NHS Newborn Blood Spot Screening Programme: Laboratory
NHS Newborn Blood Spot Screening Programme: laboratoryquality assurance evidence requirementsISO15189ISORequirementNHS newborn blood spot screening: laboratory quality assurancerequirements1,2,3Introductory sections - As ISO 151894.MANAGEMENT REQUIREMENTS4.1Organisation and managementExamples ofevidence to beassessed4.1.1.3d Treatment ofhumanspecimensThe laboratory must handle blood spots according to the Code of Practice forthe Retention and Storage of Residual Newborn Blood Spots.Policy / SoP forretention andstorage ofblood spots4.1.1.4The newborn screening laboratory must have a named clinical lead andmanagement structure for screening.Job descriptionfor namedclinical leadand any otherscreening staff.LaboratorydirectorThe clinical lead must be the Newborn Screening Director. The clinical leadmust be a Fellow of the Royal College of Pathologists.Organogram showingscreening roles andlinks to accountability /responsibility /governance structurewithin organisation
ISO15189ISORequirementNHS newborn blood spot screening: laboratory quality assurancerequirementsExamples ofevidence to beassessed4.1.2.1ManagementresponsibilityThe laboratory must have a viable contingency plan for screening, to continuethe provision of newborn blood spot screening in the event of any failures tothe laboratory service.Business continuityplan / Emergency plan/ Business contingencystandard operatingprocedure or policyEvidence that this planhas been tested4.1.2.1ManagementresponsibilityThe laboratory must participate in the cross-organisational and multidisciplinary arrangements for the governance, management, communicationand development of the screening pathway. This must include: having clear communication arrangements with users and commissionersof the service, midwifery, GPs, health visiting, child health records andtreatments services sharing information on laboratory screening performance, quality indicatorsand incidents4.2.Quality management system4.2.1GeneralrequirementsThe laboratory quality management system must incorporate all the laboratoryrequirements for newborn bloodspot screening.The laboratory must have documented standard operating procedures for thefollowing processes, agreed with relevant services, for how screeningspecimens are monitored and managed. These must include identifiedresponsibilities and failsafe arrangements. receiving and processing specimens to enable matching these against theAgenda / minutes /terms of reference /performance reports /incident outcomereports / action plansAll standard operatingprocedures fornewborn blood spotscreening undertakenwithin the laboratory
ISO15189ISORequirementNHS newborn blood spot screening: laboratory quality assurancerequirementsExamples ofevidence to beassessedcohort of babies for whom screening has been offered and accepted identifying and recording un-labeled or mislabeled specimens, andspecimens unsuitable for analysis, and requesting and receiving repeatspecimens making sure screen positive results are received by clinical services having an escalation process for where screening is incomplete4.3.Document control4.3DocumentControlThe screening laboratory must make sure that all documents required by thequality management system, including documents of external origin arecontrolled to make sure that there is no unintended use of obsoletedocuments.The following documents are expected to be controlled, as externaldocuments, as a minimum: NHS England. Serious Incident Framework NHS Screening Programmes. Managing Safety Incidents in NHSScreening Programmes NHS service specification for newborn blood spot screening NHS service specification for SCT NHS NBS Screening Programme. Cystic fibrosis: screening laboratoryhandbook NHS NBS Screening Programme. Congenital hypothyroidism: screeningScreenshots /evidence of listeddocuments within QMS
ISO15189ISORequirementNHS newborn blood spot screening: laboratory quality assurancerequirementsExamples ofevidence to beassessedlaboratory handbook NHS NBS Screening Programme. Laboratory guide for inherited metabolicdiseases NHS SCT Screening Programme. Handbook for newborn laboratories NHS NBS Screening Programme. Failsafe procedures NHS NBS Screening Programme. Standards NHS SCT Screening Programme. Standards NHS Screening Programmes. Key Performance Indicators (KPIs):submission guidance and data definitions NHS NBS Screening Programme. Code of Practice for the Retention andStorage of Residual Newborn Blood Spots NHS Numbers for Newborn Screening: Output Based Specification for theBlood Spot Card Label NHS NBS Screening Programme. Guidelines for Newborn Blood SpotSampling NHS NBS Screening Programme. Newborn Blood Spot Status Codes4.4.Service agreements4.4.1Establishment The laboratory must have documented signed and dated agreements and arisk assessed protocol that sets out the responsibilities and workingof servicearrangements for screening specimens sent to other laboratories.agreementsService levelagreements / riskassessment protocols /send away procedure
ISO15189ISORequirementNHS newborn blood spot screening: laboratory quality assurancerequirementsFor NBS the agreements must include arrangements for: confirming specimen receipt meeting laboratory turnaround times making sure that results of the investigations are returned to the referringlaboratory making an initial clinical referral for screen positive babiesExamples ofevidence to beassesseddocument / datasharing agreementsThese laboratories must be ISO 15189 accredited (or CPA accredited andworking to ISO 15189), and participate in ISO 17043 accredited EQAschemes.4.5Examination by referral laboratories - As ISO 151894.6External services & supplies - As ISO 151894.7Advisory services - As ISO 151894.8Resolution of complaints - As ISO 151894.9Non-conformitiesIdentificationand control ofnonconformitiesThe laboratory must make sure that the management of the identification andcontrol of non-conformities includes a review process for screening-relatednon-conformities.Incident management /non-conformity policydemonstrating link tolocal, NHS and PHEframeworks forscreening incidents.
