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Medical Office Laboratory Practices: Strategies to Ensure Compliance with State and Federal Regulations
Martha M SmithService Director, Policy Planning and Regulatory Compliance
Service Director, Clinical Laboratory Improvement Services,
Public Health and Environmental Laboratories,
NJ Department of Health
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Strategies to Ensure Compliance
Objectives
Upon completion of this activity, participants should be better able to:
Determine the need for NJ laboratory licensure and/or CLIA certification for
office practices based on the testing being offered;
Describe and implement office laboratory procedures that conform to
regulatory requirements so to improve the quality of laboratory services
offered;
Assess office laboratory staff’s knowledge and skills in implementing Good
Laboratory Practices;
Formulate appropriate educational interventions for laboratory staff in order
to enhance quality and patient safety, and reduce testing errors.
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Strategies to Ensure Compliance
What is CLIA and why is certification required?
Clinical Laboratory Improvement Amendments of 1988
42 CFR Part 430 to end
Required for all laboratories performing testing on
human specimens
Required for “laboratories seeking payment under the
Medicare and Medicaid programs”
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Strategies to Ensure Compliance
Clinical Laboratory: a facility for the biological,
microbiological, serological, chemical,
immunohematological, hematological, biophysical,
cytological, pathological, or other examination of
materials derived from the human body for the purpose
of providing information for the diagnosis, prevention, or
treatment of any disease or impairment of, or the
assessment of the health of, human beings. These
examinations also include procedures to determine,
measure, or otherwise describe the presence or
absence of various substances or organisms in the
body.4
Strategies to Ensure Compliance
Any facility performing testing of bodily
specimens for the purposes previously
described must have a valid CLIA certificate
appropriate to the testing performed. Certificate of Waiver
Provider Performed Microscopy
Registration
Compliance
Accreditation
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Strategies to Ensure Compliance
CLIA categorizes laboratory tests as either waived or non-waived.
The non-waived tests may be further categorized as moderate
complexity, including Provider Performed Microscopy or high
complexity.
Notices are published in the Federal Register and every test,
system, assay, and examination are categorized by complexity.
The complexity level of the testing being performed dictates all
personnel qualifications.
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Strategies to Ensure Compliance
Is it Waived, Moderate, or High Complexity?
1. Manual white blood cell differential
2. Trichomonas
3. Glucose - J&J One Touch
4. Automated CBC and differential
5. Hepatitis B surface antigen
6. Real Time PCR for Influenza A & B
7. Cholesterol
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/se
arch.cfm
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Strategies to Ensure Compliance
In addition to a CLIA certificate, a facility performing testing shall
have a New Jersey Clinical Laboratory license except if testing is
limited to the following tests which were designated as CLIA
waived in 1992: Dipstick or Tablet Reagent Urinalysis
Fecal Occult Blood
Ovulation – Visual color comparison
Urine pregnancy- Visual color comparison
Erythrocyte sedimentation rate non-automated
Hemoglobin copper sulfate non-automated
Blood glucose using FDA cleared home use device
Spun microhematocrit
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Strategies to Ensure Compliance
N.J.S.A. 45:9-42.26 New Jersey Clinical Laboratory
Improvement Act, eff. 8/1/75
N.J.A.C. 8:44 Operation of Clinical Laboratories, eff. 9/18/78
NJ Board of Medical Examiners
13:35-3.6
Statute: Article 3A: Bio-Analytical Laboratories (1953)
45:9-42.2
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Strategies to Ensure Compliance
Note that New Jersey’s rules for clinical laboratories at
N.J.A.C. 8:44 do not recognize tests that have been
designated as CLIA waived subsequent to 1992.
These include drugs of abuse, HIV, rapid group A
strep, rapid influenza A & B, tear chemical tests, and
others.
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Strategies to Ensure Compliance
So why two? Both intend to protect the public health.
Most state licensure programs were in effect prior to
the multiple, large changes of CLIA ‘88.
CLIA ‘67 basically dealt with interstate laboratory
testing – the location of the laboratory was more
important than the functions of the laboratory.
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Strategies to Ensure Compliance
Of the 50 states and the District of Columbia:
15 have state regulations for laboratory licensing
6 have state regulations for state certification
22 use the federal CLIA regulations for governing
clinical laboratories
8 no data (AK,DE,MI,NE,OK,SC,UT,WY)
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Strategies to Ensure Compliance
New Jersey’s rules for the operation of clinical
laboratories are more stringent than Federal CLIA
regulations particularly for laboratories performing only
CLIA waived tests that are not waived under New
Jersey’s rules.
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Strategies to Ensure Compliance
One of the biggest differences between the two
regulatory bodies is that CLIA recognizes four
different levels of testing method classification.
– Waived
– Provider Performed Microscopy
– Moderate Complexity
– High Complexity
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Strategies to Ensure Compliance
New Jersey has two levels.
– the original eight waived tests
– everything else
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Strategies to Ensure Compliance
NJ requires laboratory directors to hold a NJ
Board of Medical Examiners Bioanalytical
Laboratory Director License, with one
exemption.
CLIA requires this only if the individual state
requires it.
