Output Based Specification for the Blood Spot Card Label

NHS Numbers for Newborn

Screening

Output Based Specification for the Blood Spot Card Label

Version No: 3.4

Issue Date: 17

th

November 2014

NHS Numbers for Newborn Screening

OBS - Blood spot label

NHS Newborn Blood Spot Screening Programme

UKNSLN / NHS Connecting for Health

Purpose of this document

The purpose of this document is to provide the output based specification for the production of ‘standard sticky labels’ so as to enable all maternity units to print such labels with the NHS number which will be given to the mother, usually before discharge from the maternity unit. This will allow the sticky label to be available in the home environment for use by community midwives (for example) to enable unique identification of blood spot cards along the screening pathway.

VERSION HISTORY

Version

0.1

0.2

0.3

1.0 Final

1.1 Draft

1.2 Draft

2.0 Final

Version No: 3.3

Date Issued Brief Summary of Change

First Draft Version for comment

Second Draft Version after review comments received from NHS Numbers For

Newborn Screening Project Board

Third Draft Version after review comments received from Kate Hall and David

Isherwood

13 th July 2005 Updated to reflect sign-off by the UK

Newborn Screening Programme Centre

4 th July 2008 Updated for review as part of good practice by the UK Newborn Screening Programme

Centre

16 th July 2008 Updated second draft for review, with the amendment of PCT of Residence to now be

National GP Practice Code (where present); and other minor modifications.

21 st July 2008 Updated to reflect sign-off by the UK

Newborn Screening Programme Centre

Owner’s Name

Glen Woodward

Glen Woodward

Glen Woodward

Glen Woodward

Glen Woodward

Glen Woodward

Glen Woodward

Author:

Glen Woodward, Demographics Team

NHS Connecting for Health

Page 3 of 50

NHS Numbers for Newborn Screening NHS Newborn Blood Spot Screening Programme



Version

2.1 Final

2.2.1

3.0

3.1

3.2

3.3

3.4

Date Issued Brief Summary of Change

30 th April 2009 Updated with clarification of responsibility for label verification

20-May-2010 Updated image of new Blood Spot Test

Card

18 th February

2011

11

2011

5 th th August

November

2012

Updated with clarification on font size, baby’s usual address and organisation name

Further amendment to baby’s usual address guidance

Amendment to baby’s forename and surname guidance

17 th January

2014

17 th November

2014

Contact details

Contact details

Owner’s Name

James Couper-

Johnston

James Couper-

Johnston

Radhika Rajani

Radhika Rajani

Radhika Rajani

Jamili Miah

Jamili Miah

For more information on the status of this document, please see the covering letter or contact:

Jamili Miah


Public Health England

Zone B, 2nd Floor

Skipton House,

80 London Road,

London, SE1 6LH

Telephone +44 (0) 20368 20856

E-mail: Jamili.miah@nhs.net

Date of Issue

Reference

© Crown Copyright 2008

Version No: 3.3

17 th November 2014

NPFIT-FNT-TO-DPM-

0405.02._OBS_NN4NS_Blood_Spot_Card_v3.3

Author:



Page 4 of 50



CONTENTS



1.

INTRODUCTION ........................................................................................................... 7

S COPE

................................................................................................................................................................ 7

R EFERENCES ..................................................................................................................................................... 8

2.

STRATEGIC CONTEXT ................................................................................................ 9

B ACKGROUND

.................................................................................................................................................... 9

O BJECTIVES

..................................................................................................................................................... 12

3.

LABEL CONTENT AND FORMAT ...............................................................................14

C ONTENT O VERVIEW

....................................................................................................................................... 14

F ORMAT O VERVIEW

......................................................................................................................................... 31

4.

BAR-CODE CONTENT AND FORMAT .......................................................................35

O VERVIEW

........................................................................................................................................................ 35

5.

SYSTEM REQUIREMENTS .........................................................................................38

S YSTEM H ANDLING O F T HE B AR -C ODE

.......................................................................................................... 38

D IMENSIONS

..................................................................................................................................................... 38

S YMBOLOGY

..................................................................................................................................................... 38

6.

PRINTING REQUIREMENTS .......................................................................................39

C ODE S ETS

...................................................................................................................................................... 39

L ABEL P AGE F ORMATS

.................................................................................................................................... 39

7.

BAR-CODE VERIFICATION ........................................................................................40

Version No: 3.3 Author:



Page 5 of 50




V ERIFICATION O VERVIEW ................................................................................................................................ 40

V ERIFICATION P ROCESS .................................................................................................................................. 40

T ESTING PROCESS (S UPPLIERS ) M ATERNITY S YSTEM S UPPLIERS ............................................................. 41

T ESTING P ROCESS (U NITS ) M ATERNITY U NIT I NFORMATION S YSTEM I NSTALLATIONS .............................. 43

T ESTING PROCESS (L ABORATORIES ) S CREENING L ABORATORY S YSTEM S UPPLIERS ............................... 45

APPENDIX A - BLOOD SPOT LABEL SIGN-OFF FORM (P1) ...........................................47



Version No: 3.3

Page 6 of 50

Author:





1. INTRODUCTION



Scope

This is the Output Based Specification (OBS) for the production of ‘standard sticky labels’ so as to enable all maternity units to print such labels with the NHS number both in numeric

‘3-3-4’ format and as a linear bar-code (Reference 1).

