
procedures. The LFS attributes these issues to a lack of
funding, but failed to properly increase fees. The report
further detailed missed opportunities for the LFS to leverage
its resources to help meet their state mandated requirements.
The State Auditor recently published its 2015 update report
(Follow-up - California Department of Public Health: Laboratory
Field Services is Unable to Oversee Clinical Laboratories
Effectively, but a Feasible Alternative Exists). The update
concluded that the LFS is still not performing its mandated
oversight requirements. Although the LFS has made progress in
rectifying issues raised in the 2008 report, the LFS continues
to be ineffective in maintaining laboratory oversight.
Additionally, the LFS made an unauthorized fee increase in 2015
that resulted in laboratories overpaying by more than $1
million. Since the 2008 report, the LFS has collected more than
$12 million in laboratory fees that have not been spent.
Despite this surplus, the LFS still faces personnel shortages
and continues to miss inspections, handle complaints and conduct
proficiency testing.
The LFS has also demonstrated problems with its proficiency
testing program, sanctioning program, and complaint inspection.
According to the State Auditor, the LFS has not established
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timeframes for complaint investigation, resolution, or follow
up. The LFS has only sanctioned four facilities since 2007 and
did not collect any civil money penalties during the audit
period. In one case, the LFS took more than 15 months to fine a
laboratory after investigating and confirming use of unlicensed
laboratory personnel. Furthermore, the Auditor found that the
LFS has not inspected half of the required laboratories in the
State, and has not inspected any of the required out-of-state
labs. State law has required inspection of out-of-state
laboratories since 1996, but LFS did not begin inspecting them
until November 2014. In 2014, the LFS failed to inspect 93% of
these labs.
According to the State Auditor, "we believe Laboratory Services'
workload largely duplicates federal oversight with no meaningful
benefit to consumers. State law and CLIA are nearly equivalent
in their mandates, and the oversight each requires is redundant:
Both Laboratory Services and CMS collect fees from laboratories
to perform inspections, monitor proficiency testing, investigate
complaints, and issue sanctions. Eliminating the portion of
Laboratory Services that we have found to be exceedingly
deficient for many years would end the duplicate oversight and
the duplicate fees. CMS has processes in place to ensure that it
effectively administers CLIA; therefore, relying on CLIA would
keep the public health benefits of laboratory monitoring intact,
as they are today, while reducing the regulatory burden on
California's clinical labs."
In short, the current system of state licensure for clinical
laboratories may not provide any additional benefits or
protections to consumers.
Prior Related Legislation. SB 744 (Strickland), Chapter 201,
Statutes of 2009, authorized LFS to contract with accreditation
organizations, if approved by LFS, to serve as the state
inspecting agent. If a laboratory earned accreditation from one
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Page 24
of these organizations, the laboratory would meet the state
inspection requirement. This bill was sponsored by the CDPH.
ARGUMENTS IN SUPPORT:
The California Society of Pathologists writes in support, "[This
bill] does not disrupt current unique California personnel
standards or the enforcement of those standards. The specifics
of the reform can be debated but it is clear that reform of the
current LFS licensing authority is long overdue."
The California Society of Dermatology & Dermatological Surgery
(CalDerm) writes in support, "This bill would save precious
health care resources by ending the State's redundant licensing
requirements - including ending the cost of redundant licenses
and enabling inspection and enforcement personnel to focus on
more critical issues."
The California Chapters of American College of Physicians write
in support, "This bill would save precious health care resources
by ending the State's redundant licensing requirements -
including ending the cost of redundant licenses and enabling
inspection and enforcement personnel to focus on more critical
issues."
The California Hospital Association writes in support, "The
[2015 State Auditor's report states] that since the problems
that have plagued LFS have persisted, the state's consumers
have, in effect, been relying on federal oversight from the
[CMS] through its administration of [CLIA]. LFS' oversight of
laboratory facilities largely duplicates federal oversight with
no meaningful benefit to consumers, yet both LFS and CMS collect
fees from laboratories to perform inspections, monitor
proficiency testing, investigate complaints, and issue
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sanctions. [This bill] would repeal state law requiring that
laboratory facilities be licensed by the state, thus reducing
the regulatory and financial burden on laboratory facilities.
CHA does support the continuation of the personnel standards and
any efforts to ensure the enforcement of these standards."
ARGUMENTS IN OPPOSITION:
The Engineers and Scientists of California, IFPTE Local 20
writes in opposition, "Federal law is different in this area and
the feds are not going to enforce this state's laws. Rather, we
should be providing more stringent direction to the [CDPH] and
[LFS] to ensure that they do their job protecting patients."
The California Labor Federation writes in opposition, "[T]he
repeal of California laws regulating clinical laboratories would
only erode quality standards. California's regulations were put
into place to respond to specific concerns, and despite the
regulator's lack of oversight, those laws are still needed. We
cannot depend on the federal government to enforce state law.
