Wednesday, November 6, 2013

Clinical Laboratory Licensing and Certification; What is the difference?

Laboratory Certification - Laboratory Licensing - What does it all mean?

 With over 239,000 clinical laboratory facilities registered in the US under CLIA - Clinical Laboratory Improvement Amendments; the public can get quite confused about regulations, certification, and licensing of these facilities.  Under CLIA, there are 29 different categories of Clinical Laboratories.  These can range from a mobile facility on wheels, health fares, hospital labs, and the mega reference labs performing millions of tests per year.  Various States operate licensing or permit programs of clinical labs.  The employees working the lab bench performing the testing of specimens are regulated by certification agencies and State level licensing via each locale.  So what is Laboratory certification?  What is the difference between certification and licensing?  Can a laboratory be certified but not licensed?  Can labs be licensed but not certified?  Can labs lose either certification or licensing and continue to operate?  I will try to answer these questions and explain concepts which can be confusing to laboratory consumers.  What is a Laboratory Consumer?  A lab consumer is you, me, the patient in general.  The doctor orders blood testing for us.  We go to a laboratory to submit specimens for testing, or the Doctor collects  specimens in the office and labs pick them up, or hospital staff come to your bed side to collect specimens.  Your specimens are received in a lab facility and tested.  Laboratory results are then delivered to the doctor who ordered your tests.  We are all consumers of lab testing facilities.  You do have a choice of who, what, where your specimens go for analysis.  What about that lab data?  What is a lab result?  What is lab data?  Laboratory data is the data produced within the laboratory from analysis of specimens; Unconfirmed data.  Clinical Laboratory Scientists test specimens by various methods and instrumentation.  Until that data is confirmed it is just that - data.  Once the data is verified as accurate and under control then the data is confirmed as laboratory results.  Lab results are then conveyed to the doctor for his or her evaluation.  This is a crucial concept to understand.  Lab data is subject to all sorts of regulations, guidelines, control, and evaluation before the data is declared laboratory results.  Just because a lab instrument issues numerical data does not mean that data is ready to be used to evaluate your medical condition or asses the health of an individual.  If quality control checks fail during the analysis of my specimen then the analysis is flawed and must be repeated and evaluated.  If my specimen does not meet guidelines for analysis then a new specimen must be obtained for testing.  Lab results are reported to our doctors.  Lab data is the unverified numbers or raw data issued by the testing method.  You nor I want lab data reported to the doctor.  We want verified lab results being perused by the doctor.

Laboratory licensing is sometimes synonymous with the Lab Permit.  Laboratories are a business.  Labs pay taxes to cities, states, and the federal government.  Various fees, registration fees, rent for building space, etc.  are paid by clinical labs.  A lab must have a permit to operate and test specimens.  Depending on the location of the lab facility a state permit is required and issued by the state department of health to the laboratory on an annual, bi-annual, or some other time period basis.  Renewal is required.  Some states also require inspection of the laboratory facility to maintain license or a lab operator permit.  To complicate the licensing issue, some specimens are collected from patients and transported across state lines or across the country to a central testing facility.  In those cases, the state where the specimens originate have jurisdiction over the performing laboratory no matter where the lab is located.  I personally know of a clinical laboratory that holds national certification but lost a state license due to revocation.  Even though this is a laboratory with quality processes, this facility is analyzing specimens without proper license from a state where samples are collected and jurisdiction is owned.  These lab results reported to physicians are reliable however there is great liability and risk if this facility where to be embroiled in a litigious process.  Basically, in absence of proper licensing laboratories are a risk to public health - especially when there is revocation involved.

Certification is the process a clinical laboratory under takes to gain prestige amongst other clinical laboratories and other competing laboratories; competing for our business.  Is certification of a clinical laboratory required?  No.  However, certification can be a supporting factor in the permit or licensing procedure of a laboratory.  Just depends on the licensing body of that facility.  Various organizations can certify clinical laboratories; the most notable is CAP - College of American Pathologists.   CAP certification is optional is some states or locales; however, that is a tricky road to embark on if you are a lab owner.  CAP certification is often inter-twined in the licensing procedure.  Just depends where the lab is physically located.  Hospitals can also be monitored/certified by JCAHO - Joint Commission on Accreditation of Health care Organizations.

CLIA Certification is different than lab certification described above.  CLIA certification is the permit or license if you will issued by the federal government so that a clinical laboratory can receive payment from CMS - Centers for Medicare and Medicaid Services.  A lab must be CLIA Certified to receive payments for testing specimens of patients enrolled in medicare or medicaid.

So, now that we know about laboratory certification and licensing what now?  Is this important?  Should a patient be concerned about these concepts when they visit their doctor for a check up?  The answers are yes, yes.  There are labs out there that either are not certified, not licensed, or have lost license or certification, or otherwise there is a lapse of one, both , or the other.  If there is a loss of either license or certification the big question is why?  Did the loss occur because of quality issues, performance issues, or some sort of regulatory infraction?  Either way, would you want your specimens used to screen your health analyzed by a laboratory that has lost certification or license?  I think not.  Do you feel comfortable bringing your car to Joe Smoe shade tree mechanic or your next door neighbor to fix your transmission?  No you don't and you would not do that.  You want someone who knows what they are doing and can prove it. The same with a clinical laboratory.  You want your specimens analyzed at a fully licensed, boastfully certified laboratory that can prove it 24/7/365.

But does a patient really have a choice where their specimens wind up to be tested?  Well sort of.  That depends on their doctor.  Some doctors have business relationships with clinical laboratories.  There is much federal regulation about this area of health care involving the prevention of kick-backs by labs to referring doctors.  The relationship is a loose agreement that the lab will pick up specimens and deliver medical reports to the doctor and may also provide supplies to collect specimens.  Anything more than that basic arrangement between doctor and laboratory and someone is going to jail.  There has been recent re-occurrence of kick-back payments by labs to doctors whereby thousands of dollars are passed to the doctor each year for the lab business from the doctor.  Prosecution of these cases has resulted in doctors going to jail for a long time.

However, you do have a choice where your specimens go.  When the doctor orders testing the order can be written on paper, or script.  You can take that script and go to any lab of your choosing.  You can do your own research and verify the certification and or licensing of labs and go to the one you are satisfied with.  Otherwise, you can let your doctor choose where the specimens go.

Be wise about your health care and be an informed consumer of health services.  Not all labs hold the proper license and certification to perform testing of your laboratory specimens.

To find a CAP Accredited Laboratory near you anywhere in the world click this link:
CAP Certified Laboratories
To find Laboratories that hold License with New York State DOH click this link:
NY State Clinical Laboratory Permit Holders
To find a licensed laboratory in Florida click this link;
Florida Laboratories
For more info about Laboratory Certification and certification of Clinical Laboratory Scientists
click this link; ASCP

Scott R. Mayorga
Straight Talk From The Hematech

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