To ensure that the specification can be adequately followed, the table of References below details the relevant documents that are required.

This OBS will be read by a number of differing system supplier communities (including

Maternity System and Screening Laboratory System Suppliers) as well as being used by the

UK Newborn Screening Programme Centre as the technical reference for the NHS Numbers

For Newborn Screening Project.

It is strongly recommended that ALL System Suppliers read and comply with ALL sections of the specification, as detail regarding the label design is important to all supplier communities.

This document will also be the basis for more detailed guidance from the UK Newborn

Screening Programme Centre regarding the implementation and training requirements of the

Health Care Professionals, such as :



the midwifery community



laboratory staff



nurse specialists

Relating to the above point, this document does NOT detail such guidance on implementation, roll-out and training requirements.

Version No: 3.3

Page 7 of 50

Author:







References

Reference Title

1

Notes:

2

3

4

5

6

7

Version

The Format of the NHS Number in

NHS systems

Version 1.0

NN4B Birth Notification Data Set Version 4.0

NN4B Maternity System Specification Version 5.1

Version 5.0 NN4B Message Specifications -

Maternity – CIS

NHS Data Dictionary Version 3

GS1 General Specifications V8.0

Birth Notifications BUC

Version 8.0,

Issue 2

Version 4.0

Date

14/11/2005

10/08/2001

01/12/2007

06/10/2005

May 2008

May 2008

04/12/2007

Some of the above hyperlinks require a connection to N3 (nww access).

Please contact the author if any of the documents cannot be obtained (i.e. are not hyperlinked / not able to connect to N3 website).

Version No: 3.3

Page 8 of 50

Author:





2. STRATEGIC CONTEXT



Background

The National Screening Committee recommends that all babies are screened for phenylketonuria, congenital hypothyroidism, sickle cell diseases, cystic fibrosis and medium-chain acyl-CoA dehydrogenase deficiency. It is important that all health care professionals are aware of which conditions are screened for in their area.

The blood spot screening test is performed by pricking the heel of the baby’s foot and dropping the blood obtained onto a special filter paper card where it is dried as several blood spots.

These blood spots are sent to a newborn screening laboratory where they undergo a number of tests with the aim of picking up babies with illnesses or conditions that would benefit from early treatment.

One problem for this programme has been tracking babies through the system to make sure they have been tested. Until now, this has only been possible by using names and other personal identifiers because the NHS number was typically not available at the age when screening was carried out (5-8 days).

However, the introduction of NHS Numbers For Babies in October 2002 has made it possible for tracking to be based on the NHS number because babies are now given their unique identifier shortly after birth. Newborn screening is now carried out on day 5-8 (ideally day 5).

The UK Newborn Screening Programme Centre is working with the Sickle Cell and

Thalassaemia Screening Programme, the UK Newborn Screening Laboratories Network

(UKNSLN) and NHS Connecting for Health to ensure that the benefits of early issue of NHS numbers to babies extend to newborn screening. Specifically, to ensure that the blood spot label is compliant with the newborn screening filter paper test card, and that the delivered blood spot samples meet current laboratory standards and practices.




Page 9 of 50





The UKNSLN was instrumental in developing and agreeing the blood spot card label design in February/March 2003, This OBS builds on this work by utilising the NHS Numbers

For Babies Birth Notification Dataset (section 3 refers).

It is the intention that both the technical processes and over-riding procedures put in place to enable NHS Numbers for Newborn Screening will be implemented within the architecture of the National Programme for Information

Technology (NPfIT). Figure 1 illustrates both the current and future flows of birth data, incorporating the introduction of the blood spot screening label - production of which has been mandated as part of the Maternity System

Compliance criteria from the 2008-A NHS CRS release onwards.

Version No: 3.3

Page 10 of 50

Author:





UK Newborn Screening Programme Centre


Figure 1: Birth Notifications From November 2007

0601

0806 eSP

Hearing

Screening

ONS MHS-

Life Events

RON

0516

(until ONS MHS becomes

NHS CRS-compliant)

NHS CRS

Maternity

System

0816

Blood Spot

Screening Label

0801

0804

0815

0802

0515

(until eSP becomes

NHS CRS-compliant)

0504

NN4B

CIS

0517

0805

NHS CRS

SPINE

0503

0501

Maternity

System

0502

Maternity

INNS

0505

CTL data to

NHS CR

0514

NSTS

0811

0812

0813

0506 0816 0513

0814

0506

Version No: 3.2

0508

Child Health

(Responsible if different)

Child Health

(Partner)

0509

0509

0507

(until RON goes live)

Parent(s)

and Child(ren)

0510

Blood Spot

Screening Label

Registrar of

Births & Deaths

0511

CHRIS

NHS CR

0512

M204 ONS

Titchfield

Author: Glen Woodward, NHS Connecting for Health; Version 4.0 dated 4 th

Dec 2007; VisioDocument - Release 2008-A.

