Strategies for establishing policy, environmental, and systems-level interventions for managing high blood pressure and high cholesterol in health care settings: a qualitative case study.

INTRODUCTION: Policy, environmental, and systems-level interventions are part of a comprehensive approach to managing high blood pressure and high cholesterol, which are key risk factors for heart disease and stroke. In this qualitative case study, we identified clinical practices in health care organizations that used policy, environmental, or systems-level interventions to improve patient outcomes for these conditions. Our 4 objectives were to describe 1) policy, environmental, and systems-level interventions; 2) enabling factors and barriers that affected implementation; 3) methods for evaluating the success of the intervention; and 4) lessons learned from the health care practices that implemented these interventions. METHODS: Through literature review and expert guidance, we identified 34 health care practices that used policy, environmental, and systems-level interventions to manage high blood pressure and high cholesterol. In 2003, we conducted case study interviews with key informants for 9 health care practices that 1) demonstrated improved patient outcomes for blood pressure or cholesterol; 2) implemented the interventions for at least 1 year; and 3) remained committed to sustaining or institutionalizing interventions. We taped and transcribed the interviews and used Centers for Disease Control and Prevention EZ-Text software (www.cdc.gov/hiv/software/ez-text.htm) to code, categorize, and analyze the responses. RESULTS: The health care practices we studied implemented specialized lipid clinics, disease management programs, physician reminder systems, and participation in the Health Resources and Services Administration's Bureau of Primary Care Health Disparities Collaboratives. All practices used comprehensive systems for patient care that were well-defined, measurable, and linked to desirable patient outcomes. Most relied on data systems to identify patients targeted for the interventions and practice areas that needed improvement, and to track the progress of patients and practitioners in meeting goals. Factors contributing to success included support for patient self-management, interventions integrated into the practice's daily work flow to make implementation easier for staff, leadership and staff commitment, and community involvement. CONCLUSION: Comprehensive policy, environmental, and systems-level interventions for patient care can be effective in controlling chronic conditions such as high blood pressure and high cholesterol.

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.

Practice patterns of testing waived under the clinical laboratory improvement amendments.

OBJECTIVES: To determine operational practices in laboratories operating under a Certificate of Wavier (waived laboratories), or equivalent, under the Clinical Laboratory Improvements Amendments (CLIA) of 1988 when performing tests designated as having an insignificant risk of an erroneous result (ie, waived tests). METHODS: Waived laboratories that were part of the Centers for Disease Control and Prevention Laboratory Sentinel Monitoring Network project in the states of Arkansas, New York, and Washington were surveyed about their quality control (QC) and quality assurances (QA) practices when performing waived testing. Arkansas and Washington sent out similar questionnaires, whereas on-site surveys were conducted in New York. The survey in Arkansas and Washington also included nonwaived laboratories. The New York visits were designed to pilot test a regulatory inspection program for limited testing sites, which, in New York, are roughly equivalent to laboratories operating under a CLIA Certificate of Wavier and/or Provider-Performed Microscopy but are generally not located in physicians' offices. Laboratories visited in New York were selected from a list of limited testing sites and were representative of that population. RESULTS: Arkansas received responses from 211 facilities (37% response rate), of which 38% had Certificates of Waiver. Washington received responses from 190 waived laboratories (71% response rate) and from 116 nonwaived laboratories (32% response rate). In New York, 607 of the 2751 limited testing laboratories were visited. Reporting laboratories in all 3 states most frequently performed testing for glucose, urinalysis, urine human chorionic gonadotropin, occult blood, and group A Streptococcus antigen, although other waived tests were performed less frequently. Washington found that 57% of waived laboratories followed manufacturers' QC requirements. Arkansas found that 58% of laboratories doing waived tests that required liquid controls performed these controls, and 59% performing waived testing requiring electronic controls used these controls. In New York, 68% of the laboratories complied with the manufacturer's QC requirements for a variety of tests. Being accredited by an external organization or affiliated with a more complex laboratory improved compliance. Nonwaived laboratories in Washington and Arkansas complied with manufacturer's instructions at a higher rate than did waived laboratories. Similar deficiencies in following CLIA requirements were found in other areas of laboratory operation. CONCLUSIONS: Just more than half of waived laboratories in 3 diverse states follow manufacturer's instructions for recommended QC and QA. These instructions help ensure that the test will produce results that have an insignificant chance of an error. Although we did not study the impact of this and other findings on patient care, the results show that imposing good laboratory practices by regulation alone was insufficient to ensure quality laboratory results in any location evaluated. A system that can continually provide accessible education on laboratory practices, coupled with new thoughts on the regulatory environment, is in order.