The Nuts and Bolts of Directing and Performing Laboratory Tests in

The Nuts and Bolts of Directing and
Performing Laboratory Tests in
Your California Practice
Jan Otey, CLS, Examiner II
Room: Colton 2
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CLW2 – The Nuts and Bolts of Directing and Performing Laboratory
Tests in Your California Practice
Jan Otey, CLS, Examiner II
This course material and information was developed independently
of any assistance.
I do not have any financial arrangements or affiliations with any corporate
organizations (ex. Salary, honorarium, etc.)
P R E S E N T E D B Y:
Jan Otey, CLS, MT (ASCP), Examiner II
California Department of Public Health
Laboratory Field Services
Sunday, November 11, 2012
Course Objectives
At the conclusion of this program
you should understand:
What Laboratory Field Service (LFS)
Why LFS and AB761 may be relevant
to your practice.
The responsibilities of a Laboratory
(Course Objectives cont.)
How to successfully apply for a Clinical
Laboratory Registration and a CLIA
Certificate of Waiver.
 The most common application
problems that delay approval.
 Waived laboratory inspections.
 The testing documentation that you
would be expected to maintain.
Laboratory Field Services
Part of California Department of Public
Health and the Office of the State Public
Health Laboratory Director
◦ License laboratories, laboratory
personnel, tissue banks, and blood banks
◦ State laboratory inspections
State agent for Center for Medicare and
Medicaid Services (CMS)
◦ CLIA laboratory inspections
◦ Responsible for CLIA certification
Why should I care?
California Business & Professions Code
Chapter 3
§1241. (a) This chapter applies to all clinical
laboratories in California or receiving
biological specimens originating in California
for the purpose of performing a clinical
laboratory test or examination, and to all
persons performing clinical laboratory tests
or examinations or engaging in clinical
laboratory practice in California or on
biological specimens originating in California,
except as provided in subdivision (b).
California Business &
Professions Code Changes
Passage of new law, AB 761 (Roger
Hernandez) effective January 1, 2013
◦ An act to amend Sections 1206.5,
1209, and 3041 of the Business and
Professions Code, relating to
B&P Code §1206.5
§1206.5. (a) Notwithstanding subdivision (b) of Section
1206 and except as otherwise provided in Section 1241,
no person shall perform a clinical laboratory test or
examination classified as waived under CLIA unless the
clinical laboratory test or examination is performed under
the overall operation and administration of the laboratory
director, as described in Section 1209, including, but not
limited to, documentation by the laboratory director of the
adequacy of the qualifications and competency of the
personnel, and the test is performed by any of the
following persons:
(13) A licensed optometrist as authorized under
Chapter 7 (commencing with Section 3000).
(14) Other health care personnel providing direct
patient care.
B&P Code §1209
§1209. (a) As used in this chapter, "laboratory
director" means any person who is a duly licensed
physician and surgeon, or, only for purposes of a
clinical laboratory test or examination classified as
waived, is a duly licensed naturopathic doctor, or a
duly licensed optometrist serving as the
director of a laboratory which only performs
clinical laboratory tests authorized in
paragraph (10) of subdivision (e) of Section
3041 that are classified as waived, or is licensed
to direct a clinical laboratory under this chapter and
who substantially meets the laboratory director
qualifications under CLIA for the type and complexity
of tests being offered by the laboratory.
B&P Code §3041
(e) An optometrist who is certified to use therapeutic
pharmaceutical agents pursuant to Section 3041.3 may also
perform all of the following:
(9) Ordering of smears, cultures, sensitivities, complete
blood count, mycobacterial culture, acid fast stain, urinalysis,
tear fluid analysis, and X-rays necessary for the diagnosis of
conditions or diseases of the eye or adnexa. An optometrist
may order other types of images subject to prior consultation
with an ophthalmologist or appropriate physician and
(10) A clinical laboratory test or examination
classified as waived under CLIA and designated as
waived in paragraph (9) necessary for the diagnosis
of conditions and diseases of the eye or adnexa, or
if otherwise specifically authorized by this chapter.
January 1, 2013
An optometrist will be
able to direct a
California waived
laboratory in which
“waived” tear fluid
analysis and urinalysis
laboratory tests may
be performed by the
Laboratory Director
Overall operation and administration
Technical and scientific operation
Selection of procedures
Reporting of results
Compliance with all State and Federal
Laboratory Director
CBPC §1209(b) (1) The laboratory director is responsible for the
overall operation and administration of the clinical laboratory,
including administering the technical and scientific operation of a
clinical laboratory, the selection and supervision of procedures,
the reporting of results, and active participation in its operations
to the extent necessary to ensure compliance with this act and
CLIA. He or she shall be responsible for the proper performance
of all laboratory work of all subordinates and shall employ a
sufficient number of laboratory personnel with the appropriate
education and either experience or training to provide
appropriate consultation, properly supervise and accurately
perform tests, and report test results in accordance with the
personnel qualifications, duties, and responsibilities described in
CLIA and this chapter.
