Clinical Laboratory Improvement Act (CLIA)

Preparing for Your CLIA Survey

Background
The Clinical Laboratory Improvement Act regulates all testing used for diagnosis or treatment of human beings. It does not regulate forensic testing such as drug tests used for pre-employment or breath-based testing of alcohol.

Surveys are conducted every 2 years for laboratories performing non-waived tests. Recertification surveys are scheduled within 6 months of the current expiration date. Initial surveys are scheduled 6-12 months after the CLIA certificate is issued. Routine surveys are announced 2-14 days before the survey date. Complaint investigations and follow-up/revisit surveys are always unannounced.

Before the survey: the Pre-Survey Packet
A pre-survey packet should be sent via fax, email, or regular mail. Your pre-survey packet will include: CMS Personnel Report Form 209, Annual Test Volume Form, and Ownership Form. All forms should be completed and signed prior to the survey date.

CMS Personnel Report Form 209

1. Laboratories performing moderately complex testing must list who performs the following functions in the laboratory;
   1. Laboratory Director (LD)
   2. Clinical Consultant (CC); must be an MD, DO or DPM
   3. Technical Consultant (TC)
   4. Testing Personnel (TP)


2. Laboratories performing high complexity tests must list who performs the following functions in the laboratory;
   1. Laboratory Director (LD)
   2. Clinical Consultant (CC); must be an MD, DO or DPM
   3. Technical Supervisor (TS) for each specialty (e.g. hematology, chemistry)
   4. General Supervisor (GS)
   5. Testing Personnel (TP)

Annual Test Volume Form
List all tests performed in the laboratory. Do not list tests sent out to a reference laboratory. CLIA requires that all panels are broken down into individual measured tests for counting. For example, a CBC breaks down to: WBC, RBC, HGB, HCT, PLT, & DIFF. So 1 CBC = 6 tests for CLIA purposes. Calculated results are not included. Please be as accurate as possible since the survey fees are based on the annual test volume.

Although waived tests are not included in the final total, please include that information on the form.

Ownership Form

This form replaces the HCFA form 1513, Statement of Ownership & Control until CMS approves a new form. Since the majority of correspondence is conducted via email or fax, please provide this information.

What documents must be available for the surveyor?

1. All records related to the laboratory must be maintained at least 2 years including but not limited to quality control, maintenance, temperature monitoring, and any quality assurance activities.
2. If the laboratory does not maintain copies of patient results in the laboratory, access to patient medical records is absolutely necessary.
3. Validation/verification studies of new test systems should be maintained by the laboratory as long as the test system is used.
4. Proficiency testing records including the instrument printouts, submission forms, attestation sheets, scores, and corrective actions must be maintained by the laboratory for at least 2 years.
5. Documentation of testing personnel qualifications including diplomas, transcripts, or DD214 must be maintained by the laboratory. State licenses are not an acceptable form of documentation with the exception of MDs, DPMs, or DOs.
6. Documentation of training for each testing person must be available. A job description is not acceptable since all testing personnel may not perform the same testing.
7. The laboratory director must ensure that there is documentation of annual evaluations for each testing person. This evaluation must include observation and record review. Proficiency testing events can be used as part of the evaluation.
8. New testing personnel must be evaluated within 6 months of hire in the laboratory.
9. Shipping and other records may be required by the surveyor if a problem is identified.

For a complete listing of CLIA requirements, go to www.cms.hhs.gov/clia to review the interpretive guidelines and regulations.

New Mexico Division of Health Improvement

To Make a Complaint by Phone,
Call the Department of Health's Incident Management Bureau at 1(800) 445-6242
or
The Health Facility Licensing & Certification Bureau at 1 (800) 752-8649