APPENDIX G VISTA BLOOD BANK USER MANUAL … BLOOD BANK USER MANUAL SAFETY CRITICAL REQUIREMENTS. ......

August 1998 Laboratory V. 5.2 Appendix G-1Blood Bank User Manual

APPENDIX GVISTA BLOOD BANK USER MANUALSAFETY CRITICAL REQUIREMENTS

Lab V.5.2b Install Guide

Appendix G-2 Laboratory V. 5.2 August 1998Blood Bank User Manual


Table of Contents

VISTA Laboratory Blood Bank Software Version 5.2 -----------------------------------------------------5Safety Critical Requirements --------------------------------------------------------------------------------------5

Introduction--------------------------------------------------------------------------------------------- 5BLOOD PRODUCT file (#66) Data Elements and Descriptions of Use -----------------------------7Donor Safety Critical Requirements--------------------------------------------------------------------------- 11

1. Donor Functions ---------------------------------------------------------------------------------- 11Inventory Safety Critical Requirements --------------------------------------------------------------------- 15

2. Inventory Functions ----------------------------------------------------------------------------- 15Patient Safety Critical Requirements ------------------------------------------------------------------------- 19

3. Patient Functions -------------------------------------------------------------------------------- 19


Table of Contents



VISTA Laboratory Blood Bank Software Version 5.2Safety Critical Requirements

Introduction

As defined by the Food and Drug Administration (FDA), a safety criticalrequirement is one that is implemented to ensure the safety, quality, identity,potency and purity of blood/blood products and/or donor safety. These requirementsare based on a variety of regulatory and accreditation requirements of the FDA, theAmerican Association of Blood Banks (AABB) and the College of AmericanPathologists (CAP). Consistent with the software and the other documentation, thesafety critical requirements detailed in this document have been divided into threemajor categories, (i.e., donor, inventory and patient). These categories relate to thefile structures used for data storage as well as to the logical groupings of functionalactivities in the blood bank.

Information provided in Appendix E of the Blood Bank User’s Manual providesdetails for each of the Blood Bank files. Included are some ancillary files which arenot fully detailed in this document, but have some software control and should beused as an additional reference.

In Appendix F of the Blood Bank User Manual, a listing is provided of the fieldsand subfields for the files used for data storage for each of the major categories. Theformat selected indicates the hierarchical arrangement of the file structure. Inaddition to the field number and field name, a designation has been included toindicate whether changes in verified data for that specific field for that specificdonor/unit/patient are tracked by being entered on the audit trail. Fields that exist,but are not currently in use have been included and have been so designated. Forthose fields which are not accessible for editing or which serve as the referencepoint for the subfields, an ‘NA’ has been used.

A listing of the safety critical requirements is provided on the following pages.These are also referenced in the software requirement specifications in Appendix Hand the hazard analysis in Appendix 1. Appendix H of the Blood Bank User’sManual provides additional details on the software requirements specifications.These will include the design safeguard, e.g. algorithms, truth tables, errorchecking, record locking, etc. to ensure that the safety critical requirements(s) ismet.


Safety Critical Requirements Introduction



BLOOD PRODUCT file (#66) Data Elements andDescriptions of Use

Because the BLOOD PRODUCT file (#66) plays a significant role in the softwaredesign and is referenced frequently in the safety critical requirements, the listing ofthe data elements is provided here as a quick reference.

Field # Field Name Description Of Use.01 NAME Identifies product..02 ABBREVIATION Characteristic used to access/identify this

specific component..03 CAN BE MODIFIED Determines whether this product can be

modified into other products..04 IDENTIFIER Determines whether this file entry can be accessed (only

component/derivatives with IDENTIFIER = BB) should be accessible at any promptwhich references component.

.05 PRODUCT CODE Characteristic used to by bar code reader orby manual entry to access this specificcomponent.

.055 DOD CODE Used by the Department of Defense.

.06 MODIFICATION CRITERIA Determines the edit template used whenthis product is selected during modificationof another product.