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Strategies to Ensure Compliance
NJ BME 45:9-42.20 Exemption
“Physicians or members of other professions who, in
their private practices perform bio-analytical laboratory
tests in their own offices or laboratories for their own
patients pursuant to licenses respectively granted to
them according to law.”
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Strategies to Ensure Compliance
The CLIS Clinical Laboratory Licensing Unit recognizes
this exemption.
Changes in what constitutes a physician practice in the
past five to ten years has made this much more difficult
to interpret.
The NJ regulations need a much better definition of
physician office laboratory.
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Strategies to Ensure Compliance
Personnel Records
Both CLIA Non-Waived and NJ Non-Waived require
personnel training records which include diplomas,
degrees, certificates, training and experience, and
continuing education and an assessment of these
qualifications with meeting the federal or state testing
personnel standards
CLIA requires annual competency assessments, semi-
annually during the 1st year of employment.
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Strategies to Ensure Compliance
What is Quality Control?
A generic term that refers to the monitoring and assessment of laboratory testing processes to identify problems and maintain accurate and reproducible results.
Why is it performed?
checks the instrument
checks the reagents
checks the operator
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Strategies to Ensure Compliance
NJ requires 2 levels of control every day of patient testing
CLIA requires the same for non-waived testing and will offer what is called the Individualized Quality Control Program beginning 1/1/16
This IQCP is NOT recognized in NJ at this time
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Strategies to Ensure Compliance
Quality Control – Internal vs External
Internal Controls or built-in controls are common to
waived testing devices/methods.
Good internal QC results tell you that the test is
working as it should – that enough sample was
added – that it is moving through the device or test
strip – and that the electronic aspects of the device
are working correctly
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Strategies to Ensure Compliance
Quality Control – Internal vs External
External controls may come with a test kit or may
need to be ordered separately.
Good External QC results tell you that the entire
process was performed correctly and provides
confidence that the result is a quality result.
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Strategies to Ensure Compliance
QC Performance
Per state and federal non-waived testing regs – QC
should be run every day that patients are tested by the
same personnel who routinely perform patient testing.
CLIA Waived tests require at minimum that external
controls be run:
With each new test kit/reagent shipment received
When there is a change in lot numbers
With each new testing personnel
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Strategies to Ensure Compliance
What do you do when QC results are not as
expected?
Don’t report patient results
Check that the procedure was followed
Check for outdated reagents or test devices
Check for proper reagent storage
Check that the correct controls were used
Follow any package insert troubleshooting steps
Call the available hotline for technical assistance25
Strategies to Ensure Compliance
Proficiency Testing
Why is it performed? To verify the accuracy and
reliability of the laboratory test.
Who performs it? testing personnel.
NJ requires PT for all licensed specialties and tests.
CLIA requires PT for all regulated analytes (except
those performed used a waived method/kit/or
instrument)
and recommends PT for waived tests.
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Strategies to Ensure Compliance
Quality Assurance (QA)
What is it and how is it different from Quality Control (QC)?
QA is the planned and systematic activities implemented to produce quality results.
QC is one of those activities.
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Strategies to Ensure Compliance
Procedure Manual
A written procedure manual for all tests, assays, and
examinations performed by the laboratory must be
available to, and followed by, laboratory personnel. The
manufacturer's test system instructions or operator
manuals may supplement but not replace the
laboratory's written procedures for testing or examining
specimens.
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Strategies to Ensure Compliance
Record Keeping
Documentation is another part of quality assurance.
Good laboratory practice is to document all steps of the testing process. This includes:
Records of instruments and maintenance
Reagent lot numbers and dates received, opened & expired
Test kit/reagents manufacturer’s instructions
QC and proficiency records
Patient testing
Staff training and competency assessment records29
Strategies to Ensure Compliance
Good record keeping makes it easy to retrieve records.
Records should be reviewed periodically by the
medical director or person overseeing testing to:
Verify information
Assess test performance
Identify & resolve problems that could affect test results
Maintain patient and personnel information
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Strategies to Ensure Compliance
NJ requires the following records:• Requisition
• Work records/instrument printouts
• Patients test report
Most records must be kept for at least 2 years
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Strategies to Ensure Compliance
Safety Policies and Procedures
Blood Borne Pathogens
Medical Waste
Hepatitis B Vaccination
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Strategies to Ensure Compliance
Training for Physician Office Laboratories
CMS Ready? Set? Test!
http://www.cdc.gov/dls/waivedtests
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Strategies to Ensure Compliance
From five NJ offered in-person trainings offered
in 2013/14:
NJ Licensed Physician Office Laboratories’ staff
were found to be more knowledgeable about Good
Laboratory Practices (GLP)
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Strategies to Ensure Compliance
NJ has set the bar higher – is it necessary to maintain?
How do the state regulations keep a high quality
standard and recognize the 21st century technology?
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Contact Us At:
New Jersey Department of Health
Clinical Laboratory Improvement Services
Public Health and Environmental Laboratories
PO Box 361
Trenton, NJ 08625-0361
Phone: 609-406-6830
Fax: 609-406-6863
Email: [email protected]
Website:http://www.state.nj.us/health/phel/clis.shtml
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