Implementation of an expanded point-of-care testing (POCT) site inspection checklist in a large academic medical center: Implications for the management of a POCT program

• Published in: Clinica chimica acta 2012-12, Vol.414, p.27-33
• Main Authors: Gregory, Kimberly, Tse, Julie Y., Wu, Roseann, Lewandrowski, Kent
• Format: Article
• Language: English
• Subjects: Academic Medical Centers; Database Management Systems; Near patient testing; Point of care testing; Point-of-Care Systems; Regulatory compliance; Site inspections
• ISSN: 0009-8981; 1873-3492
• DOI: 10.1016/j.cca.2012.07.015

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. 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. 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. 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. ► This study reports an evaluation of an expanded point-of-care site inspection checklist. ► The expanded checklist was modeled after Joint Commission requirements including environment of care and safety. ► The most common deficiencies related to safety, procedures and competency assessment. ► Regular site inspections are required to maintain regulatory compliance.