Yearb Med Inform 2008; 17(01): 105-113
DOI: 10.1055/s-0038-1638590
Original Article
Georg Thieme Verlag KG Stuttgart

Traceability in Healthcare: Crossing Boundaries

C. Lovis
1   University hospitals of Geneva, Service of Medical informatics, Geneva, Switzerland Chair of the European Federation of Medical Informatics Working Group on Traceability
› Author Affiliations
Further Information

Correspondence to

Christian Lovis, MD MPH
University Hospitals of Geneva
Service of Medical Informatics
Unit of Clinical Informatics
24, Rue Micheli-du-Crest
1211 Geneva 4
Switzerland
Phone: +41 22 3726169   

Publication History

Publication Date:
07 March 2018 (online)

 

Summary

Objectives This paper is a survey on the problem of traceability in healthcare. Traceability covers many different aspects and its understanding varies among different players. In supply chains and retails, traceability usually covers aspects pertaining to logistics. The challenge is to keep trace of objects manufactured, to track their locations in a production and distribution processes. In food industry, traceability has received a lot of attention because of public health problems related to infectious diseases. For instance, in Europe, the challenge of traceability has been to build the tracking of meat, from the living animal to the shell. In the health sector, traceability has mostly been involved in patient safety around human products such as blood derivates contaminants or implanted devices and prosthesis such as mammary implants. There are growing interests involving traceability in health related to drug safety, including the problem of counterfeited drugs, and to privacy. Traceability is also increasingly seen as a mean to improve efficiency of the logistics of care and a way to better understand costs and usage of resources.

Methods This survey is reviewing the literature and proposes a discussion based on the real use and needs of traceability in a large teaching hospital.

Results and Conclusion Traceability in healthcare is at the crossroads of numerous needs. It is therefore of particular complexity and raises many new challenges. Identification management and entity tracking, from serialization of consumers’ good production in the supply chains, to the identification of actors, patients, care providers, locations and processes is a huge effort, tackling economical, political, ethical and technical challenges. New requirements are needed, not usually met in the supply chain, such as serialization and persistence in time. New problems arise, such as privacy and legal frameworks. There are growing needs to increase traceability for drug products, related to drug safety, counterfeited drugs, and to privacy. Technical problems around reliability, robustness and efficiency of carriers are still to be resolved. There is a lot at stakes. Traceability is a major aspect of the future in healthcare and requires the attention of the community of medical informatics.


