Ask The Expert

We bought a waived urine analyzer and were told by the sales rep we only had to do quality controls when we opened a new bottle of strips. The administrator said we have to run controls daily. Why is this?
Different accrediting bodies have different rules for waived testing. CLIA makes the overall rules, but if your lab is inspected by organizations other than CLIA, their rules “overrule” CLIA. It’s like when you were a kid and ask your father for something. Dad says “Yes”. Then Mom (the BOSS), says “Overruled!!” Here is a breakdown of some of the rules for automated waived testing listed by accrediting body:
 Automated waived analyzers:
CLIA – Follow manufacturer’s requirements for QC as a minimum level of compliance
JCAHO - All automated waived instruments must have two levels of controls run each day of patient testing
CAP - All automated waived instruments must have two levels of controls run each day of patient testing. In addition, linearity (reportable range) must be assessed every six months

Our CLIA certificate will be expiring soon. Are we required to submit a renewal application?

No. All facilities with active CLIA certificates will receive a renewal billing from the CMS fee contractor prior to the actual certificate expiration date. Once the laboratory pays the certificate fee to the CMS contractor, a new CLIA certificate will be automatically generated and mailed to the laboratory’s mailing address. If you do not receive a renewal bill within 8 weeks of your certificates expiration, contact your state’s CLIA office.

I want to read the rules for CLIA. Where can I get a printed copy of the CLIA Federal regulations?

Superintendent of Documents
Government Printing Office
Attn:  New Order
P.O. Box 371954
Pittsburgh, PA 15250-7954
Telephone: (202) 512-1800
FAX: (202) 512-2250

The clinic I work for has a PPM certificate and the doctor wants me to look at slides under the microscope. I am a Medical Assistant. Who can perform the microscopic tests that are part of the Provider Performed Microscopy (PPM) laboratory certificate? 
 Under this certificate, laboratory tests must be performed A) in an office setting, and B)be performed by a provider.  A provider is a physician, dentist, or mid-level practitioner (nurse practitioner, physician's assistant, or nurse midwife).  These tests CANNOT be performed by anyone else other than a MLT or MT. The test specimens to be examined are limited to the microscopic examination of the following body fluids: urine, wet mounts including the presence/absence of bacteria, fungi, parasites; and human cellular elements in vaginal, cervical, and skin preparations.  Nasal smears for granulocytes, fecal exams for leukocytes, and sperm qualitative analysis limited to the presence or absence of sperm and the detection of sperm motility are also performed under this certificate. Competency to perform these tests must be demonstrated on an annual basis.

With half of our laboratory's personnel out sick or on vacation and an increasing volume of tests, our laboratory is short-handed, especially in our high complexity testing areas. Can you review who can work and supervise this area of testing?
 Here is a review of the high complexity testing personnel requirements. Any of the following individuals qualify to perform high complexity testing:

1.  Doctor of medicine or osteopathy, with a current State license.
2.  Doctoral, masters, or bachelors degree in a chemical, physical, biological or clinical laboratory science.
3.  Associate degree in laboratory science or medical technology.
4.  Education and training equivalent to an associate degree includes:

  
 Education:
 (A) At least 60 semester hours or equivalent from an accredited institution that, at a minimum, include either -
  (1) 24 semester hours of medical laboratory technology courses; or
(2) 24 semester hours of science courses that include -
 (i) 6 semester hours of chemistry;
(ii) 6 semester hours of biology; and
(iii) 12 semester hours of chemistry, biology, or medical laboratory technology in any combination.

 Laboratory Training (either of the following):
 (A) Completion of a clinical laboratory training program approved by HHS; or
 (B) Completion of at least 3 months of documented laboratory training in each specialty in which the individual performs high complexity testing.

 5.  Achieved a passing score on the proficiency examination by HHS (HEW exam).
* 6. On or before April 24, 1995 be a high school graduate or equivalent and have either-
  ;
(A) Graduated from a medical laboratory or clinical laboratory program approved by HHS, or
 (B) Successfully completed an official U.S military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical laboratory Specialist.

* 7.  On or before April 24, 1995 be a high school graduate or equivalent and have received appropriate training and education for the high complexity testing the individual is authorized to perform. The training and education must be documented. (Individuals with only a high school degree and training who began performing high complexity testing after April 24, 1995 must now have an associates degree or equivalent.)
In general terms, after September 1, 1997, any testing personnel you hire must meet one of the first four qualifications if the individual has no previous laboratory work experience. If the individual meets one of the other qualifications, you must have appropriate documentation of work experience and the type of high complexity testing performed, or for (5) proof of the HHS examination. Testing personnel who meet the grandfather clauses (6 and 7) are only allowed to perform the high complexity testing they were performing prior to April 24, 1995.
*Supervisory Requirements: If testing personnel with only a high school degree or equivalent and training (6 or 7) began performing high complexity testing between January 19, 1993 and April 24, 1995, these individuals require on-site supervision by a general supervisor. If the testing personnel was performing high complexity testing prior to January 19, 1993, the regulation does not require on-site supervision by a general supervisor, but does require that high complexity testing performed by these individuals be reviewed by a general supervisor within 24 hours. Ref: CMS/CLIA Personnel Guidelines, 2008