.07 PATIENT/PRODUCT ABO Determines whether units selected for apatient must be identical or must be red cellcompatible.

.08 PATIENT/PRODUCT RH Determines whether units selected for apatient must be identical or must be redcell compatible.

.09 PATIENT/PRODUCTREQUIREMENT

Determines whether units must becrossmatched or if the product containslarge volumes of plasma that should becompatible with the patient’s red cells.

1 VOLUME (ml) Characteristic.11 DAYS LEFT Calculates the new expiration date required

if this product is prepared from anotherproduct present in inventory.


BLOOD PRODUCT file (#66) Data Elements and Descriptions of Use


Field # Field Name Description Of Use.12 ANTICOAGULANT/

ADDITIVEPrevents mixing of components duringmodifications (e.g., a product that hasCPDA- I cannot be modified to a productthat has CPD as the anticoagulant).

.13 COLLECTION/PREP HOURS In the donor module options only,(i.e., indicates the maximum time allowablebetween the Date/Time Collection Startedfield (#65.54,4.2) and the Date/Time Storedfield (#65.66, .03).

.135 MAXIMUM STORAGE DAYS In the donor module option, calculates thedefault shown for the Expiration Date field(# .04), in the Inventory Module option,Screens the Entry For the Expiration Date/Time field (#.06) for potential data entryerrors.

.14 MODIFIED BEFORERELEASE

Prevents issue/relocation of products whichmust be modified such as Frozen Red BloodCells which must be deglycerolized beforeissue.

.15 CAN BE REQUESTED Prevents selection of products that shouldnot be accessed/selected.

.16 PATIENT SPECIMEN AGEALLOWED

Prevents selection of units of this productfor specimens. IF the difference betweenthe current time and the BLOOD SAMPLEDATE/TIME exceeds the entry in this fieldfor this product.

.18 RETYPE AFTERPREPARATION

Determines whether units of this productmust be retyped before issue/release.If YES, units which are created using theDisposition-not transfused [LRBLIDN]option will appear on the InventoryABO/Rh testing worksheet generated bythe [LRBLIW] option.

.19 CONTAINS RED BLOODCELLS

(1) Determines whether units of this product retyped before issue/release. If YES, unitswill not be able to be released using theDisposition-relocation [LRBLIDR] optionuntil required recheck results are entered.(2) Used for sorting purposes on somereports.

.21 MAX AGE FOR PEDIATRICUSE

Determines whether units of this productcan be modified into pediatric units.

.22 PEDIATRIC PRODUCT Determines which products can be accessedwhen modifying a unit in inventory usingthe Pediatric unit preparation [LRBLPED]option; (both must also have the sameentry in the BLOOD PRODUCT file (#66),Anticoagulant/Additive field (#12).



Field # Field Name Description Of Use.23 SPECIFIC GRAVITY In the Pediatric unit preparation

[LRBLPED] option, (i.e., used to convert thevolume of the unit in mls. into anequivalent wt. in gms).

.24 MAXIMUM INFUSIONTIME(MIN)

Used to determine which units should beincluded in the Prolonged transfusion timesreport. The report is generated by theProlonged transfusion times [LRBLPIT]option.

.25 AUTOLOGOUS/DIRECTEDCOMPONENT

Determines whether additional data isneeded to restrict selection of the unit forthe intended patient Restricted For field(#8) of the BLOOD INVENTORY file (#65).

.26 ADMINISTRATIVECATEGORY

Used to determine which units should be included inseveral different reports, (e.g., PhenotypedUnits Available [LRBLIPH] and Blood BankAdministrative Data [LRBLA] options).

.27 POOLED PRODUCT Determines whether a unit specificproduct can be accessed through theEdit Pooled Blood Product [LRBLJM] option; usedby the Blood bank inventory integrityreport [LLRBLII] option to determine whichfields may have missing data.

.28 ASK BAG LOT # Determines whether the BLOODINVENTORY file (#65), Bag Lot # field (#1)should be included in the edit template used by theDisposition-not transfused [LRBLIDN]option when modifying units.