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  • References

  • 1 Lupien JR. Food quality and safety: traceability and labeling. Crit Rev Food Sci Nutr 2005; 45 (02) 119-23.
  • 2 Miller JL, Thompson PA, Orabella MM. Forecasting in foodservice: model development, testing, and evaluation. J Am Diet Assoc 1991; 91 (05) 569-74.
  • 3 Rajic A, Waddell LA, Sargeant JM, Read S, Farber J, Firth MJ. et al. An overview of microbial food safety programs in beef, pork, and poultry from farm to processing in Canada. J Food Prot 2007; May; 70 (05) 1286-94.
  • 4 Berg L. Trust in food in the age of mad cow disease: a comparative study of consumers’ evaluation of food safety in Belgium, Britain and Norway. Appetite 2004; Feb; 42 (01) 21-32.
  • 5 Pettitt RG. Traceability in the food animal industry and supermarket chains. Rev Sci Tech 2001; Aug; 20 (02) 584-97.
  • 6 Cheek P. Factors impacting the acceptance of traceability in the food supply chain in the United States of America. Rev Sci Tech 2006; Apr; 25 (01) 313-9.
  • 7 Armbruster D, Miller RR. The Joint Committee for Traceability in Laboratory Medicine (JCTLM): A Global Approach to Promote the Standardisation of Clinical Laboratory Test Results. Clin Biochem Rev 2007; Aug; 28 (03) 105-14.
  • 8 Faber JC. Worldwide overview of existing haemovigilance systems. Transfus Apher Sci 2004; Oct; 31 (02) 99-110.
  • 9 Flanagan P. Product traceability and lookback: assuring the integrity of the transfusion process. Dev Biol (Basel) 2007; 127: 225-33.
  • 10 Gac A, Durand MP. Cold chain the concept of traceability practical applications. Bull Acad Natl Med 2001; 185 (02) 301-10.
  • 11 James JS. FDA, companies test RFID tracking to prevent drug counterfeiting. AIDS Treat News 2005; Dec (417) 5-8.
  • 12 Spahni S, Lovis C, Ackermann M, Mach N, Bonnabry P, Geissbuhler A. Securing chemotherapies: fabrication, prescription, administration and complete traceability. Medinfo 2007; 12 (Pt 2): 953-7.
  • 13 Scott MG, Morin S, Hock KG, Seyoum M, Ladenson JH. Establishing a simple and sustainable quality assurance program and clinical chemistry services in Eritrea. Clin Chem 2007; Nov; 53 (11) 1945-53.
  • 14 Panteghini M. Traceability, reference systems and result comparability. Clin Biochem Rev 2007; Aug; 28 (03) 97-104.
  • 15 Staccini P, Joubert M, Quaranta JF, Fieschi D, Fieschi M. Integration of health care process analysis in the design of a clinical information system: applying to the blood transfusion process. Proc AMIA Symp 2000; 824-8.
  • 16 GS1. General specifications 2008. Version 8.1. 2002008 January, 2005.
  • 17 bITAC. Report to the President, Revolutionizing Health Care through Information technology. President’s Information Technology advisory Committee. June 2004
  • 18 Auttonberry D. “To err is human”-or is it process?. J Miss State Med Assoc 2000; 41 (02) 499.
  • 19 IOM, editor. To Err is Human. Building a safer Health System. National Academy Press; 1999
  • 20 Kohn LT. To err is human building a safer health system. Washington, D.C: National Academy Press; 2000
  • 21 Leape LL, Brennan TA, Laird N, Lawthers AG, Localio AR, Barnes BA. et al. The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II.. N Engl J Med 1991; Feb 7; 324 (06) 377-84.
  • 22 Schulz S, Hanser S, Hahn U, Rogers J. The semantics of procedures and diseases in SNOMED CT. Methods Inf Med 2006; 45 (04) 354-8.
  • 23 Schulz S, Suntisrivaraporn B, Baader F. SNOMED CT’s problem list: ontologists’ and logicians’ therapy suggestions. Medinfo 2007; 12 (Pt 1): 802-6.
  • 24 Smith B, Ceusters W. HL7 RIM: an incoherent standard. Stud Health Technol Inform 2006; 124: 133-8.
  • 25 Hill EC. Clear cell carcinoma of the cervix and vagina in young women. A report of six cases with association of maternal stilbestrol therapy and adenosis of the vagina. Am J Obstet Gynecol 1973; Jun 15; 116 (04) 470-84.
  • 26 Hillemanns HG, Bauknecht T, Simmer H. The stilbestrol-adenosis-carcinoma syndrome. Obstet Gynecol Surv 1979; Nov; 34 (11) 814-7.
  • 27 Ulfelder H. The stilbestrol-adenosis-carcinoma-syndrome. A review. Geburtshilfe Frauenheilkd 1975; May; 35 (05) 329-33.
  • 28 Kabachinski J. An introduction to RFID. Biomed Instrum Technol 2005; Mar-Apr; 39 (02) 131-4.
  • 29 Asamoah AK. Not as easy as it may appear: using radio frequency identification technology to fulfill the Prescription Drug Marketing Act’s elusive pedigree requirement. Food Drug Law J 2006; 61 (02) 385-418.
  • 30 Boulard G. RFID: promise or peril? It may be easier than ever to track information, but it is causing concerns over privacy and civil liberties. State Legis 2005; Dec; 31 (10) 22-4.
  • 31 Dinh AK. RFID systems in healthcare. Emerging uses and potential issues. J AHIMA 2008; Jan; 79 (01) 62-3.
  • 32 Fanberg H. The RFID revolution. Mark Health Serv 2004; Fall; 24 (03) 43-4.
  • 33 Prescription Drug Marketing Act Pedigree Requirements; effective date and compliance policy guide; request for comment. Final rule; announcement of effective date; notice of availability; request for comment. Fed Regist 2006; Jun 14; 71 (114) 34249-51.
  • 34 Young D. FDA embraces RFID to protect drug supply. Am J Health Syst Pharm 2004; Dec 15; 61 (24) 2612-5.

Correspondence to

Christian Lovis, MD MPH
University Hospitals of Geneva
Service of Medical Informatics
Unit of Clinical Informatics
24, Rue Micheli-du-Crest
1211 Geneva 4
Switzerland
Phone: +41 22 3726169   