ISO15189ISORequirementNHS newborn blood spot screening: laboratory quality assurancerequirementsExamples ofevidence to beassessedScreening non-conformities must be reviewed, managed and reportedaccording to local, NHS and PHE frameworks for screening incidents, inparticular the NHS England Serious Incident Framework and NHS ScreeningProgrammes Managing Safety Incidents in NHS Screening Programmes.4.10Corrective action – As ISO 151894.11Preventive action - As ISO 151894.12Continual improvement - As ISO 151894.13Control of records4.13.dRecord ofspecimenreceipt4.14Evaluation and audit4.14.1GeneralThe laboratory must have a documented evaluation and audit programme toNBS related audits.assess performance against screening standards and quality indicators, in lineAudit programme.with NBS Programme requirements. This must include audit of all the qualityindicators in 4.14.7.Minutes of meetingsthat audit is presentedat and any associatedaction plans.4.14.3Assessmentof userfeedbackThe laboratory must make sure that there are arrangements forcommunicating with laboratory service users in the screening pathway andThe laboratory must use the nationally agreed status code for blood spotscreening specimen receipt. NHS Numbers for Newborn Screening: outputbased specification for the blood spot card label.Service user surveys /feedback analysis /action plans.
ISO15189ISORequirementNHS newborn blood spot screening: laboratory quality assurancerequirementsExamples ofevidence to beassessedacting upon their feedback. The user group should reflect the communicationpathways and multi-disciplinary team working in the NBS screening pathway.4.14.54.14.6Internal auditRiskmanagementThe laboratory must undertake an annual vertical audit of the screeningpathway, from arrival of the specimen at the laboratory to receipt of screenpositive results by clinical services. The audit must be of a randomly selectedpositive specimen.Vertical audit.Associated actionplans.The laboratory must have a documented risk management policy for thelaboratory aspects of the screening programme describing the steps in thetesting pathway where errors could occur and the procedures taken tominimise the risk of the error occurring.Risk managementpolicy.Minutes of meetingsthat audit is presentedat and any associatedaction plans.This must be part of an overall risk management policy for the whole of thescreening programme, and include the laboratory interaction with otherservices in the screening pathway.4.14.64.14.7RiskmanagementThe laboratory must upload results to the national newborn blood spot failsafesolution within one working day of reporting.SoP for results uploadQualityindicatorsThe laboratory must comply with requirements for meeting and reporting NBSstandards and key performance indicators.KPI and annual datasubmissionsCollection of data to measure performance against programme standardsmust be reported annually to the programme by the mid July at the latest. KeyData sharingagreement
ISO15189ISORequirementNHS newborn blood spot screening: laboratory quality assurancerequirementsExamples ofevidence to beassessedPerformance Indicators (KPIs) must be reported quarterly between 2/3months of each quarter end.The laboratory must: meet NBS Standard 9 ‘Timely processing of CHT and IMD (excludingHCU) screen positive samples’. The proportion of CHT and IMD (excludingHCU) screen positive results available and clinical referral initiated within 3working days of sample receipt by the screening laboratory submit data for NBS Standard 3 ‘Barcoded NHS number label is includedon the blood spot card’ to support maternity reporting submit data for NBS Standard 4 ‘Timely sample collection’ to supportmaternity reporting submit data for NBS Standard 5 ‘Timely receipt of a sample in the newbornscreening laboratory’ to support maternity reporting submit data for NBS Standard 6 ‘Quality of the blood spot sample’ tosupport maternity reporting submit data for Standard 11 ‘Timely entry into clinical care’ to supportclinical care reporting submit data on SCT screen positive babies to the National CongenitalAnomalies and Rare Diseases Register4.15Management review4.15.1GeneralThe laboratory must include newborn screening as part of its managementreview of the quality management system.Management reviewdocument
ISO15189ISORequirementNHS newborn blood spot screening: laboratory quality assurancerequirementsExamples ofevidence to beassessedMinutes of meetingswhere reviewpresented and ratifiedfor sign off.5.TECHNICAL REQUIREMENTS5.1Personnel - As ISO 151895.2Accommodation & environment - As ISO 151895.3Equipment, reagents & consumables - As ISO 151895.4Pre-examination processes5.4.3a.Request forminformationThe laboratory must use paper or electronic data request fields which arecompliant with the minimum data fields required for the Programme. Thelaboratory must use the standard NBS card (or equivalent) as approved andreviewed by the NHS NBS Programme Blood Spot Advisory Group. Whereconsent is declined, the information currently must be handwritten on the card,as there is no specific field for recording ‘declines’.5.4.4Primaryspecimencollection andreportingBlood sampling guidelines (pre collection and collection) are nationallydetermined.Request form(scanned paper copyor screenshot ofelectronic request).