1 DESCRIPTION Subfile (#66.09)Description field (#.01)

Intended for use for display purposes infuture.

2 SYNONYM Subfile (#66.021)Synonym field (#.01)

Used for look-up access purposes only.

3 MODIFY TO Subfile (#66.03)Number field (#.001)

Internal file number.

.01 MODIFY TO Determines which products can be accessedwhen modifying a unit in inventory usingthe Disposition-not transfused [LRBLIDN]option.

.02 NOT ONLY ONE ALLOWED Determines whether more than oneproduct may be created when modifying aunit in inventory using the Disposition-nottransfused [LRBLIDN] option.

4 SUPPLIER Subfile (#66.01)Preference number field (#.01)

Controls the display order.

.01 SUPPLIER Name of supplier Determines characteristics based onsubfields detailed below.

.02 COST Calculates expenses for reports.

.03 ADDRESS LINE 1 Used for look-up and information purposesonly.




Field # Field Name Description Of Use.04 ADDRESS LINE 2 Used for look-up and information purposes

only..08 ZIP CODE Used for look-up and information purposes

only..09 PHONE Used for look-up and information purposes

only..01 LOT # Not currently used by the software..02 Expiration Date Not currently used by the software.5 CRITERIA FOR USE Subfile

(#66.05), Criteria For Use field(#.01)

Intended for use for display purposes in thefuture

6 TESTS TO CHECK Subfile(#66.04), Tests To Check field(#.01)

Used to identify/flag non pre-oprequests that exceed the audit criteria(may enter more than one).

.02 SPECIMEN Type of specimen used for test.

.03 > OR < TEST VALUE Value to be used to identify/flag non pre-op component requests that exceed the auditcriteria.

7 REQUISITION INSTRUCTIONSSubfile (#66.07), RequisitionInstructions field (#.01)

Intended for use for display purposes in thefuture.

8 PRE-OP TESTS TO CHECKSubfile (#66.08), Pre-Op Tests ToCheck field (# .01)

Used to identify/flag pre-op componentrequests that exceed the audit criteria(may enter more than one).

.02 SPECIMEN Type of specimenused for test .03 > OR < TESTVALUE

Value to be used to identify/flag pre-opcomponent requests that exceed the auditcriteria.

.01 WKLD CODE Used for workload captures by theDisposition -not transfused [LRBLIDN]option and the Collection disposition/component preparation [LRBLDCP] option.



Donor Safety Critical Requirements

As with the file structure and the documentation, the safety critical requirements are dividedthree major categories, donor (D), inventory (I) and patient (P). Within each of the majorcategories, the term ‘general’ has been used for those SCR which involve more than onefunctionality.

1. Donor Functions

SCR# Functionality DescriptionD1 Donor - General A unique cumulative donor record must exist

for each individual blood donor/patient.D2 Donor - General A system to ensure confidentiality of donor

Records must be established and followed.D3 Donor - General A unique cumulative donation sub-record

must exist for each individual blood donation.D4 Donor - General Data should be accurate and the potential for

data entry errors should be minimized whenever possible.

D5 Donor - General A system must exist to track changes madeto verified data for specified data elements.

D6 Donor - General A system must exist to require a higher levelof security access in order to perform specifiedfunctions, (e.g., removal of unitsfrom quarantine).

D7 Donor - General Each facility must have a record-keepingsystem which makes it possible to trace anyunit of blood/blood component from source tofinal disposition, to recheck the recordsapplying to a specific unit and to investigateadverse reactions manifested by the recipient.

D8 Donor - General Facility records be complete, retrievable in areasonable period of time, preserved andprotected from accidental or unauthorizeddestruction of modification and maintainedfor the required retention period.

D9 Donor - General Autologous units and directed donor unitsshould be made available for a patient beforehomologous blood is selected.

D10 Donor-Registration,Screening, and Collection

Allogeneic (homologous and directed) blooddonors may and Collection not donate wholeblood more often than every 8 weeks.


