The purpose of this study was to determine the impact of Regulation 1 of CLIA '88 on personnel needs in clinical laboratories of acute care hospitals in Virginia, resulting from proficiency testing, complexity level of testing and personnel standards. Because the legislation was enacted and passed with the intent of improving the quality of laboratory testing in every setting, the problem of the study was to determine the effects Regulation 1 of CLIA ’88 had on personnel needs for the delivery of quality clinical laboratory services in acute care hospitals of Virginia. A survey was sent to 140 acute care hospital laboratories in Virginia. There were 107 respondents, with 75 respondents providing usable data for this study. The remainder did not provide full laboratory services. Demographic information was obtained regarding bed capacity, educational levels of current personnel serving in different capacities, test volume, and percent of tests performed by different complexity levels. Comparisons were made among small, medium, and large facilities. The majority of respondents were representative of a facility with a bed capacity of 200 or less. The level of test complexity performed was similar regardless of the facility size. The majority of facilities did not anticipate an increase in personnel needs as a result of CLIA personnel standards. All facilities had personnel at all capacities that met required educational levels at this time. The majority of facilities did not anticipate an increase in personnel as a result of increased proficiency testing; however, when a projected need was indicated, there was a greater need indicated for AS degree level personnel followed by BS level personnel with a decline indicated in non degreed personnel. Staffing pattern changes related to increased proficiency testing indicated differences in the projected needs of small, medium, and large facilities. Barriers for implementing CLIA ’88 personnel standards were identified from the literature review and the pilot study. Respondents were asked to identify the barriers that were most Significant; they are in order as ranked: cost, availability of qualified personnel, and CLIA not reflecting the depth of knowledge and judgment needed to make independent competent judgment. The barriers were also reviewed by hospital bed size. It was concluded that as the number of tests being sent out increased, the number of tests being performed in-house have increased at the moderate complexity level, a level which requires less qualified personnel. The intent of the law to improve the quality of laboratory testing has not occurred in every setting. If the intent of the law is implemented, a need exists to provide educational opportunities at the AS and BS level for experienced personnel. Respondents did not perceive criteria as established by CLIA ‘88 as being adequate to determine the qualifications of personnel, who are responsible for quality patient test results in all settings. / Ed. D.