Does Your Laboratory Personnel Meet the CLIA Regulation and Accreditation Requirements?

On December 21, 2012, the Centers for Medicare and Medicaid Services (CMS) published Survey & Certification letter: (S&C-13-07-CLIA) with Brochure #10 on Personnel Competency. It cites the six minimal regulatory requirements for assessment of competency for testing personnel:

  1. Direct Observation of testing procedure
  2. Monitoring the recording and reporting of test results
  3. Review of test results
  4. Performance of instrument Preventive Maintenance
  5. Test performances, i.e. blind unknowns, etc.
  6. Assessment of problem solving skills.

Since early 2013, some CMS surveyors have joined accrediting agencies such as The Joint Commission (TJC) and College of American Pathologists (CAP) in their bi-annual lab accrediting surveys to check testing personnel’s qualification. This qualification includes proof of a minimum education requirement (usually a college diploma). Healthcare organizations need to assure the qualifications for testing personnel are fully met pursuant to the federal, state, and accrediting agency requirements. This includes personnel that perform point-of-care testing (POCT). Because this testing might be performed by non-laboratory staff, these personnel might not have the required education requirements for moderate complexity testing pursuant to the CLIA requirements.

In such cases where the testing personnel licensure is required (for example, by the state) copies of staff diplomas would not be necessary. Licensure is different than certification, which is sponsored by a private sector, nongovernmental institution, such as American Society of Clinical Pathology (ASCP). By requiring personnel licensure, the state government has taken additional measures to protect harm to the public in the state. Currently, there are 12 states with laboratory personnel licensure requirements (California, Florida, New York, North Dakota, Rhodes Island, Tennessee, Louisiana, Nevada, West Virginia, Montana and Georgia). The components of the laws for personnel licensure vary from one state to another; it usually involves a fee, a continuing education provision, and a minimum education requirement, and a professional competency requirement.

Due to the economic situation in the United States and the laboratory workforce shortage, some state government agencies have not actively enforced all compliance aspects among healthcare organizations. For example, some laboratories allow medical lab technicians (MLTs) to perform high-complexity testing due to the medical lab technologists’ (MTs) shortages across the country. However, according to CLIA regulations, MLTs should only work in moderate complexity testing areas that require limited independent judgments. The high complexity testing environments that include blood banking, microbiology identification procedures, microscopy, etc. require a high level of independent judgment and should only be performed by MTs.

Technical supervisory positions in the clinical laboratory require a minimum of five years technical experience. It would not be in compliance with the regulations when the clinical laboratory general supervisors are chosen from MLTs or related field, such as cytology or histology or radiology. Healthcare organizations need to assess their lab personnel qualification and competency to assure that they are meeting the standard requirements pursuant to CLIA regulations, state regulations, and accreditation requirements.

If you’d like more information about these regulations, please read the Code of Federal Regulations part 493.

 

Information on policies or practices are solely from my personal experience ONLY and have NO relation to my affiliation with any regulatory or government agency.

satyadi

-Caroline Satyadi, MT(ASCP), SM, DLM, SLS, MBA, MS, CQA (ASQ) has been a laboratory management professional for over 25 years. She has worked with several different medical industries for CLIA/CMS, FDA/ICH/ISO, TJC/CAP/COLA/HFAP accreditation survey readiness.

10 thoughts on “Does Your Laboratory Personnel Meet the CLIA Regulation and Accreditation Requirements?”

  1. Thank you for posting this, it was very informative. I get hung up on “testing” personnel versus “lab” personnel. Would you tell me the difference? My understanding is, for example an HTL qualifies as testing personnel but a histology trainee would then qualify to be lab personnel?
    Thanks, again
    Jennifer

  2. In some instances the terms can be interchangeable: all testing personnel are lab personnel but not all lab personnel are testing personnel. “Lab personnel” includes those employees (such as data entry) that do not test specimens; “testing personnel” are employees that perform the actual testing.

  3. From the Code of Regulations posted Testing personnel for high-complexity can be “(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or” This is an MLT so where are you finding that only MT’s can work in the blood banks for high complexity as you state in your article. The only reason I’m asking is because it is very rare to find a lab that is over 50% MT’s anymore

    1. Matthew, I agree with you. The limitations for MLT’s stated in the article contradict my interpretation of the federal standards and the practice in our CAP-accredited laboratory. The reality is; ‘supply and demand’ does not afford me the opportunity to have all high complexity testing performed by MT’s.

  4. I feel that the testing personnel should be at least overseen by MT’s for the purpose of maintaining a quality standard (ie; MT supervisors). I feel all personnel should maintain some degree of continued education as ASCP requires for “cm”. This allows laboratories to keep with the ever changing laboratory field.

  5. Thank you. I have been saying this our experienced MT are being over looked by are supervisor. He recently just made a MLT with less then 3 years experience the micro supervisor! And hired a fresh out of school MLT grad to work in micro! So now there is only 2 MLT’s in micro! Even though he has 2 MT’ s with years of experience in micro! They were not even offered either position!

  6. Tracy,
    As a retired MLT, I have always resented the assumption that MLTs don’t know what they are doing. It is true they don’t have as extensive a general studies education as the MT/CLS, but they do have 2 years of education concentrated in laboratory technology. I can’t attest to the quality of every MLT program, but mine was excellent, although it would have been better if the amount of time in clinical rotations had been longer.

    Having said that, I agree that an MLT fresh out of school definitely needs to work alongside an experienced Micro tech. There is no reason to assume that the MLT with less than three years experience is not capable of supervising Micro if she/he was well trained. Perhaps that MLT shows better supervisory skills than the more experienced MTs. Not everyone is cut out to be a supervisor no matter what kind of degree they have. Who knows? Maybe it was simply unfair favoritism.

  7. It is unfortunate that demonstrated competency and experience do not factor into this requirement. I am an ASCP-certified MT Hematology section leader, and the two most techs I trust the most for their clinical expertise for both CBC differentials and microbiology/gram stains are both MLTs. They are excellent laboratorians whom I would trust with my life. I cannot say the same for some of the MTs.

  8. I have a question regarding MLTs working in Micro, if anyone will be able to answer. This is pertaining to susceptibility testing for both manual and automated. Since CLIA has regulated this as high complexity testing, are MLTs not allowed to perform any aspects of susceptibility testing, particularly setting up the testing such as picking isolated pure colonies and preparing a 0.5 McFarland, and loading onto an instrument such as Vitek 2 or inoculating a lawn onto a Mueller Hinton plate?

  9. I have a question. I am a MLT/HTL ASCP certified with ten years of experience in general lab and five years in histopathology/cytology. Would my associates degree and certifications qualify me to aspire to a supervisor position in Histology? No histocompatibility or cytogenetics testing is performed in our lab.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s