If blood donors are not at least 17 years of age,they and Collection must have permission todonate. Prospective donors who are consideredminors may be accepted if written consent todonate has been obtained in accord withapplicable law.



SCR# Functionality DescriptionD12 Donor-Registration,

Screening, and CollectionElderly prospective donors may be accepted atthe and Collection discretion of the blood bankphysician.


Donor history questions must meet therequirements of and Collection the FDA andthe AABB.


All permanently deferred donors must beappropriately and Collection identified in orderto prevent the donation or the inappropriaterelease of units to inventory.


All permanent deferral information must betraceable, and Collection including changes instatus..


Donors who require special handling should beand Collection identified so that appropriateprocedures can be implemented.


All units collected in bags of a specific lot mustbe able and Collection to be identified in caseof potential recalls.

D18 Donor-ComponentPreparation

A mechanism must exist to track all collectiondispositions and to track the storage of each/allcomponents prepared.


Components must be prepared within themaximum time allowable for that specificcomponent.


If the dating period for the product is < 72hours, the expiration date must include thehour of expiration.

D21 Donor-Processing/Transfusion transmitteddisease (TDD) markertesting

Current ABO/Rh test results must be inagreement transmitted disease (TDD) with thedonor’s historical record, and if a discrepancymarker testing exists, release of units of blood/blood components to inventory requires ahigher level of security access.


Implementation of the required transfusiontransmitted disease (TTD) transmitted diseasemarker testing must be done as marker testingrequired by the FDA.


A system should exist for detecting missingspecimens transmitted disease (TTD) in orderto minimize the possibility of errors in markertesting transfusion transmitted diseasemarker testing.



SCR# Functionality DescriptionD24 Donor-Processing/

Transfusion transmitteddisease (TDD) markertesting

If results are entered after the unit of blood/blood transmitted disease (TDD) componenthas been released on an emergency basis,marker testing the results must beimmediately evaluated to determine whetherthe quality or the safety of the product isadversely affected.

D25 Donor-Labeling/Release Units cannot be released to inventory, evenunder emergency circumstances, until currentABO/Rh testing has been entered.

D26 Donor-Labeling/Release Under routine circumstances, allogeneicshould only be released to inventory after all ofthe required testing has been completed andmeets current FDA requirements.

D27 Donor-Labeling/Release Sufficient safeguards should be in place in thelabeling/release procedure to prevent labelingerrors.

D28 Donor-Labeling/Release Whenever possible, technology should beutilized to verify the accuracy of labelinginstead of relying on a second person.

D29 Donor-Labeling/Release A unique cumulative unit record must becreated in the Inventory File when units arereleased from the Donor File in order toprevent data entry errors.

D30 Donor-Labeling/Release A mechanism must exist to track the finaldisposition of each and all componentsprepared.


Inventory Safety Critical Requirements

2. Inventory Functions

SCR# Functionality Description11 Inventory General A unique cumulative unit history record

must exist for each individual bloodcomponent.

12 Inventory General A system to ensure confidentiality of patientrecords/transfusion histories must beestablished and followed.

13 Inventory General Data should be accurate and the potential fordata entry errors should be minimizedwhenever possible.

14 Inventory General A system must exist to track changes madeto verified data for specified data elements.

15 Inventory General A system must exist to require a higher levelof security access in order to performspecified functions.

16 Inventory General Each facility must have a record-keepingsystem that makes it possible to trace anyunit of blood/blood component from source tofinal disposition, to recheck the recordsapplying to a specific unit and to investigateadverse reactions manifested by the recipient.

17 Inventory General Facility records be complete, retrievable ina reasonable period of time, preserved andprotected from accidental or unauthorizeddestruction of modification and maintainedfor the required retention period.

18 Inventory General Autologous units and directed donor unitsshould be made available for a patient beforehomologous blood is selected.

19 Inventory General Required A.BO/Rh confirmatory testing mustbe done after the unit has been labeled topermit detection of labeling errors.