Rather than throw out state law, we should work to find a way to
make the state regulator more effective and thereby preserve
important state protections for patients and workers."
The California Association of Bioanalysts (CAB) writes in
concern, "We urge you to address the root cause for the
unfavorable State audit, rather than reacting hastily to abolish
a licensure that, as far as the CAB is concerned, has provided
the clinical laboratories in the State of California with much
needed oversight and accountability."
IMPLEMENTATION ISSUES:
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1)If the state clinical laboratory license requirements are
removed, all medical and laboratory records should be
maintained.
2)If state licensure of a clinical laboratory is repealed, CDPH
should maintain its authority to inspect labs for personnel
standards and impose corrective actions or citations and
fines, as appropriate. The appropriate number and frequency of
inspections is debatable and the practicality of surprise
inspections versus scheduled biennial inspections may not be
implemented in such a way that clinical laboratories maintain
the highest level of consumer protection in regards to tests
and examinations, record maintenance, and proper training of
employees.
3)It may be useful to amend the current state licensure
structure to a modified compliance structure. This modified
structure would require CDPH to recognize accreditation
organizations that are approved under the federal CLIA and
require CDPH to monitor labs for compliance with state
standards that are more stringent than federal standards. This
modified structure would also authorize the state to
concentrate its resources on upholding personnel standards,
allowing the CDPH to focus on the provisions that go above and
beyond what is required by the federal CLIA, during
inspections and complaint investigations.
4)Although stakeholders maintain there are distinct and
stringent differences between state and federal law, it is
unclear what those differences actually are, and can make
inspections, mandated or not, difficult to conduct
consistently. The author should consider requiring CDPH to
make these differences available to the public.
Amendments:
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1)To address the maintenance of records issue raised above, the
bill should be amended as follows:
On page 25 after lines 1-6, insert:
"1272.1(a) Whenever a clinical laboratory ceases operations,
the laboratory owners, or delegated representatives of the
owners, and the laboratory directors shall notify the
department of this fact, in writing, within 30 calendar days
from the date a clinical laboratory ceases operation. For
purposes of this subdivision, a laboratory ceases operations
when it suspends the performance of all clinical laboratory
tests or examinations for 30 calendar days at the location for
which the clinical laboratory is licensed or registered.
(b)(1) Notwithstanding any other provision of law, owners and
laboratory directors of all clinical laboratories, including
those laboratories that cease operations, shall preserve
medical records and laboratory records, as defined in this
section, for three years from the date of testing,
examination, or purchase, unless a longer retention period is
required pursuant to any other provision of law, and shall
maintain an ability to provide those records when requested by
the department or any duly authorized representative of the
department.
(2) For purposes of this subdivision, "medical records" means
the test requisition or test authorization, or the patient's
chart or medical record, if used as the test requisition, the
final and preliminary test or examination result, and the name
of the person contacted if the laboratory test or examination
result indicated an imminent life-threatening result or was of
panic value.
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(3)For purposes of this subdivision, "laboratory records"
means records showing compliance with CLIA and this chapter
during a laboratory's operation that are actual or true
copies, either photocopies or electronically reproducible
copies, of records for patient test management, quality
control, quality assurance, and all invoices documenting the
purchase or lease of laboratory equipment and test kits,
reagents, or media.
(4)Information contained in medical records and laboratory
records shall be confidential, and shall be disclosed only to
authorize persons in accordance with federal, state, and local
laws.
(c)The department or any person injured as a result of a
laboratory's abandonment or failure to retain records pursuant
to this section may bring an action in a court of proper
jurisdiction for any reasonable amount of damages suffered as
a result thereof."
2)To address the issue of enforcement authority, the author
should amend the bill to include:
a) Authority for CDPH to impose corrective actions,
citations and fines, and sanctions; and,
b) Authority for CDPH to enter clinical laboratories to
enforce state law and regulation including, but not limited
to, state standards that are more stringent than federal
standards.
3)To address the issue of a modified compliance structure, the
author should amend the bill to:
a) Require CDPH to recognize accreditation organizations
that are approved under the federal CLIA;
b) Require CDPH to monitor, inspect and investigate
unaccredited laboratories for compliance with state
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standards that are more stringent than federal standards;
and,
c) Authorize the state to concentrate its resources on
upholding personnel standards
4)To address the issue of transparency in differences between
state and federal law with respect to clinical laboratories,
the author should amend the bill to:
Require CDPH post on its Internet web site, a comprehensive
list of the differences between state and federal law.
REGISTERED SUPPORT:
California Society of Pathologists
California Society of Dermatology & Dermatologic Surgery
(CalDerm)
California Chapters of American College of Physicians
California Hospital Association
REGISTERED OPPOSITION:
Engineers and Scientists of California, IFPTE Local 20
California Labor Federation
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California Association of Bioanalysts
Analysis Prepared by:Gabby Nepomuceno / B. & P. / (916)
319-3301, Vincent Chee / B. & P. / (916) 319-3301