Page 11 of 50

0807

(until RON goes live)

0810

0809

Legend:

05xx

06xx

08xx

0803

NHS CRS

Child Health

(Partner)

0808

NHS CRS

Child Health

(Responsible if different)

2005-5 Flows

2006 Flow

2008-A Flows

NHS CRS

SDS

NHS CRS eSP

Hearing

Screening

NHS CRS

ONS MHS-

Life Events

RON

NHS CRS

PSIS

NHS CRS

SUS

Author:


BT NHS


Service



Objectives



The objective of this project is to make sure that the screening laboratory receives the blood spot filter paper test card (Figure 2) with the NHS Number represented as a linear barcode as well as in an eye-readable format, and also basic birth and demographic details on a label.

Figure 2 - An example filter paper test card.

Specifically, the aim is to enable all maternity un its to print ‘standard sticky labels’ with the NHS number to give to the mother with the personal child health record (PCHR), usually before discharge from the maternity unit.

The label will include some birth and demographic information from the birth notification data set as well as the NHS number. This is necessary so that all users of the test card (both midwives and laboratories) have as much personal demographic details about the patient

(baby) to ensure as far as possible that the correct labels are being attached to the relevant sample or to facilitate management of screening in the event of IT failures.

The labels will bring about enormous benefits. Midwives will use these labels when they carry out the newborn blood spot test. Hence, they will not have to handwrite all the basic birth and demographic details, thus saving time and reducing errors on both the writing and




Page 12 of 50




UKNSLN / NHS Connecting for Health reading stages. Benefit of reducing data transcription error in laboratories will also result. It is recognised, however, that parent(s) do move, and in such cases, demographic details will need to be manually updated when required.

The use of bar-coded labels will enable the NHS number to be used as a unique identifier within the screening process and be able to track babies throughout the system.

Being able to correctly identify and track the progress of babies is fundamental to reducing the risk of babies going untested or not being tested in a timely fashion.

Version No: 3.3

Page 13 of 50

Author:





3. LABEL CONTENT AND FORMAT



Content Overview

The contents of the label are derived from the existing NN4B Birth Notification Data Set

(Reference 2).

As a result of the data items being derived from the above data set, then the validation for the data items detailed in this section of the specification MUST be consistent with the validation detailed in the NN4B Birth Notification Data Set. As an example, baby’s surname cannot be mandated in the following data set as it is set as optional in the NN4B dataset.

If data items are present in the Birth Notification raised, then, if the data items appear in table 1, such data items MUST be printed on the label. Again, using the optional data item of baby’s surname (in the NN4B Birth Notification Data Set) …

 if baby’s surname is present on the NN4B Birth Notification Data Set, then it MUST be printed on the label

 if baby’s surname is not present on the NN4B Birth Notification Data Set, then, by default, the baby’s surname cannot be printed.

The data items, together with their format and status are detailed in table 1.

Notation used in table 1



Field Description - description of the data item.



Defined in NHS Data Dictionary - Yes or No. (Data items marked with *

(asterisk) are present in the NHS Data Dictionary but have a format that differs from the NHS Data Dictionary definition.



Status - The status identifies if the data is



M (mandatory - must be present in the message)




Page 14 of 50






R (required - must normally be present but exceptional circumstances may prevent it)



O (optional - does not have to be present in the message but should be included by the sending system if available)



C (conditional - a rule specifying the circumstances in which the data must be present in the message. Details will be given in the

Validation/Notes column)

 n/a (not applicable to this message transaction)



Format

 a – alphabetic characters (letters a-z, A-Z, the <space> character, and all punctuation characters). Invalid characters are default HL7 delimiters and separators which are |^~\& (pipe, circumflex, tilde, backslash, ampersand)

 n – numeric characters (values 0-9 only)

The form of representation that the data may take, according to the following notation:



a3 3 alphabetic characters, fixed length



n3 3 numeric characters, fixed length



an3 3 alpha-numeric characters, fixed length



a..3 up to 3 alphabetic characters



n..3 up to 3 numeric characters



an..3 up to 3 alpha-numeric characters

Version No: 3.3

Page 15 of 50

Author:








Validation/Notes - any conditions attached to the formatting etc.

Version No: 3.3

Page 16 of 50

Author:







Table 1 - Blood Spot Card Label Data Items (derived from the NN4B Birth Notification)

Field

Description

Bar-coded

NHS

Number

Defined in

NHS Data

Dictionary

Status Format Validation/Notes

ISB Approved –

Operational

Requirement

Standard.

