p isbt 128 p description c d h reporting a · product description code database for haemovigilance...

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POTENTIAL USE OF THE ISBT 128 PRODUCT DESCRIPTION CODE DATABASE FOR HAEMOVIGILANCE REPORTING AND ANALYSIS Mónica Freire 1 , Pat Distler 1 Background The ISBT 128 labelling standard was created in 1994 as an international strategy for improving transfusion safety. ISBT 128 ensures unique identification and traceability of blood products using a rigorous coding system based on internationally agreed terminology. The World Health Organization has recognized the ISBT 128 Standard as the sole global standard for identification and coding of medical products of human origin. Reporting and analysing denominator data for haemovigilance can be labour-intensive. Because of this, the potential use of ISBT 128 product codes and their supporting database to automate this process was explored. Aims Evaluate the potential use of ISBT 128 product codes and supporting Product Description Code Database for haemovigilance reporting and analysis of denominator data. Methods Internationally standardized terminology is used to uniquely describe products that are then given ISBT 128 product description codes. For example, the product “Apheresis PLATELETS/ACD-A/XX/20- 24C|Irradiated|Residual Leukocytes <5E6” has been given the code “E3046.” Each characteristic within a product description is given a code and these codes are combined to create a unique formula. CHARACTERISTIC CODE Platelets C0006 Apheresis M0007 ACD-A/XX/20-24C V0001073 Irradiated V0013002 Residual Leukocytes: <5E6 V0014004 Formula for this product : C0006-M0007-V0001073-V0013002-V0014004 Results The information in the ISBT 128 Product Description Code Database can support haemovigilance efforts. Transfusion facilities may report denominator data using ISBT 128 product codes and haemovigilance organizations can link the product codes to the descriptions and formulae in the ISBT 128 database. Data can then be sorted, filtered, and analysed. Summary/Conclusions The use of ISBT 128 product codes and the supporting database can support national and international haemovigilance efforts by providing product descriptions in computer-friendly formulae for analysis of denominator data. Each year, over 42 million blood products are labelled with ISBT 128 product codes and this could provide a rich source of denominator data. The reporting and analysis of this data can potentially be standardized and automated. In the US, the Centers for Disease Control are incorporating ISBT 128 formulae into their haemovigilance reporting and analysis system. 1 ICCBBA, Redlands, California, USA Methods - continued Such formulae support sorting, filtering, and enumeration of data by characteristics of interest. For example, the number of irradiated products in denominator data can be determined by filtering for “irradiated” (“V0013002” within the formula). Furthermore, the search can be narrowed to identify all apheresis platelets that were irradiated and leukocyte reduced. The ISBT 128 Product Description Code Database contains over 8,000 blood products that reflect different combinations of >250 characteristics. The high level of granularity within the ISBT 128 product description permits detailed analysis. The ISBT 128 database is regularly updated and expanded as new technologies emerge and standards evolve. E3041 C0006-M0007-V0001073-V0012002-V0018005 E3042 C0006-M0007-V0001073-V0012002-V0018006 E3043 C0006-M0007-V0001073-V0012002-V0018007 