ISO15189ISORequirementNHS newborn blood spot screening: laboratory quality assurancerequirementsThe laboratory must use the nationally defined acceptance and rejectioncriteria for blood spot specimens.5.4.6.bCriteria foracceptance /rejection5.5Examination processes5.5.1Selection,verificationand validationof examprocessesScreening laboratories must define and use clear cut-off values to classifyscreen positive results. These will typically be those within the nationallyagreed screening protocols for testing set out in the appendices within theNBS laboratory handbooks. QC material for newborn screening Sickle cell and thalassaemia screening action values for tandem massspectrometry5.6Ensuring quality of examination ination processes5.7.2Storage,retention anddisposal ofThe laboratory must participate in ISO 17043 accredited EQA schemes, andmust be prepared to share their data on EQA performance to the PHE QAServices and NHS Screening Programmes.The laboratory must store, retain and dispose of blood spots in line with theCode of Practice for the Retention and Storage of Residual Newborn BloodSpots, including the separation of demographic information from the driedblood spot specimen.Examples ofevidence to beassessedLocal dissemination ofnational criteria, staffcompetency logs,education updatesessions.Test meetsrequirements detailedin laboratoryhandbook.EQA performance datareportsSoP for retention andstorage of samples
ISO15189ISORequirementNHS newborn blood spot screening: laboratory quality assurancerequirementsExamples ofevidence to beassessedclinicalspecimens5.8Reporting results5.8.3ReportcontentThe laboratory must use the newborn screening results status codes and subcodes for reporting results to child health records departments and thenational newborn blood spot failsafe solution.Where hard copy reports are issued these should include the followinginformation; identification of the laboratory that issued the report; identificationof conditions screened for; patient identification including NHS number anddate of birth; date of sample collection; specific comment when screening isdeclined; relevant status codes and sub-codes; other comments consistentwith laboratory handbooks; date and time of report. (This will differ from theISO 15189 data reporting requirements)5.9Release of results - As ISO 151895.10Information management - As ISO 15189Scanned / screenshotcopy of report
The laboratory quality management system must incorporate all the laboratory . in laboratory handbook. 5.6 Ensuring quality of examination results 5.6.3 Inter-laboratory comparisons The laboratory
A Guide for Newborn Care Providers. Table of contents Section 1 Background information 1.1 Introduction 1.2 NSO history 1.3 NSO contact information 1.4 Newborn screening essentials 1.5 Newborn screening timeline 1.6 Newborn screening results 1.7 List of disorders included in the NSO screening panel
4.4 Emerging and re-emerging infections 43 4.5 Clinically insignificant transfusion-transmissible infections 44 5 Blood screening, quarantine and release 45 5.1 Blood screening process 45 5.2 Approaches to blood screening 45 5.3 Pooling for serological assays 47 5.4 Sequential screening 47 5.5 Blood screening and diagnostic testing 48 5.6 Emergency screening 48 5.7 Screening plasma for .
Practitioner's Newborn Screening Responsibilities 7 . Specimen Collection 7 . . a notice that a child in their care has a serious abnormal newborn screen, or has been diagnosed with a newborn . health care professionals as a reference guide to newborn screening in Illinois. This resource provides protocols
P007 Newborn affected by oth medical procedures on mother, NEC P0081 Newborn affected by periodontal disease in mother P0089 Newborn affected by oth maternal conditions P009 Newborn affected by unsp maternal condition P010 Newborn (suspected to be) affected by incompetent cervix P011 Newborn (suspected to be) affected by premature ROMFile Size: 1MB
Data collection and performance analysis report: Newborn blood spot screening in the UK 2016 to 2017 5 decreasing, it still remains the largest contributor of avoidable repeats for most . (1 April to 31 March) unless stated otherwise. The year '2016 to 2017' for example, refers to the financial year 1 April 2016 to 31 March 2017.
age where the parent(s) / guardian wishes to defer blood spot card collection. Exceptions to Recommended Practice: Collection of two blood spot cards may not apply if a health authority / hospital has a standard process in place to follow-up after discharge to ensure a blood spot card is collected, or if the
Newborn examination . As part of this project, you will be conducting a newborn examination. All births (both live and still births) that occur within the study will need to have a newborn exam completed. A newborn examination has many purposes including: It allows us to quickly identify certain problems the baby may have been born with, and
Newborn Care: A Guide to the First Six Weeks Facilitator’s Guide 2013 InJoy Productions, Inc. Permission to copy granted. 2 Introduction (0:59) a. Parenting a newborn may seem mysterious at first, but with time and experience, new parents will learn how to best care for their baby 1. Your Newborn (3:09) a. Newborn Appearances – baby’s .
