Understanding CLIA – Part Three

The regulations are very specific when it comes to the personnel requirements. Every laboratory performing moderate and high complexity test must have a laboratory director.  The director “must be qualified to manage and direct the laboratory personnel and performance of high complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R (enforcement and procedure).”

Laboratory Director Qualifications

A laboratory director must –

  • Be an MD/CO licensed to practice medicine board certified in anatomic or clinical pathology
  • Be an MD/DO licensed to practice medicine and
    • Have at least one year of laboratory training during medical residency or
    • Have at least 2 years of experience directing or supervising high complexity testing
  • Have earned a doctoral degree in chemical, physical, biological or clinical laboratory science and
    • Be certified by a board approved by HHS or
    • Before February 24, 2003 must have served as a director of a laboratory performing high complexity testing and must have at least
      • Two years of laboratory training or experience and
      • Two years of laboratory experience directing and supervising high complexity testing

Laboratory Director Duties and Responsibilities

The laboratory director is responsible for everything that happens in the lab.  They are responsible for overall operations and administration which include hiring competent technologists, approval of testing protocols and procedures, test reporting, and assuring compliance with applicable regulations.  The laboratory director may reapportion performance of responsibilities to others but remains responsible that those duties are performed properly.

Responsibilities include

  • Ensure that there is a quality management system for all the aspects involved in the testing of samples which include pre-analytic, analytical and post-analytic
  • Ensure the proper physical and environmental conditions are appropriate for the testing performed
  • Ensures that –  
    • The test methodologies selected have the capability of providing the quality of results required for patient care
    • Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and
    • Laboratory personnel are performing the test methods as required for accurate and reliable results
  • Ensure that the laboratory is enrolled in a proficiency testing program for the testing performed and that—
    • The proficiency testing samples are tested as required under subpart H of this part
    • The results are returned within the time frames established by the proficiency testing program
    • All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory’s performance and to identify any problems that require corrective action and
    •  An approved corrective action plan is followed when any proficiency testing result is found to be unacceptable or unsatisfactory
  • Ensures a quality control and assessment program are established and maintained
  • Ensures the establishment of acceptable levels of analytical performance of each test being performed
  • Ensures that there are systems in place to detect, correct and document errors
  • Available for consultation with clients
  • Supervisor is qualified to provide on-site supervision and that all employees are properly trained prior to performing tests, and that the laboratory has sufficient personnel to perform all the testing
  • Ensures that the approved procedure manual is easily accessible to all employees.

The laboratory director may also serve as the laboratory’s technical supervisor and clinical consultant.  There are several requirements and responsibilities for each of these positions should your laboratory be placing individuals other than your laboratory director in these positions. The technical supervisor and clinical consultant must have an advanced degree and qualify as a laboratory director in order to hold these positions. 

Laboratory Supervisor Qualifications

Depending on the size of the laboratory, the laboratory director may also serve a supervisor.  To qualify as a supervisor, the individual must

  • Have earned a doctoral degree and has at least 2 years of experience post-graduation or
  • Holds a master’s degree with at least 4 years of experience post-graduations or
  • After qualifying as a laboratory technologist, has at least 6 years full time laboratory experience with at least 2 years’ experience in the current sub specialty.

Laboratory Supervisor Responsibilities

  • Responsible for the day-to-day supervision of oversight of the laboratory operation
  • Must be accessible to testing personnel at all time either by phone or through electronic consultation
  • Daily quality assurance of test analysis
  • The director or technical supervisor may delegate the following to the supervisor
    • Corrective actions
    • Reviewing that all test results are correct prior to reporting
    • Orientation to all testing personnel
    • Annual evaluations and documentation of testing personnel performance

Testing Personnel Qualifications

Testing personnel must have a bachelor’s degree in a chemical, physical, biological or clinical laboratory science.  There are several institutions offering clinical laboratory training program degrees.  An associate’s degree can be considered if the following conditions are met –

  • At least 60 semester hours which include either
    • 24 semester hours of medical laboratory technology courses or
    • 24 semester hours of science courses that include 6 hours of chemistry, 6 hours of biology and 12 hours of chemistry, biology or medical technology combination and laboratory training

Next week we will discuss the consequences for failure to comply with any one of the CLIA regulations.