Mandatory

(subject to

NHS Number being available at point of printing labels). If not issued, then blank field

GS1-128 bar-code symbology

(defined later in this document)

The GS1 specifications state that the human readable should always appear but if space does not allow, or if there are other business reasons, it may not be necessary for the human readable to appear under the bar-code.

Therefore, as the numeric

NHS Number is also a mandated field (subject to the condition mentioned below), then, in the case of a non-scan, the 10 digit

NHS Number would therefore be keyed in.

NHS

Number

(baby)

Yes Mandatory

(subject to

NHS Number being available at point of printing labels). If not issued, then field must read ‘ NOT n10 See Reference 3.

Specifically Section 7.1.3.

The NHS number comprises 10 digits. The first nine are the identifier and the tenth is a check digit used to confirm the number's validity. The check digit is calculated using the Modulus 11




Page 17 of 50



Field

Description

Defined in

NHS Data

Dictionary

Status

OBTAINED

’



Format Validation/Notes algorithm

The NHS Number MUST be printed in 3-3-4 format on all labels e.g. 123 456 7890

Baby’s

Surname

Yes Optional an..35 Notifications of birth submitted by Spinecompliant systems will populate the baby’s surname with a default name if entered as a null field - this being the mother’s surname.

Baby’s First

Forename

Yes Optional an..35 Notifications of birth submitted by Spinecompliant systems will populate the baby’s forename with a default name if entered as a null field - this being ‘Baby’ for a singleton, and the named equivalent including the multiplicity if a multiple birth i.e

. ‘Twin One’, ’Triplet

Three’ etc.

Birth Date

(baby)

Yes Mandatory n8 (an10 with

CCYYMMDD

Formatted to be




Page 18 of 50



Field

Description

Defined in

NHS Data

Dictionary

Status



Format Validation/Notes separators) viewed/printed as dd mm ccyy . Date separator can be one of /.- (forward slash

(ASCII 47), full stop (ASCII

46), hyphen (ASCII 45))

Sex Yes Mandatory an..13 Not known

Male

Female

Not specified

Note that the label MUST show the text equivalent

(as detailed above) and not the coded version.

Baby’s Usual

Address line

1

Yes

Baby’s Usual

Address line

2

Yes

Baby’s Usual

Address line

3

Yes

Conditional

Conditional

Optional an..35 an..35 an..35

Either address line 1 or address line 2 must be present

Either address line 1 or address line 2 must be present

Optional an..8 Postcode of

Baby’s Usual

Yes




Page 19 of 50



Field

Description

Defined in

NHS Data

Dictionary

Status



Format Validation/Notes

Address

Birth Weight

(grams)

* Yes

The NHS Data

Dictionary states:

Mandatory n4

The baby's weight in grams between 0001 to 9998 grams with a Default

Code of 9999 -

Not known

Ethnic

Category

(baby)

Defined by mother, required for monitoring of service delivery

Yes Mandatory an2

Allowable range from

‘0000’ (zero) to ‘9999’

Zero (‘0000’) and ‘9999’ both indicate not weighed

To prevent the potential for the weight to be misread, the birth weight MUST be printed as 4 numerics for births under 1000g with the first digit being a leading zero i.e. the values ‘950’ MUST be printed as ‘0950’

The recommended classification is a single character defined from within the range A to Z and this should be stored in the first position of the field.

(There is a further optional level of classification consisting of an additional character which may be used at local level if required)

White




Page 20 of 50



Field

Description

Defined in

NHS Data

Dictionary

Status




A = British

B = Irish

C = Any other White background

Mixed

D = White and Black

Caribbean

E = White and Black

African

F = White and Asian

G = Any other mixed background

Asian or Asian British

H = Indian

J = Pakistani

K = Bangladeshi

L = Any other Asian background

Black or Black British

M = Caribbean

N = African

P = Any other Black




Page 21 of 50



Field

Description

Defined in

NHS Data

Dictionary

Status



Format Validation/Notes background

Other ethnic groups

R = Chinese

S = Any other ethnic group

Z = Not stated

Version No: 3.3

Page 22 of 50

Author:





Field

Description

Defined in

NHS Data

Dictionary

Status




Birth Order

(if multiple)

* Yes

The NHS Data

Dictionary states:

This records the sequence in which the baby was born, with

1 indicating the first or only birth in the sequence

(i.e. singleton),

2 indicating the second birth in the sequence, 3 indicating the third, and so on with Default

Codes of

8 - Not applicable

9 - Not known: a validation error

Conditional n1 Must be present if ‘Number of births in this confinement’ is greater than 1

Allowable range from ‘1’ to

‘9’

This data item will be combined with ‘Number of births in this confinement’ to produce the term of rank

Rank will be defined by the following notation:

Rank -

Birth Order/No. of births this confinement

- with the separator being /

(forward slash (ASCII 47)) i.e. Rank: 2/3




Page 23 of 50



Field

Description

Defined in

NHS Data

Dictionary

Status




- meaning the second birth out of three this confinement

For systems that do not record birth order for a singleton birth, then the field of rank MUST include a default of ‘1’ for birth order i.e. although birth order can be null for a singleton birth, the rank MUST default to