  • References

  • 1 Lupien JR. Food quality and safety: traceability and labeling. Crit Rev Food Sci Nutr 2005; 45 (02) 119-23.
  • 2 Miller JL, Thompson PA, Orabella MM. Forecasting in foodservice: model development, testing, and evaluation. J Am Diet Assoc 1991; 91 (05) 569-74.
  • 3 Rajic A, Waddell LA, Sargeant JM, Read S, Farber J, Firth MJ. et al. An overview of microbial food safety programs in beef, pork, and poultry from farm to processing in Canada. J Food Prot 2007; May; 70 (05) 1286-94.
  • 4 Berg L. Trust in food in the age of mad cow disease: a comparative study of consumers’ evaluation of food safety in Belgium, Britain and Norway. Appetite 2004; Feb; 42 (01) 21-32.
  • 5 Pettitt RG. Traceability in the food animal industry and supermarket chains. Rev Sci Tech 2001; Aug; 20 (02) 584-97.
  • 6 Cheek P. Factors impacting the acceptance of traceability in the food supply chain in the United States of America. Rev Sci Tech 2006; Apr; 25 (01) 313-9.
  • 7 Armbruster D, Miller RR. The Joint Committee for Traceability in Laboratory Medicine (JCTLM): A Global Approach to Promote the Standardisation of Clinical Laboratory Test Results. Clin Biochem Rev 2007; Aug; 28 (03) 105-14.
  • 8 Faber JC. Worldwide overview of existing haemovigilance systems. Transfus Apher Sci 2004; Oct; 31 (02) 99-110.
  • 9 Flanagan P. Product traceability and lookback: assuring the integrity of the transfusion process. Dev Biol (Basel) 2007; 127: 225-33.
  • 10 Gac A, Durand MP. Cold chain the concept of traceability practical applications. Bull Acad Natl Med 2001; 185 (02) 301-10.
  • 11 James JS. FDA, companies test RFID tracking to prevent drug counterfeiting. AIDS Treat News 2005; Dec (417) 5-8.
  • 12 Spahni S, Lovis C, Ackermann M, Mach N, Bonnabry P, Geissbuhler A. Securing chemotherapies: fabrication, prescription, administration and complete traceability. Medinfo 2007; 12 (Pt 2): 953-7.
  • 13 Scott MG, Morin S, Hock KG, Seyoum M, Ladenson JH. Establishing a simple and sustainable quality assurance program and clinical chemistry services in Eritrea. Clin Chem 2007; Nov; 53 (11) 1945-53.
  • 14 Panteghini M. Traceability, reference systems and result comparability. Clin Biochem Rev 2007; Aug; 28 (03) 97-104.
  • 15 Staccini P, Joubert M, Quaranta JF, Fieschi D, Fieschi M. Integration of health care process analysis in the design of a clinical information system: applying to the blood transfusion process. Proc AMIA Symp 2000; 824-8.
  • 16 GS1. General specifications 2008. Version 8.1. 2002008 January, 2005.
  • 17 bITAC. Report to the President, Revolutionizing Health Care through Information technology. President’s Information Technology advisory Committee. June 2004
  • 18 Auttonberry D. “To err is human”-or is it process?. J Miss State Med Assoc 2000; 41 (02) 499.
  • 19 IOM, editor. To Err is Human. Building a safer Health System. National Academy Press; 1999
  • 20 Kohn LT. To err is human building a safer health system. Washington, D.C: National Academy Press; 2000
  • 21 Leape LL, Brennan TA, Laird N, Lawthers AG, Localio AR, Barnes BA. et al. The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II.. N Engl J Med 1991; Feb 7; 324 (06) 377-84.
  • 22 Schulz S, Hanser S, Hahn U, Rogers J. The semantics of procedures and diseases in SNOMED CT. Methods Inf Med 2006; 45 (04) 354-8.
  • 23 Schulz S, Suntisrivaraporn B, Baader F. SNOMED CT’s problem list: ontologists’ and logicians’ therapy suggestions. Medinfo 2007; 12 (Pt 1): 802-6.
  • 24 Smith B, Ceusters W. HL7 RIM: an incoherent standard. Stud Health Technol Inform 2006; 124: 133-8.
  • 25 Hill EC. Clear cell carcinoma of the cervix and vagina in young women. A report of six cases with association of maternal stilbestrol therapy and adenosis of the vagina. Am J Obstet Gynecol 1973; Jun 15; 116 (04) 470-84.
  • 26 Hillemanns HG, Bauknecht T, Simmer H. The stilbestrol-adenosis-carcinoma syndrome. Obstet Gynecol Surv 1979; Nov; 34 (11) 814-7.
  • 27 Ulfelder H. The stilbestrol-adenosis-carcinoma-syndrome. A review. Geburtshilfe Frauenheilkd 1975; May; 35 (05) 329-33.
  • 28 Kabachinski J. An introduction to RFID. Biomed Instrum Technol 2005; Mar-Apr; 39 (02) 131-4.
  • 29 Asamoah AK. Not as easy as it may appear: using radio frequency identification technology to fulfill the Prescription Drug Marketing Act’s elusive pedigree requirement. Food Drug Law J 2006; 61 (02) 385-418.
  • 30 Boulard G. RFID: promise or peril? It may be easier than ever to track information, but it is causing concerns over privacy and civil liberties. State Legis 2005; Dec; 31 (10) 22-4.
  • 31 Dinh AK. RFID systems in healthcare. Emerging uses and potential issues. J AHIMA 2008; Jan; 79 (01) 62-3.
  • 32 Fanberg H. The RFID revolution. Mark Health Serv 2004; Fall; 24 (03) 43-4.
  • 33 Prescription Drug Marketing Act Pedigree Requirements; effective date and compliance policy guide; request for comment. Final rule; announcement of effective date; notice of availability; request for comment. Fed Regist 2006; Jun 14; 71 (114) 34249-51.
  • 34 Young D. FDA embraces RFID to protect drug supply. Am J Health Syst Pharm 2004; Dec 15; 61 (24) 2612-5.