Preventing medical errors in point-of-care testing: security, validation, safeguards, and connectivity..

OBJECTIVES o prevent medical errors, improve user performance, and enhance the quality, safety, and connectivity (bidirectional communication) of point-of-care testing. PARTICIPANTS Group A included 37 multidisciplinary experts in point-of-care testing programs in critical care and other hospital disciplines. Group B included 175 professional point-of-care managers, specialists, clinicians, and researchers. The total number of participants equaled 212. EVIDENCE This study followed a systems approach. Expert specifications for prevention of medical errors were incorporated into the designs of security, validation, performance, and emergency systems. Additional safeguards need to be implemented through instrument software options and point-of-care coordinators. Connectivity will be facilitated by standards that eliminate deficiencies in instrument communication and device compatibility. Assessment of control features on handheld, portable, and transportable point-of-care instruments shows that current error reduction features lag behind needs. CONCENSUS PROCESS: Step 1: United States national survey and collation of group A expert requirements for security, validation, and performance. Step 2: Design of parallel systems for these functions. Step 3: Written critique and improvement of the error-prevention systems during 4 successive presentations to group B participants over 9 months until system designs stabilized into final consensus form. CONCLUSIONS The consensus process produced 6 conclusions for preventing medical errors in point-of-care testing: (1) adopt operator certification and validation in point-of-care testing programs; (2) implement security, validation, performance, and emergency systems on existing and new devices; (3) require flexible, user-defined error-prevention system options on instruments as a prerequisite to federal licensing of new diagnostic tests and devices; (4) integrate connectivity standards for bidirectional information exchange; (5) preserve fast therapeutic turnaround time of point-of-care test results; and (6) monitor invalid use, operator competence, quality compliance, and other performance improvement indices to reduce errors, thereby focusing on patient outcomes.(Arch Pathol Lab Med. 2001;1307-1315)

[1]  Alastair Baker,et al.  Crossing the Quality Chasm: A New Health System for the 21st Century , 2001, BMJ : British Medical Journal.

[2]  S T Bennett,et al.  Quality improvement in the information age. , 1999, MLO: medical laboratory observer.

[3]  R. Sirota.  The Institute of Medicine's report on medical error. Implications for pathology. , 2000, Archives of pathology & laboratory medicine.

[4]  C P Price,et al.  Point of Care Testing , 1999, BMJ : British Medical Journal.

[5]  G J Kost,et al.  Point-of-care glucose testing: effects of critical care variables, influence of reference instruments, and a modular glucose meter design. , 2000, Archives of pathology & laboratory medicine.

[6]  G J Kost,et al.  Critical limits for urgent clinician notification at US medical centers. , 1990, JAMA.

[7]  R W Jenny,et al.  Causes of unsatisfactory performance in proficiency testing. , 2000, Clinical chemistry.

[8]  A. Wall,et al.  Book ReviewTo Err is Human: building a safer health system Kohn L T Corrigan J M Donaldson M S Washington DC USA: Institute of Medicine/National Academy Press ISBN 0 309 06837 1 $34.95 , 2000 .

[9]  S J Steindel,et al.  Evaluating stat testing options in an academic health center: therapeutic turnaround time and staff satisfaction. , 1998, Clinical chemistry.

[10]  S J Steindel,et al.  Continuous quality improvement for point-of-care testing using background monitoring of duplicate specimens. , 1999, Archives of pathology & laboratory medicine.

[11]  G. Kost,et al.  Critical limits for emergency clinician notification at United States children's hospitals. , 1991, Pediatrics.

[12]  D. Witte,et al.  Frequency of unacceptable results in point-of-care testing. , 1999, Archives of pathology & laboratory medicine.

[13]  G. Kost.  Using critical limits to improve patient outcome. , 1993, MLO: medical laboratory observer.

[14]  M L Astion,et al.  Panel discussion: how to monitor and minimize variation and mistakes. , 1997, Clinical chemistry.

[15]  G J Kost,et al.  The laboratory-clinical interface: point-of-care testing. , 1999, Chest.

[16]  G J Kost.  Optimizing point-of-care testing in clinical systems management. , 1998, Clinical laboratory management review : official publication of the Clinical Laboratory Management Association.

[17]  G J Kost,et al.  Effects of drugs on glucose measurements with handheld glucose meters and a portable glucose analyzer. , 2000, American journal of clinical pathology.

[18]  G. Kost,et al.  Point-of-Care Testing: Millennium Technology for Critical Care , 2000 .

[19]  L L Leape,et al.  Institute of Medicine medical error figures are not exaggerated. , 2000, JAMA.

[20]  M Plebani,et al.  Mistakes in a stat laboratory: types and frequency. , 1997, Clinical chemistry.

[21]  D. Witte,et al.  Errors, mistakes, blunders, outliers, or unacceptable results: how many? , 1997, Clinical chemistry.

[22]  G J Kost,et al.  Connectivity. The millennium challenge for point-of-care testing. , 2000, Archives of pathology & laboratory medicine.

[23]  L. Kohn,et al.  To Err Is Human : Building a Safer Health System , 2007 .

[24]  Kern Da,et al.  Quality improvement in the information age. , 1999 .

[25]  G. Kost,et al.  Guidelines for point-of-care testing. Improving patient outcomes. , 1995, American journal of clinical pathology.

[26]  G. Kost.  The hybrid laboratory: shifting the focus to the point of care. , 1992, MLO: medical laboratory observer.

[27]  L. Leape.  Error in medicine. , 1994, JAMA.

[28]  C J McDonald,et al.  Deaths due to medical errors are exaggerated in Institute of Medicine report. , 2000, JAMA.

[29]  Martin J. Tobin,et al.  Principles and Practice of Intensive Care Monitoring. , 1997 .

[30]  H Ballam.  HIPAA, security, and electronic signature: a closer look. , 1999, Journal of AHIMA.

[31]  M F Burritt,et al.  Point-of-care testing. , 1995, Mayo Clinic proceedings.