E3044 C0006-M0007-V0001073-V0012002-V0018008 E3045 C0006-M0007-V0001073-V0013002 E3046 C0006-M0007-V0001073-V0013002-V0014004 E3047 C0006-M0007-V0001073-V0013002-V0014004-V0015005 E3048 C0006-M0007-V0001073-V0013002-V0014004-V0015005-V0018002 E3049 C0006-M0007-V0001073-V0013002-V0014004-V0015005-V0018003 E3050 C0006-M0007-V0001073-V0013002-V0014004-V0015005-V0018004 E3051 C0006-M0007-V0001073-V0013002-V0014004-V0015005-V0018005 E3052 C0006-M0007-V0001073-V0013002-V0014004-V0015005-V0018006 E3053 C0006-M0007-V0001073-V0013002-V0014004-V0015005-V0018007 E3054 C0006-M0007-V0001073-V0013002-V0014004-V0015005-V0018008 E3055 C0006-M0007-V0001073-V0013002-V0014004-V0018002 E3056 C0006-M0007-V0001073-V0013002-V0014004-V0018003 E3057 C0006-M0007-V0001073-V0013002-V0014004-V0018004 E3058 C0006-M0007-V0001073-V0013002-V0014004-V0018005 E3059 C0006-M0007-V0001073-V0013002-V0014004-V0018006 Product Description Code (PDC) ISBT 128 PRODUCT DESCRIPTION CODE DATABASE C0006 Platelets M0007 Apheresis V0001073 ACD-A/XX/20-24C V0013002 Irradiated V0014004 Residual Leukocytes:<5E6 ISBT 128 FORMULA C0006-M0007-V0001073-V0013002-V0014004 APHERESIS PLATELETS IRRADIATED LEUKOCYTES REDUCED COMPUTERIZED DATA SORTING BY PRODUCT CHARACTERISTIC E3046 E3041 C0006-M0007-V0001073-V0012002-V0018005 E3042 C0006-M0007-V0001073-V0012002-V0018006 E3043 C0006-M0007-V0001073-V0012002-V0018007 E3044 C0006-M0007-V0001073-V0012002-V0018008 E3045 C0006-M0007-V0001073-V0013002 E3046 C0006-M0007-V0001073-V0013002-V0014004 E3047 C0006-M0007-V0001073-V0013002-V0014004-V0015005 E3048 C0006-M0007-V0001073-V0013002-V0014004-V0015005-V0018002 E3049 C0006-M0007-V0001073-V0013002-V0014004-V0015005-V0018003 E3050 C0006-M0007-V0001073-V0013002-V0014004-V0015005-V0018004 E3051 C0006-M0007-V0001073-V0013002-V0014004-V0015005-V0018005 E3052 C0006-M0007-V0001073-V0013002-V0014004-V0015005-V0018006 E3053 C0006-M0007-V0001073-V0013002-V0014004-V0015005-V0018007 E3054 C0006-M0007-V0001073-V0013002-V0014004-V0015005-V0018008 E3055 C0006-M0007-V0001073-V0013002-V0014004-V0018002 E3056 C0006-M0007-V0001073-V0013002-V0014004-V0018003 E3057 C0006-M0007-V0001073-V0013002-V0014004-V0018004 E3058 C0006-M0007-V0001073-V0013002-V0014004-V0018005 E3059 C0006-M0007-V0001073-V0013002-V0014004-V0018006 ISBT 128 PRODUCT DESCRIPTION CODE DATABASE ISBT 128 FORMULAS C0006-M0007-V0001073-V0013002 C0006-M0007-V0001073-V0013002-V0014004 Apheresis Platelets Irradiated M0007 C0006 V0013002 M0007 C0006 V0013002 M0007 C0006 V0013002 M0007 C0006 V0013002 M0007 C0006 V0013002 M0007 C0006 V0013002 M0007 C0006 V0013002 Apheresis Platelets Irradiated Apheresis Platelets Irradiated Leukocytes Reduced M0007 C0006 V0013002 V0014004 M0007 C0006 V0013002 V0014004 M0007 C0006 V0013002 V0014004 M0007 C0006 V0013002 V0014004 M0007 C0006 V0013002 V0014004 Apheresis Platelets Irradiated Leukocytes Reduced PDCs FILTERING AND ANALYSIS OF DENOMINATOR DATA REPORTING OF DENOMINATOR DATA 2,200,000 Apheresis Platelets reported DATA SORTING 45% 40% More than Identification ICCBBA IS AN INTERNATIONAL NON-GOVERNMENTAL ORGANIZATION (NGO) IN OFFICIAL RELATIONS WITH THE WORLD HEALTH ORGANIZATION (WHO) THAT MANAGES, DEVELOPS, AND LICENSES ISBT 128; THE INTERNATIONAL INFORMATION STANDARD FOR THE TERMINOLOGY, CODING AND LABELING OF MEDICAL PRODUCTS OF HUMAN ORIGIN. 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Page 1: P isBt 128 P descriPtion c d h rePorting a · Product Description Code Database for haemovigilance reporting and analysis of denominator data. Methods Internationally standardized

