Testing Tips

Testing Tips for Waived and PPM Laboratories

Test Your Knowledge of Waived and PPM Labs

True or False?

1. Quality control is never required on waived tests.
2. Once the testing personnel review the manufacturer's instructions for a test, it is not necessary to review them again.
3. Documented training is not required of testing personnel in a waived lab.
4. A waived lab can perform CBCs if the test is not billed.
5. Quality assurance is not required for PPM labs.

The correct answer to all of these questions is false. Being a CLIA waived or provider performed microscopy (PPM) lab does not mean there aren't specific regulatory criteria for the physician office laboratory (POL) to adhere to.

Under the CLIA regulations, POLs with a certificate of waiver (COW) may perform only those tests that have been classified as waived. POLs with a PPM certificate may perform tests, using a microscope, during the course of a patient visit on specimens that are not easily transportable, along with the waived tests.

Waived labs are required by CLIA to:

• Enroll in the CLIA program
• Pay applicable certificate fees biennially
• Follow manufacturers' test instructions

The number and types of tests waived under CLIA have increased from eight tests to approximately 40 since the inception of the program in 1992. As a result, the number of waived labs has grown exponentially from the total 171,000 laboratories enrolled.

PPM labs are required by CLIA to:

• Enroll in the CLIA program
• Pay applicable certificate fees biennially
• Address certain quality and administrative requirements

Checklist for Waived/PPM Testing Compliance

Waived Labs:

• Use the most recent package insert of manufacturer's instructions. Kit instructions may change slightly from lot to lot; date the insert with the date the shipment was received as documentation.
• Perform quality control and/or calibration as specified by the kit manufacturer– most of the test kits receiving waived status after the publication of the CLIA 88 regulations have specific quality control requirements. Maintain the quality control documentation for two years.
• Use the test kits/reagents in the form they are received; do not alter reagent strips by cutting them in order to test more samples per strip.
• Store and handle all test kits according the manufacturer's instructions.
• Never use outdated reagents.
• Document training of all testing personnel in their personnel file– training for each test and test method is required. Update the training records whenever a test method changes (either the method or the manufacturer).
• Inform the POLs surveying agency of any change in status of the lab (e.g., change in the medical director, practice name, address, etc.). Monitor room and refrigerator temperatures.
• Follow all OSHA regulations that pertain to laboratory testing (e.g., Bloodborne Pathogens regulations).
  

PPM Labs (in addition to the checklist for waived testing):

• Perform either proficiency testing or quality assurance (i.e., split sampling or an external quality assurance program) at least two times per year for documentation of accuracy of the procedures.
• Perform and document microscope and centrifuge maintenance (daily, or when tests are performed).
• Develop and maintain a current procedure manual for all microscopy tests performed in the lab.
• Perform and document personnel competency (through quality assurance testing or other educational material for microscopy testing).
• Inform the POLs surveying agency of any change in status of the lab (e.g., change in the medical director, practice name, address, etc.).
• Follow all OSHA regulations that pertain to laboratory testing (e.g., Bloodborne Pathogens regulations).