Good laboratory practices for waived testing sites: survey findings from testing sites holding a certificate of waiver under the clinical laboratory improvement amendments of 1988 and recommendations for promoting quality testing.

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), simple, low-risk tests can be waived and performed with no routine regulatory oversight in physicians' offices and various other locations. Since CLIA was implemented, waived testing has steadily increased in the United States. Surveys conducted during 1999-2004 by the Centers for Medicare & Medicaid Services and studies funded by CDC during 1999-2003 evaluated testing practices in sites holding a CLIA Certificate of Waiver (CW). Although study findings indicate CW sites generally take measures to perform testing correctly, they raise quality concerns about practices that could lead to errors in testing and poor patient outcomes. These issues are probably caused, in part, by high personnel turnover rates, lack of understanding about good laboratory practices, and inadequate training. This report summarizes study findings and provides recommendations developed by the Clinical Laboratory Improvement Advisory Committee for conducting quality waived testing. These recommendations include considerations before introducing waived testing, such as management responsibility for testing, regulatory requirements, safety, physical and environmental requirements, benefits and costs, staffing, and documentation. They also cover good laboratory practices for the three phases of testing: 1) before testing (test ordering and specimen collection), 2) during testing (control testing, test performance, and result interpretation and recording), and 3) after testing (result reporting, documentation, confirmatory testing, and biohazard waste disposal). They are intended to be used by those who would benefit from improving their knowledge of good laboratory practices. Continued monitoring of waived testing, with a focus on personnel education and training, is needed to improve practices and enhance patient safety as waived testing continues to increase.

Comparison of routine glove use and contact-isolation precautions to prevent transmission of multidrug-resistant bacteria in a long-term care facility.

OBJECTIVES: To compare routine glove use by healthcare workers for all residents, without use of contact-isolation precautions, with contact-isolation precautions for the care of residents who had vancomycin-resistant enterococci or methicillin-resistant Staphylococcus aureus isolated from a clinical culture. DESIGN: Random allocation of two similar sections of the skilled-care unit to one of the infection-control strategies during an 18-month study period. SETTING: Skilled-care unit of a 667-bed acute- and long-term care facility. PARTICIPANTS: All residents present or admitted to the skilled-care unit from June 1, 1998, through December 7, 1999. MEASUREMENTS: Resident acquisition of four antimicrobial-resistant organisms (methicillin-resistant Staphylococcus aureus, vancomycin-resistant enterococci, or extended-spectrum beta-lactamase-producing Klebsiella pneumoniae or Escherichia coli). All isolates were strain typed. The facility level costs associated with each strategy were estimated. RESULTS: Resident acquisition of antimicrobial-resistant organisms was no different in the glove-use and isolation-precautions sections (31 episodes (1.5 per 1,000 resident-days) vs 38 episodes (1.6 per 1,000 resident-days)). Acquisition of either of two prevalent K. pneumoniae strains was more likely (P=.06) in residents in the isolation-precautions section. The estimated costs of contact-isolation precautions were 40% greater than those of routine glove use. CONCLUSION: There was a similar frequency of transmission of antimicrobial-resistant bacteria in the two study sections; there was evidence for resident-to-resident K. pneumoniae transmission in the isolation-precautions section. Routine glove use for healthcare workers, which decreases resident social isolation and healthcare facility costs, may be preferable in many long-term care facilities.