A laboratory must meet the CLIA regulatory requirements for enrollment, participation, and testing specified in Subpart H - Proficiency Testing by Specialty and Subspecialty for Laboratories Performing Tests of Moderate Complexity (Including the Subcategory), High Complexity, or Any Combination of These Tests.

Subpart H specifies requirements for the following:

  • Enrollment in a CMS approved PT program
  • Testing of the PT samples
  • PT sample handling 
  • Documentation retention of PT records

A list of CLIA-approved proficiency testing programs can be found at the CMS website.

Using the list on the CLIA website, choose one (or more if your director wishes) of the approved PT programs that offer the testing you perform in your laboratory. The PT program can assist you with proper enrollment, as this is a CLIA requirement for approved PT programs. The program will notify CMS of your enrollment and the PT testing you have signed up to perform. You will also need to add the State Agency (NYS DOH) to their notification list.

PT samples must be tested in the same manner you test patient specimens. This means: 

  • Testing the PT samples the same number of times as patient specimens
  • At the same time as patient specimens
  • By the same personnel that routinely test the patient specimens
  • Using the same test system that is routinely used for the patient specimens

PT samples must be rotated among the testing personnel that perform the testing in your laboratory. Please note that some PT sample preparation may be necessary before testing. In other words, after preparation, PT samples must be treated in the same manner as patient specimens. However, never send PT samples out of your laboratory for any reason, even if you routinely send out patient specimens for additional or confirmatory testing.

Never discuss your PT results with another laboratory nor their PT results before the PT event cut-off date. This activity may cause you to lose your CLIA certificate

Never send your PT samples to another laboratory even if you send your patient specimens to another laboratory for confirmation or identification testing.

Sending PT samples to another laboratory for testing is considered PT referral and will result in serious actions being taken against your laboratory, your laboratory director, and the laboratory owner. The penalties may include, but not limited to, loss of your laboratory’s CLIA certificate for at least one year, the director being prohibited from directorship of a laboratory for two years, and the laboratory owner being prohibited from owning or operating a laboratory for two years. Your laboratory’s name will be listed on the CMS Laboratory Registry on the CMS web site. Be extremely cautious not to send PT samples out for a “reflex” test.

You must keep a copy of all your records, such as: 

  • The step-by-step PT sample preparation and handling
  • All the steps taken in the testing of the sample
  • A copy of the PT program results form used to record and submit your PT results (includes the attestation statement)
  • A print screen if results are entered electronically
  • The PT program’s evaluation of your laboratory’s performance, etc.

Please note: Submission forms, results forms, corrective action forms must be signed by the testing staff and laboratory director.

These copies must be maintained for a minimum of two years from the date of the PT event. If any corrective actions are taken as a result of an unacceptable score, maintain records of these actions for two years also.