110 Inventory Receipt,Shipment, and Discard ofUnits

If the dating period for the product is 72hours, the and Discard of Units expirationdate must include the hour of expiration.

111 Inventory Receipt,Shipment, and Discard ofUnits

If units are shipped outside of the collectingfacility, all and Discard of Units requiredtransfusion transmitted disease markertesting must have been performed and unitsmust be handled in accordance with FDAregulations.



SCR# Functionality Description112 Inventory Receipt,

Shipment, and Discard ofUnits

Facilities need to maintain shipping recordsindicating and Discard of Units thatappropriate temperatures have beenmaintained.

113 Inventory - ConfirmationTesting of units

Test results for confirmatory ABO/Rh mustbe in of units agreement with the unit’shistorical record and the unit may not bereleased for transfusion if a discrepancyexists.

114 Inventory – Modificationof Units

Critical information regarding patientassignments (if Units any), specialphenotypings, CMV antibody status, etc.is maintained when a unit is modified.

115 Inventory – Modificationof Units

If any unit within a pooled product is Rhpositive, the Units pooled product should belabeled as Rh positive.

116 Inventory – Modificationof units

Appropriate procedures must be in place tominimize Units risks to employees who mayhandle biohazardous materials., i.e. unitswith incomplete or positive test results fortransfusion transmitted disease markers.

117 Inventory - Modificationof units

Records must be maintained of the lotnumbers of all Units bags used in themanufacturing process and a specific lotmust be able to be identified in case ofpotential recalls.

118 Inventory - Issue\relocationof units for transfusion

Delays in providing appropriately testedunits for units for transfusion should beminimized.

119 Inventory - Issue/relocationof units for transfusion

Before a unit is released for transfusion,current test units for transfusion resultsshould be complete and compared with thepatient history to detect possible ors inABO/Rh or a previous history of a clinicallysignificant antibody.


Required ABO/Rh confirmatory testing mustbe units for transfusion completed before theunit is released for transfusion.


Units shall not be issued for transfusion ifthe visual units for transfusion inspectionindicates the presence of an abnormal coloror physical appearance.


Units should not be transfused after theexpiration units for transfusion date & timeindicated on the unit.



SCR# Functionality Description123 Inventory - Issue\relocation

of units for transfusionUnits which require further modification,such as units for transfusion frozen red bloodcells, must not be issued until furthermodification has been completed.


A label or tie tag with the requiredinformation must units for transfusion beattached to the unit before it is issued fortransfusion.

125 Inventory - Phenotypingof units

A standardized coding system should beutilized for units identifying both RBC andHLA antigens and antibodies in order tominimize problems associated with free text.

126 Inventory - Release of unitsto stock/available inventory

Autologous units which are collectedpreoperatively stock/available inventorymust be segregated and used solely for thispurpose unless the donor-patient and thedonated unit meet all of the allogeneic donorrequirements.


Patient Safety Critical Requirements

3. Patient Functions

SCR# Functionality DescriptionP1 Patient - General A unique cumulative patient history record

must exist for each patient that includes theABO/Rh, clinically significant antibodies,transfusion reactions and units transfused.

P2 Patient - General A system to ensure confidentiality of patientrecords/transfusion histories must beestablished and followed.

P3 Patient - General Data should be accurate and the potentialfor data entry errors should be minimizedwhenever possible.

P4 Patient - General A system must exist to track changes madeto verified data for specified data elements.

P5 Patient - General When changes are made in data which hasbeen previously transmitted outside of thelaboratory, there must be a means to clearlyidentify the original and the corrected data.

P6 Patient - General A system must exist to require a higher levelof security access in order to performspecified functions, (e.g., approval of thestatus change to ‘assigned’ for units withincompatible crossmatches which may betransfused with the Blood Bank MedicalDirector’s approval.

P7 Patient - General A standardized coding system should beutilized for identifying RBC antigens andantibodies in order to minimize problemsassociated with free text.

P8 Patient - General Supervisors should review test results andexception reports.

