First, determine which tests will be performed in your practice and if these tests are categorized as CLIA waived or non-waived tests. If the laboratory will perform Non-waived testing, the Laboratory Director must meet qualifications. Then, you submit the CLIA application (Form-116) which is available online at the CMS CLIA website. Forward the completed application to the address of the local State Agency.

Download application and instructions for completion.

Qualifications for a Laboratory Director for Moderate Complexity Testing
(Education, Training and Experience)

• M.D., D.O. with current medical license in state of laboratory's location and certified in anatomic and/or clinical pathology by APB or AOBP or equivalent qualifications or
• M.D., D.O. with current medical license in state of laboratory's location and laboratory training/experience consisting of: 1 year directing or supervising nonwaived testing or 20 CME credit hours in laboratory practice commensurate with director responsibilities.
• (Effective 08/02/93) or equivalent laboratory training (20 CMEs) obtained during medical residency or
• Doctorate in Chemical, Physical, Biological or Clinical Laboratory Science and certification by ABMM, ABCC, ABB, ABMLI or
• Masters in Clinical Laboratory Science, Medical Technology or Chemical, Physical, or Biological Science and 1 year laboratory training/experience and 2 years supervisory experience in a laboratory or
  
• Bachelors in Medical Technology, or Chemical, Physical, or Biological Science and 2 years laboratory training/experience and 2 years supervisory experience in a laboratory or
  
• On or before 02/28/92 qualified or could have qualified as a director under the Laboratory Regulations published March 14, 1990 or
• On or before 02/28/92 qualified as a director by the state in which the laboratory is located.
  

1. Determine your patient's needs and assess the laboratory's test menu and the selection of test methodologies; taking into consideration level of complexity of tests, cost effectiveness and test volume before implementation of new systems.

2. Ensure that the Laboratory has a qualified Laboratory Director that will be responsible for the overall operation and administration of the laboratory. If Laboratory Director is not qualified he/she can complete a 20 CME course for Laboratory Directors of Moderately Complexity laboratories to fulfill Lab Director requirements and meet CLIA guidelines.
   

3. Apply for a CLIA certificate by completing and submitting the CLIA application (Form-116).
   

4. Enroll in Proficiency Testing for all tests requiring PT enrollment (test with non-waived status).
   

5. Perform validation of new methods that have non-waived status; accuracy, precision, and reportable range.
   

6. Establish and implement a procedure manual.
   

7. Establish and implement quality control and quality assurance programs.
   

8. Specify in writing the responsibilities and duties of each testing person, ensuring all testing personnel are competent.
   

9. The Laboratory must have a record system; Temperature logs, maintenance logs, master logs, specimen referral logs, reagent logs, action logs, communication logs, QC logs and patient test result logs.
   

10. Follow CLIA guidelines and good Laboratory Practices.
    

As defined by CLIA, waived tests are categorized as simple laboratory examinations and procedures that have an insignificant risk of an erroneous result. The Food and Drug Administration (FDA) determines the criteria for tests being simple with a low risk of error and approves manufacturer's applications for test system waiver.

Calibration Verification is the testing of materials of known concentration in the same manner as patient specimens to assure the test system is accurately measuring samples throughout the reportable range, checking the calibration.

Calibration verification is to be performed for nonwaived (moderate and high complexity) tests. It must be performed every 6 months (or more frequently if specified in the test system's instructions) and whenever any of the following occur:

• Change of reagents to new lot numbers, unless laboratory can demonstrate differently.

• Major preventive maintenance or replacement of critical parts that may influence the test performance.
  

• Control materials reflect unusual trends or shifts, or are outside the laboratory's acceptable limits, and other means of corrective action fail to identify and correct the problem.
  

• The Laboratory determines that the system's reportable range for patient test results should be checked more frequently.
  

Eligibility for an Equivalent Quality Control placement requires consideration of test system criteria, manufacturer's instructions, and excluded methods. Refer to CLIA (Equivalent Control Procedures) Brochure #4, for EQC options and Criteria.

You must verify that the test's performance in your laboratory is similar to the manufacturer's claims of accuracy, precision and reportable range. All related forms, printouts, control inserts, and reports will be maintained for the life of the system plus 2 years.

• Accuracy is determined by performing a multiple-point linearity study.

  Linearity study must meet the minimum standards:

  Slope = 1.0 +/- 15% (0.85 - 1.15)

  R² > 0.95
  

• Precision is determined by evaluating 15 level 1 or normal control results.

  Precision study must meet the minimum standards:

  Control mean +/- 2SD

  CV < 2.0% or as otherwise noted on the worksheet.
  

• Reportable Range is determined by demonstrating accuracy at a low, mid, and high point. Use data from Linearity Study.
  

• Verification of manufacturer's normal values is determined by comparing 5 non-patient results against the manufacturer's normal values.