Potential use of the isBt 128 Product descriPtion code dataBase for haemovigilance rePorting and analysis

Mónica Freire1, Pat Distler1

BackgroundThe ISBT 128 labelling standard was created in 1994 as an international strategy for improving transfusion safety. ISBT 128 ensures unique identification and traceability of blood products using a rigorous coding system based on internationally agreed terminology. The World Health Organization has recognized the ISBT 128 Standard as the sole global standard for identification and coding of medical products of human origin.

Reporting and analysing denominator data for haemovigilance can be labour-intensive. Because of this, the potential use of ISBT 128 product codes and their supporting database to automate this process was explored.

AimsEvaluate the potential use of ISBT 128 product codes and supporting Product Description Code Database for haemovigilance reporting and analysis of denominator data.

MethodsInternationally standardized terminology is used to uniquely describe products that are then given ISBT 128 product description codes. For example, the product “Apheresis PLATELETS/ACD-A/XX/20-24C|Irradiated|Residual Leukocytes <5E6” has been given the code “E3046.” Each characteristic within a product description is given a code and these codes are combined to create a unique formula.

CHARACTERISTIC CODEPlatelets C0006

Apheresis M0007ACD-A/XX/20-24C V0001073

Irradiated V0013002Residual Leukocytes: <5E6 V0014004

Formula for this product : C0006-M0007-V0001073-V0013002-V0014004

ResultsThe information in the ISBT 128 Product Description Code Database can support haemovigilance efforts. Transfusion facilities may report denominator data using ISBT 128 product codes and haemovigilance organizations can link the product codes to the descriptions and formulae in the ISBT 128 database. Data can then be sorted, filtered, and analysed.

Summary/ConclusionsThe use of ISBT 128 product codes and the supporting database can support national and international haemovigilance efforts by providing product descriptions in computer-friendly formulae for analysis of denominator data.

Each year, over 42 million blood products are labelled with ISBT 128 product codes and this could provide a rich source of denominator data. The reporting and analysis of this data can potentially be standardized and automated. In the US, the Centers for Disease Control are incorporating ISBT 128 formulae into their haemovigilance reporting and analysis system.

1ICCBBA, Redlands, California, USA

Methods - continuedSuch formulae support sorting, filtering, and enumeration of data by characteristics of interest. For example, the number of irradiated products in denominator data can be determined by filtering for “irradiated” (“V0013002” within the formula). Furthermore, the search can be narrowed to identify all apheresis platelets that were irradiated and leukocyte reduced.

The ISBT 128 Product Description Code Database contains over 8,000 blood products that reflect different combinations of >250 characteristics. The high level of granularity within the ISBT 128 product description permits detailed analysis. The ISBT 128 database is regularly updated and expanded as new technologies emerge and standards evolve.

While the ISBT 128 Product Description Code Database was originally developed for blood products, it has been expanded to include other products—such as tissues, cells, organs, and milk—allowing it to be used in surveillance and vigilance for other products.

E3039 C0006-M0007-V0001073-V0012002-V0018003E3040 C0006-M0007-V0001073-V0012002-V0018004E3041 C0006-M0007-V0001073-V0012002-V0018005E3042 C0006-M0007-V0001073-V0012002-V0018006E3043 C0006-M0007-V0001073-V0012002-V0018007E3044 C0006-M0007-V0001073-V0012002-V0018008E3045 C0006-M0007-V0001073-V0013002E3046 C0006-M0007-V0001073-V0013002-V0014004E3047 C0006-M0007-V0001073-V0013002-V0014004-V0015005E3048 C0006-M0007-V0001073-V0013002-V0014004-V0015005-V0018002E3049 C0006-M0007-V0001073-V0013002-V0014004-V0015005-V0018003E3050 C0006-M0007-V0001073-V0013002-V0014004-V0015005-V0018004E3051 C0006-M0007-V0001073-V0013002-V0014004-V0015005-V0018005E3052 C0006-M0007-V0001073-V0013002-V0014004-V0015005-V0018006E3053 C0006-M0007-V0001073-V0013002-V0014004-V0015005-V0018007E3054 C0006-M0007-V0001073-V0013002-V0014004-V0015005-V0018008E3055 C0006-M0007-V0001073-V0013002-V0014004-V0018002E3056 C0006-M0007-V0001073-V0013002-V0014004-V0018003E3057 C0006-M0007-V0001073-V0013002-V0014004-V0018004E3058 C0006-M0007-V0001073-V0013002-V0014004-V0018005E3059 C0006-M0007-V0001073-V0013002-V0014004-V0018006E3060 C0006-M0007-V0001073-V0013002-V0014004-V0018007E3061 C0006-M0007-V0001073-V0013002-V0014004-V0018008

