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QBC STAR: Working with CLIA
Click the following sections for more information on CLIA requirements for the QBC STAR system:
What is CLIA?
Quality Requirements for Moderately Complex Tests
Written Procedure Manual
Proficiency Testing
Personnel Training and Evaluation
Laboratory Director
Other Positions
Quality Assessment
Internal Quality Checks
External Quality Checks
CLIA Inspections
Application for CLIA Certification
What is CLIA?
CLIA is an acronym for Clinical Laboratory Improvement Amendments.
It sets forth uniform quality standards for laboratories and applies to all entities that perform tests for health purposes on human specimens.
CLIA requirements are based on the complexity of tests performed (waived, moderate, or high).
QBC hematology systems, such as the STAR, are considered moderate complexity test systems, and therefore must meet quality requirements for moderately complex testing.
Quality Requirements for Moderately Complex Tests
Written Procedure Manual
A procedure manual is a detailed sequence of activities showing how the test procedure is to be performed.
It breaks down the test procedure one step at a time.
You may utilize the STAR Operator's Manual as your procedure manual if it is your policy to do so.
Please ensure personnel are informed that they must follow the procedure as stated in the Operator's manual for performing the test.
The procedure must be approved and signed by the Laboratory Director.
Proficiency Testing
CLIA requires that you participate in a Proficiency Test Program.
These programs monitor the performance of your test system.
Participants will receive five unknown samples, three times per year.
Samples are to be treated in the same manner as patient specimens.
The results are evaluated and comparisons made to other laboratories within your Peer group; laboratories using the same analyzer and tube type.
Below is a listing of Proficiency Test Providers and a chart percentage of QBC participants submitting results according to each provider.
American Proficiency Institute (API)
800-333-0958 www.api-pt.com
American Academy of Family Physician's (AAFP)
800-274-2237 www.aafp.org
American College of Physicians (PT division-Medical Laboratory Evaluation-MLE)
800-338-2746 www.acponline.org
College of American Pathologists (CAP)
800-323-4040 www.cap.org
American Association of BioAnalysts (AAB)
800-234-5615 www.aab.org
Personnel Training and Evaluation
For a link to CLIA personnel qualifications: www.cms.hhs.gov/cmsforms/downloads/cms209.pdf
Laboratory Director
CLIA specifies that a physician (MD or DO) serving as Laboratory Director must have at least one year experience supervising moderately complex testing OR complete a 20 credit course.
This course can be completed on-line at www.medicine.uiowa.edu/cme/clia/ or www.cola.org/labu.html.
The Lab Director can also attend a 2.5 day workshop provided by COLA (www.cola.org for dates and times).
Additionally, individuals with a Bachelor's degree and 2 years laboratory experience PLUS 2 years supervisory experience, or a Master's degree and 1 year experience PLUS 1 year supervisory experience also qualify to direct a moderately complex laboratory.
Other Positions
Moderately complex laboratories also have three other positions specified by CLIA:
- Clinical Consultant (Qualified Laboratory Director)
- Technical Consultant (Qualified Laboratory Director)
- Testing analyst (high school diploma and documented training)
* a single person may fill the position of Lab Director, Clinical, and Technical Consultant.
Quality Assessment
CLIA requires that the following quality standards be tested and documented on moderately complex systems:
- Specimen ID and Integrity
- Patient Confidentiality
- Personnel competency assessment
- Proficiency Testing
- Test requesting
One means of testing these quality standards is through the use of internal and external quality checks, as appropriate.
Internal Quality Checks
The QBC STAR automatically performs internal quality testing whenever it is turned on, or every eight hours if left on continuously.
External Quality Checks
Liquid controls are available for the QBC STAR through QBC Diagnostics.
Traditional quality controls consists of running at least two levels of external control material each day of patient testing.
QBC Diagnostics also offers an online Inter-Lab Quality Control (ILQC) program to provide monthly peer comparisons with statistical evaluation of your results.
To access this program, please click here.
CLIA Inspections
CLIA requires inspections every two years.
The inspections are non-punitive unless there is a failure to correct deficiencies.
Laboratories may also choose another CLIA approved accrediting agency, including
COLA (www.cola.org),
CAP (www.cap.org),
or JCAHO (www.jcaho.org) to conduct the inspections.
These organizations will assist you in preparing your laboratory for inspection, including support and training.
Fees vary, so please visit each individual site for further information on the services they provide.
Application for CLIA Certification
To apply for CLIA certification or to change Certificate Type, please consult the following website:
www.cms.hhs.gov/cmsforms/downloads/cms116.pdf
Please note that your completed CLIA application should be forwarded to the address of the local State Agency for the state in which your laboratory resides.
You should also contact this State Agency for additional forms that may be necessary to complete the registration process.
For a listing of contact information by state, please go to the following website:
www.cms.hhs.gov/CLIA/Downloads/CLIA.SA.pdf
States Requiring certification:
CA, CT, FL, HI, ID, MD, NV, PA, and WA
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