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• We describe the structure and scope of a POCT program in a large hospital. • The POCT team consists of 2.9 staff for a cost of $0.80 per test. • POCT tests comprise 10.8% of all tests performed in our institution. • Multiple POCT vendors are used as no vendor can supply all of our POCT needs. Point-of-care testing (POCT) is an important component of hospital-based and ambulatory laboratory testing. Despite its importance, there is relatively little in the peer reviewed literature describing the details of successful POCT programs. Administrative records and test volumes from the Massachusetts General Hospital were compiled using POCT middleware (Telcor) and the hospital information system (Epic). Financial data was derived from vendor contracts and the hospital budget management system. Our POCT management team consists of 2.8 medical technologists and 0.1 medical director with an annual labor cost of $458,000 ($0.80/test). The team oversees quality and regulatory compliance for 143 testing sites. POCT constitutes 24 tests with an annual volume of over 573,000 tests (10.8% of all tests performed). Regular site inspections utilizing a compliance checklist with mandatory remedial action plans are employed. This approach has reduced inspection citations from 3.17 per testing site to 0.27 citations. The average cost of POCT tests is $1.89. POCT is widespread in our institution and comprises a significant percentage of the total test volume. A dedicated POCT team combined with regular site inspections using a comprehensive checklist facilitates regulatory compliance and quality testing. [ABSTRACT FROM AUTHOR]

Abstract: Background: Management of point-of-care testing (POCT) continues to present challenges. The use of site inspections by POCT coordinators has been a mainstay for maintaining regulatory compliance in POCT although this process is labor intensive. Improvements in device design and the use of POCT data management systems have improved the ability of hospitals to manage POCT programs. Given these developments, using regular site inspections to ensure regulatory compliance of POCT may be less relevant than in the past. Methods: We implemented an expanded POCT site inspection checklist modeled after the requirements of the Joint Commission. The checklist included categories not specifically related to POCT such as the environment of care and safety. Results: The average number of deficiencies per site in 2011 was 2.37 (range 0–10) out of a possible 42. Only 18% of site inspections produced no citations. In contrast in 2010 the average number of deficiencies per site was 3.17 (out of a possible 32) and only 8.7% of sites had no citations. The difference in the number of deficiencies per site was significant (t-test two tailed p=0.04). The most frequently cited deficiencies (24.2%) related to safety followed by maintenance of proper procedures and documentation of competency assessment. Conclusions: Despite improvements in many POCT devices and data management systems, regular site inspections are still required to identify regulatory deficiencies and improve testing quality. The use of an expanded site inspection checklist will identify many areas for improvement that are not specifically related to POCT alone. [Copyright &y& Elsevier]

Background We evaluated the effectiveness of an expanded point-of-care (POCT) site inspection checklist over an extended 8-y period. Methods A retrospective review of site inspection deficiency reports in a large academic medical center from 2010 to 2017 (year to date). Results There was a significant decrease in the number of cited deficiencies per site/inspection from 2010 (3.17) to 2017 (0.27) ( p < 0.001). The percentage of sites without deficiencies steadily increased from 2010 (8.7%) to 2017 (80.7%) ( p < 0.001). The most common citation was documentation of competency assessment followed by results documentation and annual procedure review. Conclusions Regular inspections of sites performing POCT are necessary to maintain regulatory compliance. Over time significant improvements in compliance are achievable. [ABSTRACT FROM AUTHOR]