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BACKGROUND AND HISTORY
Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988. CLIA requires all laboratories that examine materials derived from the human body for diagnosis, prevention, or treatment purposes to be certified by the Secretary of Health and Human Services. The Centers for Medicare and Medicaid Services (CMS) administers CLIA laboratory certification program for the Secretary in conjunction with the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). CMS considers CLIA one of its most important programs.

For many Americans, the accuracy of clinical laboratory test results can be a life or death matter. For instance, if a clinical laboratory misreads a patient's blood sample as having a normal cholesterol level, when in fact it is high in cholesterol, that patient may not receive the treatment needed to prevent a heart attack. It is also important to note that even though waived tests are deemed simple to perform, erroneous results are possible and can produce untoward patient outcomes if acted upon. For example, glucose tests performed on a meter approved by FDA for home use are waived under CLIA and can be done at any site by any person. Thus, in a point of care setting such as a skilled nursing facility (SNF), these test results can be utilized to monitor a patient's treatment to determine their next dose of insulin. If the SNF does not train their testing personnel to follow the manufacturer's instructions, to control and maintain the device appropriately, and to read the test results within the specified time frame, a patient could receive an incorrect insulin dose and sustain potentially dangerous consequences.

WAIVED AND PROVIDER PERFORMED MICROSCOPY (PPMP) TESTS
By the CLIA law, waived laboratories perform only tests that are determined by FDA or CDC to be so simple that there is little risk of error. Laboratories with a PPMP certificate perform tests, using a microscope, during the course of a patient visit on specimens that are not easily transportable.

Waived laboratories must meet only the following requirements under CLIA:

• Enroll in the CLIA program;
• Pay applicable certificate fees biennially; and
• 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; thereby, the number of waived laboratories has grown exponentially from 20% to 56% of the total 174,500 laboratories enrolled.

PPMP laboratories must meet only the following requirements under CLIA:

• Enroll in the CLIA program;
• Pay applicable certificate fees biennially; and
• Certain quality and administrative requirements.

PPMP laboratories represent 22% of the laboratories in the country; thus, 78% of the laboratories have no direct routine oversight. The regulations, however, do provide for inspections of waived and PPMP laboratories under certain circumstances.

1999 PILOT STUDY
Due to the increases in the types of tests waived, the large number of laboratories with no oversight, and the serious findings in complaint investigations of these waived laboratories, the States of Colorado and Ohio initiated on-site inspections of a random sample of CLIA waived and PPMP laboratories. These pilots consisted of focused on-site inspections (Ohio did 100, Colorado did 95) with prior notification and screening of the laboratory to confirm whether the State's concerns about quality problems were correct. Significant quality and certification problems were identified in over 50% of these laboratories. If quality problems were found, the inspectors provided assistance to the laboratories to achieve accurate results. Ohio found 10 % and Colorado found 7% of the laboratories inspected to be testing beyond their certificate. These laboratories were performing moderate complexity tests and, if properly enrolled in CLIA, would be subject to biennial inspections and higher fees.

EXPANSION OF PILOT STUDY -- (OCTOBER 2000 THROUGH JANUARY 2001)
To follow-up and verify the scope and seriousness of these initial findings, CMS expanded this pilot to include 8 additional States across the nation. These states were 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 PPMP laboratories in the 8 selected States. The findings of the Pilot Project Final Report are detailed below. (PDF 450K)

Project Findings
Information gathered during this project is separated into waived and PPMP categories. The surveyors collected information on personnel performing waived testing. The four major categories of personnel performing waived testing were Registered Nurses (RNs), Physicians (M.D./D.O.s), Licensed Practical Nurses (LPNs) and Medical Assistants (Certified M.A.s). There were very few Medical Technologists (MTs) or Medical Laboratory Technicians (MLTs) involved in the performance of waived testing. The quality and certificate problems found under the expanded October 2000 through January 2001 survey process are listed below.

Quality Problems in Waived Laboratories
- 32 % failed to have current manufacturer's instructions;
- 32% did not perform QC as required by manufacturer or CDC;
- 16% failed to follow current manufacturer's instructions; and
- 7% did not perform calibration as required by manufacturer.

Additional Quality Problems in Waived Laboratories
- 23% had certificate issues (i.e., change of name, director or address);
- 20% cut occult blood cards and urine dipsticks;
- 19% had personnel who were neither trained nor evaluated;
- 9% did not follow manufacturer's storage and handling instructions; and
- 6% were using expired reagents/kits.

Quality Problems in PPMP Laboratories
- 38% had no PT (did not evaluate test accuracy 2 times a year);
- 36% had no microscope/centrifuge maintenance;
- 28% no director approved SOPM;
- 25% did not document personnel competency (QA); and
- 23% had certificate issues.

Post-Survey Questionnaire Results
All laboratories had the opportunity to evaluate their survey experiences on a confidential post-survey questionnaire (Form HCFA-668B). According to post-survey questionnaires, the project was truly an educational experience for the laboratories. The following are some of the actual comments provided by laboratory participants in the project:
- "Appreciated educational consultative approach; true quality improvement;"
- "Valuable in terms of assuring good performance;"
- "Properly timed, educational, relaxed mood;"
- "Good idea;"
- "Conducted in an exchange of information mode rather than punitive;"
- "Appreciated the chance to participate;" and
- "Strongly support any survey process that improves quality of care to patients."

Revisit Results
These results may be viewed in the Pilot Project Final Report. (PDF 450K)

Current Activities
Starting in April 2002, CMS will be initiating on-site visits to approximately 2 percent of COW laboratories as a result of the significant quality findings in the above mentioned studies. These visits will continue to be announced, information gathering and educational. Information about these visits was sent to the laboratory community, including State survey directors and medical and professional organizations. The information included: a FACT sheet (PDF 82K), CLIA background information (PDF 91K), a letter of intent (PDF 87K), the letter sent to the participating laboratories (PDF 39K), the questions the surveyor uses (PDF 73K) during the visit, and a Good Laboratory Practices (PDF 36K) document that will be left at the laboratory. Preliminary follow-up data from the expanded pilot study indicates that the education provided during these on-site visits is effective. Additionally, CMS is compiling information about existing COW laboratory education programs (PDF 14K) and vehicles to obtain education. By working together with the laboratory professional and educational community, we will ensure that COW laboratories can receive the education needed to achieve accurate and reliable test results, and ultimately improve the quality of health care.

Contacts: Email: Daralyn Hassan (dhassan1@cms.hhs.gov), Ronalda Leneau (rleneau@cms.hhs.gov), Peggy Martin (pmartin3@cms.hhs.gov) or Kate Kremann (kkremann@cms.hhs.gov).