P9 Patient - General Each facility must have a record-keepingsystem which makes it possible to trace anytransfusion from receipt of the unit to finaldisposition, including, but not limited to,confirmatory testing, pretransfusion testing(if applicable) and issue/relocation.

P10 Patient - General Facility records, including patient ABO/Rhresults for the past 12 months and anyprevious history of clinically significantantibodies must be retrievable in areasonable period of time, preserved andprotected from accidental or unauthorizeddestruction or modification and maintainedfor the required retention period.



SCR# Functionality DescriptionP11 Patient - General In order to provide appropriate clinical

information to the patient’s MD, thepatient’s physician should be notified ofabnormal test results.

P12 Patient - Old records Patients with a previous history of a clinicallysignificant antibody or a transfusion reactionshould be identified so that appropriate bloodcomponents can be selected.

P13 Patient - Specimen receiptand order entry

Requests for blood components must containsufficient order entry on for positiveidentification of the recipient, i.e. at least thefirst and last names and an identificationnumber.


Before a unit is released for transfusion,current test order entry results must becompared with the patient history to detectpossible errors in ABO/Rh or a previoushistory of a clinically significant antibody.


Before a specimen is used for pretransfusiontesting, a order entry qualified person in thetransfusion service must be confirm theidentification information on the requestform and the specimen label which includesat least the recipient’s first and last names,identification number and the date of thesample collection.


If the patient has been transfused in thepreceding three order entry months with ablood component containing red blood cellsor if the history is uncertain or unavailable,the specimen used for pretransfusion testingmust be obtained from the patient withinthree days of the scheduled transfusion.


Because of the risks inherent to bloodtransfusion, order entry there needs to be anactive blood usage review process.


Autologous and directed units should bemade order entry available for patient beforeallogeneic (homologous) blood is selected.


Access to components which require furtherprocessing order entry should be limited.

P20 Patient - Test result entry(other than crossmatching)

Each blood sample must be tested forABO/Rh and for (other than crossmatching)unexpected antibodies as part of the pre-transfusion testing.

P21 Patient - Unit selection andpretransfusion testing

Access to units which are expired should belimited pretransfusion testing.


Required ABO/Rh confirmatory testing mustbe done to pretransfusion testing permitdetection of labeling errors.



SCR# Functionality DescriptionP23 Patient - Unit selection and

pretransfusion testingRecipients shall receive ABO specific wholeblood or pretransfusion testing ABOcompatible red blood cell components.


Rh negative recipients should receive Rhnegative red pretransfusion testing bloodcells.


Criteria for selection of units for transfusionmust be pretransfusion testing defined andshould be component specific and deviationsmust be approved and documented per thefacility’s SOP.


Criteria for required testing must be definedand pretransfusion testing should becomponent specific.


The rationale for the release of units whichare not pretransfusion testing ABO/Rhcompatible must be provided by therequesting physician and must bedocumented.


Required compatibility testing must beperformed and pretransfusion testing resultsacceptable before the unit is made availablefor issue for subsequent transfusion.


Before a unit is released for transfusion,current test pretransfusion testing resultsshould be compared with the patient historyto detect possible errors in ABO/Rh or aprevious history of a clinically significantantibody.


A label or tie tag with the recipients firstand last pretransfusion testing names andidentification number, the donor unit numberand the interpretation of the compatibilitytests, if performed, must be attached to theunit before it is issued for transfusion.


If clinically significant antibodies aredemonstrated or pretransfusion testing ifthere is a history of such, units should lackthe corresponding red cell antigen.

P32 Patient - Investigation ofadverse effects

A mechanism must exist to record andevaluate all diverse effects cases of suspected transfusiontransmitted disease.

P33 Patient - Investigation ofadverse effects

Each facility shall have a system fordocumenting adverse effects transfusioncomplications in the patient's record.

APPENDIX G VISTA BLOOD BANK USER MANUAL … BLOOD BANK USER MANUAL SAFETY CRITICAL REQUIREMENTS. ......

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