Clinical Laboratory Improvement Amendments of 1988 ^87 ^639
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) establish quality standards for all nonresearch laboratories, including physician offices that perform tests that examine human specimens for the diagnosis, prevention, or treatment of any disease, impairment of health, or health assessment.
All physician offices that conduct any such tests must be certified by the Secretary of the Department of Health and Human Services. The Centers for Medicare & Medicaid Services (CMS) administers the CLIA laboratory certification program for the Secretary in conjunction with the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention.Most obstetrician-gynecologists’ offices have either certificates of waiver or certificates for provider-performed microscopy (PPM) procedures. This appendix provides more information on these two types of certificates.
Certificates of Waiver
Laboratories, including physician offices, performing only waived tests must obtain a certificate of waiver from CMS in order to perform these tests. No additional complex tests may be performed by the laboratory without prior authorization from CMS. Currently, an extensive list of waived tests (“Tests Granted Waived Status Under CLIA”) exists and can be
obtained on the CMS web site, available at www.cms.gov/clia/downloads/ waivetbl.pdf. This list is revised periodically, and physicians should check with CMS to obtain the current list.
Offices performing only waived tests are exempt from the bulk of CLIA regulatory requirements, including proficiency testing, patient test management, quality control, personnel, quality assurance, and routine inspections. However, physician offices must follow manufacturer’s instructions for performing the test. Physician offices also are subject to random announced or unannounced inspections to determine whether only waived tests are being performed and to collect information about waived tests.
Complaints filed against an office also will be investigated through an inspection.The three CLIA requirements for waived laboratories are 1) enroll in the CLIA program; 2) pay applicable certificate fees biennially ($150); 3) follow the manufacturers’ test instructions. Renewal applications for certificates of waiver must be submitted to the U.S. Department of Health and Human Services no less than 9 months and no more than 12 months before the expiration of the certificate.
Certificate for Provider-Performed Microscopy Procedure
A certificate for PPM procedures is issued to a laboratory that conducts tests that fall under the PPM category. The procedures that are now defined as PPM are as follows:
• Wet mounts, including preparations of vaginal, cervical, or skin specimens
• All potassium hydroxide preparations
• Pinworm examinations
• Fern test
• Postcoital direct, qualitative examinations of vaginal or cervical mucus
• Urinalysis; microscopic only
• Urinalysis, by dipstick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any number of these constituents; nonautomated, with microscopy
• Urinalysis, by dipstick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any number of these constituents; automated, with microscopy (Note: May only be used when the laboratory is using an automated dipstick urinalysis instrument approved as waived.)
• Urinalysis; two or three glass test
• Fecal leukocyte examination
• Semen analysis; presence and/or motility of sperm excluding Huhner
• Nasal smears for eosinophils
A PPM certificate also permits laboratories to perform waived tests but not other tests of moderate or high complexity. Before performing any other tests in the waived or PPM lists, a laboratory must obtain a registration certificate to cover the additional tests of greater complexity.
A laboratory with a PPM certificate also must have a laboratory director, and, if required by state law, the director must possess a state laboratory director license. The laboratory director must be a physician or a midlevel practitioner authorized to practice independently in the state where the laboratory is located. A midlevel practitioner is defined as a nursemidwife, nurse practitioner, or physician assistant licensed by the state within which the individual practices, if such licensing is required in the state in which the laboratory is located.
The regulations also require that the microscopic tests be personally performed by a physician, a midlevel practitioner under a physician’s supervision, or a midlevel practitioner in independent practice, if authorized by the state. To qualify under the PPM category, the procedure also must occur during the patient’s visit on a specimen obtained from the practitioner’s own patient or from a patient of the group medical practice, clinic, or other health care practitioner where the physician or midlevel practitioner is a member or an employee.
Laboratories with a PPM certificate do receive significant relief from two of the CLIA regulatory requirements. They are not subject to routine inspections, and the cost of the certificates, $200, is significantly less than the cost of a certificate for a laboratory performing tests of greater complexity. Announced or unannounced inspections may be conducted, however, to determine laboratory compliance in performing only the PPM or waived procedures listed, to evaluate complaints, and to collect data on microscopy procedures.
Other Clinical Laboratory Improvement Amendments Requirements
Laboratories with a PPM certificate also must comply with the proficiency testing, patient test management, quality control, and quality assurance requirements of the CLIA for laboratories performing tests of moderate complexity:
• Generally, the regulations prescribe that each laboratory must enroll in a proficiency testing program.
At this time, none of the tests in the PPM category are required to fulfill the proficiency testing requirements. Laboratories with PPM certificates are still required, however, to meet the CLIA quality assurance requirements. Basically, this requires a laboratory to verify the accuracy, at least twice a year, of any test not subject to proficiency testing. This can be accomplished in a number of ways, including splitting specimens with a reference laboratory, evaluating the patient’s clinical picture, or enrolling in a non-CLIA-approved proficiency testing program that does proficiency testing for PPM procedures.• Patient test management requirements state that each laboratory must have available and follow written policy and procedures for specimen submission and handling. A written procedure manual also must be available and followed by office personnel for quality control purposes.
Certificates for PPM are valid for up to 2 years. To renew a PPM certificate, the appropriate renewal paperwork must be returned to the U.S. Department of Health and Human Services 9-12 months before the expiration of the certificate.
Information about CLIA is available at the CMS web site: www.cms.gov. Information on how to apply for a CLIA certificate is available from local state survey agencies. A listing of state survey agency contacts is available on the CMS web site.