Rank: 1/1

Version No: 3.3

Page 24 of 50

Author:





Field

Description

Defined in

NHS Data

Dictionary

Status




Number of births in this confinement

Gestation

Length

* Yes

The NHS Data

Dictionary states:

The following values with the addition of the

Default Code, can be used:

1 - One

2 - Two

3 - Three

4 - Four

5 - Five

6 - Six or more

Default Code of

9 - Not known: a validation error

* Yes

The NHS Data

Mandatory

Mandatory n1 n2

Allowable range from ‘1’ to

‘9’

This data item will be combined with ‘Birth Order’ to produce the term rank

Rank will be defined by the following notation:

Rank -

Birth Order/No. of births this confinement

- with the separator being /

(forward slash (ASCII 47)) i.e. Rank: 2/3

- meaning the second birth out of three this confinement

Allowable range includes

‘00’ (zero) and from ‘10’ to

‘49’




Page 25 of 50



Field

Description

Defined in

NHS Data

Dictionary

Status




(weeks) Dictionary states:

Gestation

Length records a period (if known) of between 10 to

49 weeks with a

Default Code of

99 - Not known

Yes Mandatory an..35

Zero (‘00’) and ‘99’ both indicate unknown gestation length

If the local maternity system enables data capture for the number of days as well as the number of weeks, then this MUST be included - section 3.2.4 refers

Mother’s

Surname

Mother’s

First

Forename

Yes Mandatory an..35

Birth Date

(mother)

Yes Conditional

To be printed

ONLY if NHS

Number

(mother) is

NOT present on the birth notification n8 (an10 with separators)

MUST be present if

Mother’s NHS Number is blank

CCYYMMDD

Formatted to be viewed/printed as dd mm ccyy . Date separator can be one of /.- (forward slash




Page 26 of 50



Field

Description

Defined in

NHS Data

Dictionary

Status






If both Birth Date (mother) and NHS Number (mother) are present on the birth notification, then the mother’s NHS Number

MUST be printed in preference to the mothers’ date of birth

NHS

Number

(mother)

Yes Conditional

To be printed if NHS

Number

(mother) is present on the birth notification n10 The NHS number comprises 10 digits. The first nine are the identifier and the tenth is a check digit used to confirm the number's validity. The check digit is calculated using the Modulus 11 algorithm

The NHS Number MUST be printed in 3-3-4 format on all labels e.g. 123 456 7890

If both Birth Date (mother) and NHS Number (mother) are present on the birth notification, then the mother’s NHS Number




Page 27 of 50



Field

Description

Defined in

NHS Data

Dictionary

Status




MUST be printed in preference to the mothers’ date of birth

GP Name

National GP

Practice

Code

Organisation

Name

Yes

Yes

Yes

Conditional an..35

Conditional

This MUST be populated as part of

NHS CRS compliance

Conditional an6 an..35

MUST be present if

National GP Code is blank

MUST be present if GP

Practice Name is blank

If a non NHS CRS compliant system supports this data item, and it is populated on a notification, then it MUST be printed

MUST be present if the

Delivery Place Type Code is one of:

0 = In NHS hospital - delivery facilities associated with midwife ward

2 = In NHS hospital - delivery facilities associated with consultant ward

3 = In NHS hospital -




Page 28 of 50



Field

Description

Defined in

NHS Data

Dictionary

Status



Format Validation/Notes delivery facilities associated with GMP ward

4 = In NHS hospital - delivery facilities associated with consultant/GMP/midwi fe ward inclusive of any combination of two of the professionals mentioned

5 = In private hospital

6 = In other hospital or institution

7 = In NHS hospital - ward or unit without delivery facilities

Version No: 3.3

Page 29 of 50

Author:





Field

Description

Defined in

NHS Data

Dictionary

Status




Date Printed N/A Mandatory n8 CCYYMMDD

This is the date that the labels were printed

Formatted to be viewed/printed as dd mm ccyy . Date separator can be one of /.- (forward slash



Version No: 3.3

Page 30 of 50

Author:





Format Overview



The format of the label design is as in Diagram 1

The font size MUST be a minimum of size 8

Diagram 1 - Blood spot Label Design (not to scale)

All the data fields are shown for clarity. If data items are optional/conditional and are not present as pa rt of the NN4B Birth Notification (e.g. baby’s surname), then the field should remain blank.

