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Waived tests are defined to employ methodologies so simple and accurate as to render the likelihood of erroneous results is very low when manufacturer procedure is followed. However, with the advancement of technologies, tests that are FDA approved for waived or home testing, does not mean waived tests are completely error-proof. They pose no reasonable risk of harm to the patient if the test is performed incorrectly, and they are cleared by the Food and Drug Administration for home use. Errors can occur anywhere in the testing process, particularly when the manufacturer’s instructions are not followed and when testing personnel are not familiar with all aspects of the test system.
Some waived tests have potential for serious health impacts if performed incorrectly. For example, results from waived tests can be used to adjust medication dosages, such as prothrombin time testing in patients undergoing anticoagulant therapy and glucose monitoring in diabetics. In addition, erroneous results from diagnostic tests, such as those for human immunodeficiency virus (HIV) antibody, can have unintended consequences. To decrease the risk of erroneous results, the test needs to be performed correctly, by trained personnel and in an environment where good laboratory practices are followed.
Offices wanting only to perform waived tests must apply for a certificate of waiver (COW).
Provider-performed microscopy (PPM) procedures are a select group of moderately complex microscopy tests commonly performed by licensed health care providers during patient office visits. Tests included in PPM procedures do not meet the criteria for waiver because they are not simple procedures; they require training and specific skills for test performance. A CLIA Certificate for PPM procedures allows physicians, midlevel practitioners (i.e., nurse practitioners, nurse midwives, and physician assistants) and dentists to perform certain moderate complexity microscopic examinations in addition to waived testing during a patient’s visit.
The laboratory or testing site performing PPM procedures is not subject to routine biennial inspections. However, a CLIA certificate is required, and the laboratory or testing site must meet the CLIA quality standards for moderate complexity testing.
Sites performing PPM procedures must file for a Certificate for PPM procedures and obtain a separate certificate for each location.
Other key notes about PPM:
A. Allowed microscopic exams using bright field or phase-contrast microscopy:
B. The specimens for these procedures deteriorate quickly or delay in performing the test could compromise the accuracy of the test result, therefore recommended to be performed during the course of the patient visit.
C. Quality control is required when it is available; control material is available for urine sediments.
D. PPM tests are considered non-regulated, proficiency testing (PT) is not specifically required, but a laboratory is responsible for documenting quality assurance. For more guidance read the PPM: A Focus on Quality Practices booklet authored by CDC.
E. Several CLIA-approved PT programs offer modules for PPM and participation in a clinical microscopy or PPM PT module will satisfy the bi-annual alternative competency assessment requirement. If laboratories or testing sites enroll in PT, they are subject to all requirements for PT including the prohibition of PT referral.
F. Those laboratories with an inspecting agency other than CMS/state agencies should contact their inspecting agencies to inquire about their specific requirements.
G. The 42 CFR 493- October 2001 indicates that PPM laboratories are subject to Subparts H (Proficiency Testing), J (Patient test Management), K (Quality Control), M (Personnel), and P (Quality Assurance).