Director’s Attestation
Assume all director responsibilities
Held jointly responsible with the owner for any
violations of law by this clinical laboratory
Any false statements made in obtaining or
retaining State registration or CLIA certification
may be grounds for revocation
Director and the laboratory owner are jointly
responsible for notifying LFS of any changes in
the laboratory ownership, directorship, name or
location within 30 days
Director will be responsible as director until
CDPH receives a signed statement from you
notifying the Department of your resignation.
Instructions for Applying for a California Clinical Laboratory
Registration and CLIA Certificate of Waiver
If you wish to apply for a CLIA Certificate of Waiver , you must also apply for a state
registration, not a state license.
California Clinical Laboratory Registration Fee and Required Documents:
● Registration fee payable to the State of California Department of Public Health.
The registration fee is non-refundable and is subject to change with each fiscal year.
The fee schedule may be downloaded from:
● Federal CLIA program will bill you separately for the CLIA certification fee.
● Original signatures must be on all forms where signatures are required.
State forms to complete and submit:
● LAB 155 — Application for Clinical Laboratory Registration
● LAB 116 — Laboratory Personnel Report
● LAB 183 — Director Attestation
Federal form to complete and submit:
● CMS 116 — CLIA application, unless already certified by CMS
New applications
◦ ~120/month
◦ ~14,000/year
Change in Director
or Owner
Missing or
incomplete forms
Time Frames
Your office to reviewer ~ 1 week
 State database entry ~ 1 week
 CLIA database entry < 30 days
◦ Invoice from CMS
CLIA number to State ~ 1 week
 Activation of State Registration
~ 1 week
 CLIA certificate mailed ~ 1 week
after payment received
2 of every 5 new applications
Application returned
and/or incomplete
application letter
California Registration Errors
#4. - Legal name of owner (e.g.
corporation name)
#6. - Hours per week on-site
Signature of Laboratory Director
AND Laboratory Owner
CLIA Application Errors
Name of Director (Laboratory)
 Type of Certificate not specified
 Estimated total volume of waived
 Be sure to sign and date application
 Do NOT submit data in sections:
◦ V – Multiple sites
◦ VII – PPM testing
◦ VIII – Non-waived testing
CLIA Application
VI - Waived testing (from page 3 of CMS 116 form)
Identify the waived testing performed. Be as specific as
possible. This includes each analyte test system or device
used in the laboratory.
e.g. (Osmolarity - TearLab)
(Adenovirus - Rapid Pathogen Screening (RPS))
(Adenovirus - Nicox)
(Urinalysis - ? Manufacturer)
Indicate the estimated total annual test volume for all
waived tests performed ________________
Back to square one
See slide #20 Time Frames
Ready to start testing
California Clinical Laboratory
CLIA Certificate of Waiver
State Laboratory Registration – 1 year
◦ Expiration date:
Renewal forms 75 days prior
>30 days + 25% delinquent fee
>60 days – termination letter
Letter to CLIA to terminate
CLIA Certification – 2 years
Inspections ?
CLIA Certificate of Waiver
Texas – 15,773
Florida – 14,958
California – 14,263
Inspections ?
State / CLIA
TearLab Osmolarity System
Documentation of:
◦ Date received, lot number, & exp. date
of each shipment of test cards
◦ Date & Electronic Check Card test
results each day of use
◦ Date and external control results for
 Each new test card shipment
 Each new test card lot number
 Monthly to check storage
RPS - AdenoPlus
Documentation of:
◦ Date received, lot number, & exp. date
of each shipment of test cassettes
◦ Date of external control results
 Each new shipment
 Each new lot number
 Once by each new untrained operator prior
to patient testing
In Conclusion
A request from our program techs
who will be processing your
Please include a cover letter designating
the best person to call or e-mail, including
their direct line and e-mail address, if
clarification of your application is needed.
Contact Information
California Department of Public Health
Laboratory Field Services
850 Marina Bay Parkway
Richmond, CA 94804-6403
Jan Otey, Examiner II
(510) 620-3816
Fax (510) 620-3688
E-mail: [email protected]

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