NHS No: 999 000 5451

Version No: 3.3

Baby Surname, Forename

Address lines 1, 2 and 3

Birth Weight (g)

Rank: Birth Order/No. Births

Mother Forename, Surname

GP name

Name of Hospital where born

Date of Birth Sex

Postcode

Ethnic Category (Baby)

Gestation Length (weeks/days)

Mother NHS Number/DoB

National GP Practice Code

Label printed on: Date

Printed

National Practice Code

Author:



Page 31 of 50





The data fields (underlined in the above diagram for illustrative purposes only and should not be printed as being underlined on the label) MUST have a text description preceding the field as follows:



NHS No:



Rank:



Label printed on:

Data fields requiring units (Birth Weight and Gestation length) MUST include the units following the field. Examples are:



3175 g - birth weight



40 weeks - gestation length

Version No: 3.3

Page 32 of 50

Author:







For systems that provide enhanced functionality for the data items referred to in 3.2.3 (i.e. imperial equivalents for weight; inclusion of days for gestation length) then this may be added to the design so long as it is an already recognisable label convention such as:



3175 g (7lb 0oz)



40 + 0 weeks

Mother NHS Number/DoB:



where a birth is notified to the Central Issue System which contains the

Mothers’ NHS Number, then the Mother’s NHS Number MUST be printed

(in 3-3-4 format) in preference to the mothe r’s date of birth.



where a birth is notified to the Central Issue System which DOES NOT contain the Mothers’ NHS Number, then the Mother’s Date of Birth shall be printed.

Address:



a lthough ‘Baby’s Usual Address line 1’ is conditional, if this is insufficient to locate a baby e.g. only depicts house name or flat number, then ‘Baby’s

Usual Address line 2

’ MUST be included. Where Address Line 3 is present this should also be printed on the label.

Organisation name:

 for the purpose of identifying a baby, the ‘organisation name’ MUST be the name of the Maternity Unit , not the NHS Trust.

Baby’s Surname and Forename:



the full surname and full (first) forename should be printed on the label.




Page 33 of 50






if space prevents the above, then the surname MUST be printed in full

(again where possible) in preference to the forename – but as much of the forename that can be printed MUST also be printed.



if space then prevents this, then as much of the surname MUST be printed

Version No: 3.3

Page 34 of 50

Author:







4. BAR-CODE CONTENT AND FORMAT

Overview

Table 2 - Format of the Element String*

Version No: 3.3

Format of the Element String

Global Service Relation Number (GSRN) Application

Identifier

8018

GS1 Company Prefix Service Reference

N

1

N

2

N

3

N

4

N

5

N

6

N

7

N

8

N

9

N

10

N

11

N

12

N

13

N

14

N

15

N

16

N

17

Check

Digit

N

18

*

Referenced from http://www.gs1uk.org/downloads/standards/GS1%20General%20%20Specifications.pdf

- p.131

Notes:

Application Identifier (format of 4 numerics) - ‘ 8018 ’ - relates to a Service

Relation Number (SRN) and indicates that the data field contains a Global

Service Relation Number (GSRN).

GS1 Company Prefix - UK Health and Social Care (format of 7 numerics) -

‘ 5050898 ’ allocated to the Service Provider (the NHS) and it makes the number (the NHS Number) GLOBALLY UNIQUE .

Service Reference (format of 10 numerics) - the NHS Number.

Check Digit (format of 1 numeric) - check digit and its verification, which must be carried out in the application software, ensures that the number is correctly composed. Details of the check digit calculation are available from

Author:



Page 35 of 50




UKNSLN / NHS Connecting for Health http://www.gs1uk.org/downloads/standards/GS1%20General%20%20Spe cifications.pdf

- p.408 refers.

Version No: 3.3

Page 36 of 50

Author:





OBS - Blood spot label e.g. element string ‘ 8018505089899900054513 ’ comprises …

‘ 8018 ’ - Application Identifier

‘ 5050898 ’ - GS1 ‘Company’ Prefix - UK Health and Social Care

Number (NHS Number)

‘ 9990005451 ’ - NHS Number 999 000 5451

‘

3

’ - Check Digit

System providers should refer the GS1 general specifications

( http://www.gs1uk.org/standards/general_specs.asp

) to enable the production of GS1 compliant GS1-128 and datamatrix.

Version No: 3.3

Page 37 of 50

Author:





5. SYSTEM REQUIREMENTS



System Handling Of The Bar-Code

As the bar-coded NHS Number is a 22-digit element string, then systems will have to both validate and process the new format by …



recognising and discarding the application identifier (positions 1 to 4)



recognising the GS1 Company Prefix (positions 5 to 11)



validating the bar-code check-digit (position 22) - this validation is done by the scanner. The check digit is not sent by the scanner to the host system



returning the 10-digit NHS Number (positions 12 to 21)

Dimensions

The minimum dimensions quoted by the e.centre for the GS1-128 bar-code are

46.7 mm long by 12 mm deep.

Specifically, the minimum symbol height indicated is for bar height only and does not include the Human Readable Interpretation. If the item is too small to accommodate the minimum, the minimum bar height is the greater of 15 percent of the symbol width including Quiet Zones or 12.7 mm (0.50 in.).

Symbology

The data carrier for the Global Service Relation Number (GSRN) is the GS1-128

Bar-Code Symbol. When encoding the GSRN, the GS1-128 Bar-Code Symbol should be printed at an X-dimension between 0.25 mm (0.00984 in.) and 1.016 mm

(0.040in.).

