The correct answer to all of these questions is "False." Being a CLIA waived or PPM lab does not mean that there are no specific regulatory criteria for the 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 Provider Performed Microscopy (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:
Tips on Waived Testing
Test Your Knowledge of Waived and PPM Labs:
True or False
- Quality control is never required on waived tests.
- Once the testing personnel review the manufacturer's instructions for a test, it is not necessary to review them again.
- Documented training is not required of testing personnel in a waived lab.
- A waived lab can perform CBCs if the test is not billed.
- Quality assurance is not required for PPM labs.
- 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 8 tests to approximately 40 since the inception of the program in 1992; as a result, the number of waived labs has grown exponentially from 20% to 54% of the total 171,000 laboratories enrolled.
PPM labs are required by CLIA to:
PPM labs are required by CLIA to:
- Enroll in the CLIA program
- Pay applicable certificate fees biennially
- Address certain quality and administrative requirements
PPM labs represent 22% of the laboratories in the United States; consequently, 76% of the labs have no direct routine oversight (inspections or surveys). The regulations do provide for inspections of waived and PPM labs in certain situations.
Pilot Studies
In 1999, the states of Colorado and Ohio initiated on-site inspections of a random sample of CLIA waived and PPM labs as a result of the increases in the types of tests waived, the large number of labs with no oversight and the CLIA defined deficiencies found during complaint investigations of these waived labs. CMS reported that significant quality and certification problems were identified in over 50% of the inspected labs. If quality problems were found, the inspectors provided educational support to the labs to help them ensure accurate results. The study further showed that 10% of the labs in Ohio and 7% of the labs in Colorado were testing beyond their certificate. Between October 2000 and January 2001 CMS expanded the pilot to include eight additional states throughout the US in order to follow-up and verify the scope and seriousness of the initial findings, The states included Arizona, Idaho, Iowa, Massachusetts, Mississippi, New Mexico, New York, and Pennsylvania. Using Colorado and Ohio's pilot as a model, CMS inspected 2.5% (or 436) of waived and PPM labs in the selected states. The quality problems found under the expanded October 2000 through January 2001 survey process were:
Problems in Waived Laboratories
32% failed to have current manufacturer's instructions
32% did not perform QC as required by manufacturer or CDC
20% cut occult blood cards and urine dipsticks
19% had personnel who were neither trained nor evaluated
16% failed to follow current manufacturer's instructions
9% did not follow manufacturer's storage and handling instructions
7% did not perform calibration as required by manufacturer
6% were using expired reagents/kits
23% had certificate issues (i.e., change of name, director or address)
It is worth noting that 21% of the inspected waived labs voluntarily participate in proficiency testing and/or performed QC beyond the manufacturer's instructions. Additionally, none of the labs were found to be operating in a manner that posed immediate jeopardy.
32% did not perform QC as required by manufacturer or CDC
20% cut occult blood cards and urine dipsticks
19% had personnel who were neither trained nor evaluated
16% failed to follow current manufacturer's instructions
9% did not follow manufacturer's storage and handling instructions
7% did not perform calibration as required by manufacturer
6% were using expired reagents/kits
23% had certificate issues (i.e., change of name, director or address)
It is worth noting that 21% of the inspected waived labs voluntarily participate in proficiency testing and/or performed QC beyond the manufacturer's instructions. Additionally, none of the labs were found to be operating in a manner that posed immediate jeopardy.
Problems in PPM Labs
38% had no PT (did not evaluate test accuracy 2 times a year)
36% had no microscope/centrifuge maintenance
28% no director approved procedure manual
25% did not document personnel competency (QA)
23% had certificate issues
36% had no microscope/centrifuge maintenance
28% no director approved procedure manual
25% did not document personnel competency (QA)
23% had certificate issues
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 QC 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). See http://www.osha-slc.gov/dts/oom/bbp.html for additional information.
PPM Labs:
(in addition to the checklist for Waived testing)
- Perform either proficiency testing or quality assurance (i.e., split sampling or an external QA 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).
