Martha M Smith - ASCLS New Jerseyascls-nj.org/Documents/Speaker Handouts 2015 SPring/pdfs... ·...

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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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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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


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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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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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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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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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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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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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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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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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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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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New Jersey has two levels.

– the original eight waived tests

– everything else

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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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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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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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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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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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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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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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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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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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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


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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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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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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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


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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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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Safety Policies and Procedures

Blood Borne Pathogens

Medical Waste

Hepatitis B Vaccination

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Training for Physician Office Laboratories

CMS Ready? Set? Test!

http://www.cdc.gov/dls/waivedtests

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http://www.cdc.gov/dls/waived


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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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]

[email protected]

Website:http://www.state.nj.us/health/phel/clis.shtml

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mailto:[email protected]

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