Version No: 3.3

Page 38 of 50

Author:





6. PRINTING REQUIREMENTS



Code Sets

As the data encoded within the bar-code is purely numeric, then GS1-128 Code set

C MUST be used so as to ensure minimum printed bar-code length. The standard operation procedure specifies a minimum of 9 labels per baby to be produced.

The data carrier for the Global Service Relation Number (GSRN) is the GS1-128

Bar-Code Symbol. When encoding the GSRN, the GS1-128 Bar-Code Symbol should be printed at an X-dimension between 0.25 mm (0.00984 in.) and 1.016 mm

(0.040in.).

Label Page Formats

Due to the multitude of label sheets, and also the myriad printers available, this specification cannot specify a particular type of label sheet or printer.

However, examples of some of the more popular label sheet formats in use are:



Avery A4 - L7160 - giving 21 labels (3 across by 7 down)



Avery A4 - L7161 - giving 18 labels (3 across by 6 down)

The following measurements are a guide as to the minimum and maximum label sizes recommended by the UKNSLN so as to be able to fit on the blood spot card:



Minimum dimensions: 6.35 cm wide by 3.81 cm deep



Maximum dimensions: 8.89 cm wide by 5.08 cm deep

Version No: 3.3

Page 39 of 50

Author:





7. BAR-CODE VERIFICATION



Verification Overview

Verification is the measuring and grading of the quality of a printed bar-code in its final configuration. This is carried out to international standards and is particularly useful for quality control purposes.

The difference between symbol verification and symbol scanning is that verification measures and grades the quality of a bar-code, and can provide information to help diagnose the cause of any problems. Scanning is the process of reading the data from the symbol and it provides no indication of a barcode’s quality.

Verification Process

Any verifier used to check the quality of GS1 bar-codes should conform to the international standard ISO/IEC 15426-1, which will ensure that the codes are graded according to the standard ISO/IEC 15416.

The international specification for bar-code print quality (ISO/IEC 15416) defines seven attributes.

For each scan the verifier produces an individual reflectance profile which measures the reflectance of each bar and space of the bar-code. The verifier then takes nine different measurements from the reflectance profile, and grades seven of them individually.

The grade for the scan of the bar-code will be the lowest grade for any one of these seven parameters. The overall symbol grade is obtained by averaging the grades of the ten individual scan reflectance profiles.

Each parameter is measured in percentage terms and this is then expressed as a numeric or alphabetic grade. The numeric grade will provide more precise figures, but as the alphabetic grades are still widely used a table showing how they compare is set out below:




Page 40 of 50





Table 3 - Table relating numeric grading to alphabetic grading

Alphabetic Numeric range

A

B

C

D

F

3.5 - 4.0

2.5 - 3.5

1.5 - 2.5

0.5 - 1.5

0 - 0.5

All GS1-128 bar-codes must have a grade of C (1.5) or better. In general symbols with higher quality grades can be expected to scan more easily and quickly than lower quality symbols of the same magnification. Larger magnification, the absence of truncation, and high print quality contribute to fast, effortless scanning.

Bar-codes that fail verification may scan under ideal conditions, but badly or not at all in other environments. This is why a scanner cannot be used to test the quality of a bar-code.

Testing process (Suppliers) - Maternity System Suppliers

Version No: 3.3

Once the System Supplier has developed their system to enable the functionality detailed in this specification, the Supplier will follow this process to secure verification of conformity of the label output.

Submit sample output labels to a verification authority to achieve certification of verification as described above in Verification Overview and Verification Process.

(The UK Newborn Screening Programme Centre has the required verification equipment and will act as Verification Authority if required, otherwise labels should

Author:



Page 41 of 50




UKNSLN / NHS Connecting for Health be submitted to a recognised commercial body and the necessary fees paid to achieve certification.)

The following documentation should then be submitted to the UK Newborn

Screening Programme Centre as official confirmation that the System is able to print bar-coded NHS Number labels from their system.



Written confirmation (on headed paper) from the supplier that bar-coding functionality has been implemented on the system



Written confirmation (on headed paper) of the verification process detailed in

Section 7, together with written certification of their grading, together with details (make, model) of the verifier used.



Appendix A contains the sign-off form that MUST be completed by all parties detailed within the document.

All the above MUST be sent on completion to:

Version No: 3.3

Jamili Miah



Zone B, 2nd Floor

Skipton House,

80 London Road,

London, SE1 6LH

- or e-mail it to Jamili.miah@nhs.net

Please note that if any patient identifiable data (PID) is sent through the post (i.e. sample labels sent for verification), then this MUST be sent through using secure mechanisms ensuring the continued confidentiality of patient data.

Author:



Page 42 of 50





If sending PID via email, please note that the sending email address MUST be sent from an NHSmail account to the email address stated above.

Copies of Appendix A will be sent to all parties as part of the Project Testing process.

