Federal authority over clinical laboratories began in 1966 when Medicare independent-laboratory regulations established personnel standards for laboratories that participated in the Medicare and Medicaid programs. The following year, Congress enacted the Clinical Laboratory Improvement Act of 1967, known as ‘tCLIA ‘67,” which required licensure for laboratories testing patients’ specimens in in...

The validation of diagnostic methods (and the subsequent results generated by a laboratory) are improved through participation in inter-laboratory comparisons (IC), such as proficiency-testing (PT) programmes and other exercises referred to ‘ring tests’ or trials’ (RTs). This is requirement comply with international quality standards. Validating method continuous process taking part ongoing PT ...

In December 1987, the Centers for Disease Control (CDC) proposed to the Health Care Financing Administration revised criteria for evaluating participating laboratories' performance in proficiency-testing programs. If these criteria are accepted, they will become the minimum standard for all regulatory proficiency-testing programs. To evaluate a laboratory's performance in a clinical chemistry p...

Under the Clinical Laboratory Improvement Act of 1967 the Health Care Financing Administration's proficiency-testing requirement applies to approximately 12,000 hospital, reference, and large-clinic laboratories in the United States. The Wisconsin State Laboratory of Hygiene is approved by the Health Care Financing Administration to provide proficiency testing in all specialties and subspecialt...

These suggestions are as follows: 1) Regular use of certified reference materials and/or internal quality control using secondary reference materials 2) Participation in interlaboratory comparison or proficiency testing programs 3) Replicate tests or calibrations using the same or different methods 4) Retesting or recalibration of retained items 5) Correlation of results for different character...

OBJECTIVE To measure the impact of an objective evaluation of provider Spanish-language skills on self-reported language proficiency and comfort using Spanish in a range of clinical scenarios. METHODS We enrolled pediatric residents with any self-reported Spanish language ability from 3 residency programs. Participants completed a baseline survey, objective language testing, and a posttest su...