Product Description Code (PDC)

ISBT 128 PRODUCT DESCRIPTIONCODE DATABASE

C0006Platelets

M0007Apheresis

V0001073ACD-A/XX/20-24C

V0013002Irradiated

V0014004Residual Leukocytes:<5E6

ISBT 128 FORMULAC0006-M0007-V0001073-V0013002-V0014004

APHERESISPLATELETSIRRADIATEDLEUKOCYTESREDUCED

COMPUTERIZEDDATA SORTING

BYPRODUCT

CHARACTERISTIC

E3046

E3039 C0006-M0007-V0001073-V0012002-V0018003E3040 C0006-M0007-V0001073-V0012002-V0018004E3041 C0006-M0007-V0001073-V0012002-V0018005E3042 C0006-M0007-V0001073-V0012002-V0018006E3043 C0006-M0007-V0001073-V0012002-V0018007E3044 C0006-M0007-V0001073-V0012002-V0018008E3045 C0006-M0007-V0001073-V0013002E3046 C0006-M0007-V0001073-V0013002-V0014004E3047 C0006-M0007-V0001073-V0013002-V0014004-V0015005E3048 C0006-M0007-V0001073-V0013002-V0014004-V0015005-V0018002E3049 C0006-M0007-V0001073-V0013002-V0014004-V0015005-V0018003E3050 C0006-M0007-V0001073-V0013002-V0014004-V0015005-V0018004E3051 C0006-M0007-V0001073-V0013002-V0014004-V0015005-V0018005E3052 C0006-M0007-V0001073-V0013002-V0014004-V0015005-V0018006E3053 C0006-M0007-V0001073-V0013002-V0014004-V0015005-V0018007E3054 C0006-M0007-V0001073-V0013002-V0014004-V0015005-V0018008E3055 C0006-M0007-V0001073-V0013002-V0014004-V0018002E3056 C0006-M0007-V0001073-V0013002-V0014004-V0018003E3057 C0006-M0007-V0001073-V0013002-V0014004-V0018004E3058 C0006-M0007-V0001073-V0013002-V0014004-V0018005E3059 C0006-M0007-V0001073-V0013002-V0014004-V0018006E3060 C0006-M0007-V0001073-V0013002-V0014004-V0018007E3061 C0006-M0007-V0001073-V0013002-V0014004-V0018008

ISBT 128 PRODUCT DESCRIPTIONCODE DATABASE

ISBT 128 FORMULASC0006-M0007-V0001073-V0013002C0006-M0007-V0001073-V0013002-V0014004

Apheresis Platelets IrradiatedM0007 C0006 V0013002M0007 C0006 V0013002M0007 C0006 V0013002M0007 C0006 V0013002M0007 C0006 V0013002M0007 C0006 V0013002M0007 C0006 V0013002

ApheresisPlateletsIrradiated

Apheresis Platelets Irradiated Leukocytes Reduced

M0007 C0006 V0013002 V0014004M0007 C0006 V0013002 V0014004M0007 C0006 V0013002 V0014004M0007 C0006 V0013002 V0014004M0007 C0006 V0013002 V0014004

ApheresisPlateletsIrradiatedLeukocytes Reduced

PDCs

FILTERING AND ANALYSIS

OF DENOMINATOR

DATA

REPORTING OFDENOMINATOR DATA

2,200,000Apheresis Platelets

reported

DATA SORTING

45%

40%

More than Identification

ICCBBA Is An InternAtIonAl non-governmentAl orgAnIzAtIon (ngo) In offICIAl relAtIons wIth the world heAlth orgAnIzAtIon (who) thAt mAnAges, develops, And lICenses IsBt 128; the

InternAtIonAl InformAtIon stAndArd for the termInology, CodIng And lABelIng of medICAl produCts of humAn orIgIn.

www.ICCBBA.org

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