Testing Process (Units) - Maternity Unit Information System Installations

Once the System Supplier has upgraded the installation in the Maternity Unit, the local representatives should follow this process to achieve certification of the installation at local level.



Submit sample output labels using the specific dedicated printer in the

Maternity Unit to a verification authority to achieve certification of verification as described above in Verification Overview and Verification Process. (The

UK Newborn Screening Programme Centre has the required verification equipment and will act as Verification Authority if required (at no cost to the

User), otherwise labels should be submitted to a recognised commercial body and the necessary fees paid to achieve certification).



Submit sample output labels to the UK Newborn Screening Programme

Centre for content and layout certification in accordance with Section 3 Label

Content and Format above detailing the mandatory minima of information required to be included and the specified layout of the information fields.

There is no requirement to submit labels to the local Screening Laboratory since compliance for interpretation and import of information will be achieved separately.


Jamili Miah





Page 43 of 50




Zone B, 2nd Floor

Skipton House,

80 London Road,

London, SE1 6LH




Version No: 3.3

Page 44 of 50

Author:







Testing process (Laboratories) - Screening Laboratory System Suppliers

Once the System Supplier has developed their system to enable the scanning functionality detailed in this specification, the Supplier will submit the following documentation as official conformation that the System is able to read and correctly interpret bar-coded NHS Number labels.



Written confirmation (on headed paper) from the supplier that bar-coding functionality has been implemented on their system so as to successfully read the NHS Number bar-code and to populate the NHS Number field on the Screening Laboratory system.

Appendix A contains the sign-off form that MUST be completed by all parties detailed within the document.


Jamili Miah



Zone B, 2nd Floor

Skipton House,

80 London Road,

London, SE1 6LH


Version No: 3.3

Page 45 of 50

Author:







Copies of Appendix A will be sent to all parties as part of the Project Testing process.

Appendix A contains the sign-off form that MUST be completed.

Version No: 3.3

Page 46 of 50

Author:







APPENDIX A - BLOOD SPOT LABEL SIGN-OFF FORM (P1)

Trust Name

Maternity Site Name

Maternity System Supplier

Maternity System Name and Version

Screening Laboratory System Supplier

Screening Laboratory System Name and

Version

The above Maternity and Screening Laboratory Systems have been amended in accordance with the NHS Numbers for Newborn Screening Output Based Specification for the Blood spot label and have successfully completed to the satisfaction of all parties detailed in this document.

Such parties therefore consider the bar-coding software suitable for national implementation and recommends that unconditional/conditional approval status be granted.

Please include details of restrictions on page 3 if only conditional approval is recommended.

Version No: 3.3

Page 47 of 50

Author:








Midwifery Representative Name

Position

Signature

Date

Maternity System Supplier

Representative Name

Position

Signature

Date

Screening Laboratory System Supplier

Representative Name

Version No: 3.3

Page 48 of 50

Author:





Position

Signature

Date

On behalf of the NHS Connecting for

Health

Position

Signature

Date



Version No: 3.3

Page 49 of 50

Author:








Details of Restrictions

5.

6.

2.

3.

Item for Amendment

1.

4.

Target Date for completion

Version No: 3.3

Page 50 of 50

Author:



Output Based Specification for the Blood Spot Card Label

NHS Numbers for Newborn

Screening

Output Based Specification for the Blood Spot Card Label

Version No: 3.4

Issue Date: 17

November 2014

CONTENTS

1. INTRODUCTION

2. STRATEGIC CONTEXT

3. LABEL CONTENT AND FORMAT

4. BAR-CODE CONTENT AND FORMAT

5. SYSTEM REQUIREMENTS

6. PRINTING REQUIREMENTS

7. BAR-CODE VERIFICATION

APPENDIX A - BLOOD SPOT LABEL SIGN-OFF FORM (P1)

APPENDIX A - BLOOD SPOT LABEL SIGN-OFF FORM (P2)

APPENDIX A - BLOOD SPOT LABEL SIGN-OFF FORM (P3)

Related documents

Products

Support

Output Based Specification for the Blood Spot Card Label

NHS Numbers for Newborn

Screening

Output Based Specification for the Blood Spot Card Label

Version No: 3.4

Issue Date: 17

November 2014

CONTENTS

1. INTRODUCTION

2. STRATEGIC CONTEXT

3. LABEL CONTENT AND FORMAT

4. BAR-CODE CONTENT AND FORMAT

5. SYSTEM REQUIREMENTS

6. PRINTING REQUIREMENTS

7. BAR-CODE VERIFICATION

APPENDIX A - BLOOD SPOT LABEL SIGN-OFF FORM (P1)

APPENDIX A - BLOOD SPOT LABEL SIGN-OFF FORM (P2)

APPENDIX A - BLOOD SPOT LABEL SIGN-OFF FORM (P3)

Related documents

Add this document to collection(s)

Add this document to saved

Suggest us how to improve StudyLib