APPENDIX H VISTA BLOOD BANK USER MANUAL SOFTWARE .

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APPENDIX HVISTA BLOOD BANK USER MANUALSOFTWARE REQUIREMENTSSPECIFICATIONSAugust 1998Laboratory V. 5.2Blood Bank User ManualAppendix H-1

Appendix H-2Laboratory V. 5.2Blood Bank User ManualAugust 1998

Table of ContentsVISTA Blood Bank Software Version 5.2 Software Requirements Specifications . 5Introduction . 5Software Requirements Specifications General . 6Donor Software Requirements Specifications . 7Inventory Software Requirements Specifications . 19BLOOD INVENTORY file (#65) Data Integrity Check . 27Patient Software Requirements Specifications . 31August 1998Laboratory V. 5.2Blood Bank User ManualAppendix H-3

Table of ContentsAppendix H-4Laboratory V. 5.2Blood Bank User ManualAugust 1998

VISTA Blood Bank Software Version 5.2 SoftwareRequirements SpecificationsIntroductionThe Software Requirement Specifications (SRS) provide detailed informationregarding the functionality of the software. These requirements are based on theintended uses detailed in Appendix F and the Safety Critical Requirements detailedin Appendix G. A variety of tools are available for use in meeting thesespecifications. In general, the data dictionary for specific files provides a great dealof control through the data type, pattern matches, and input transformrequirements. However, specific algorithms have been included in the softwareroutines where appropriate and Kernel Security and Menu Management providesadditional tools (i.e., menu access and security keys for meeting the specifications).As with the file structure and the rest of the documentation, the SoftwareRequirement Specifications are divided into one general (G) and three majorcategories, donor (D), inventory (I) and patient (P). The numbering system usedindicates which category is assigned to that particular specification (e.g., SRS#G1)is the first in the general category.In order to assist in cross-referencing material and minimizing duplicationwhenever possible, the information in the column labeled “Functionality” roughlycorresponds to the Safety Critical Requirements in Appendix G and the options.However, the term “general” has been used for those SRS which apply to more thanone functionality. In addition, the Safety Critical Requirements do not include thoseSRS that relate only to the generation of administrative and management reports.August 1998Laboratory V. 5.2Blood Bank User ManualAppendix H-5

Software Requirement SpecificationsSoftware Requirements Specifications neralAppendix H-6DescriptionRequires both an access code and a totally encrypted verifycode that must be changed every 90 days in order to accesscomputer system.Requires assignment of specific menu options and specificsecurity keys in order to access/enter donor data.Utilizes an automatic time-out algorithm and site specifiedtime-out parameters to prevent potentially inappropriateaccess, in the event that an authorized user were to breach theusual security measures and leaves the CRT unattended whilestill signed on.Provides on-line documentation and help prompts based on thedata dictionaries for the files used by the donor menuoptions/routines.Provides detailed data dictionaries for each file which provideall of the specific details, including name and number of thefield, the global location, the type of data, etc. Additionaldetails are provided in Appendix F that includes a detaileddescription of the data elements for the various files as part ofthe Intended Uses.Requires assignment of specific menu options and specificsecurity keys in order to access/enter inventory/patient data.For sites which are defined as multidivisional in theINSTITUTION file (#4), requires assignment of user access bydivision in order to access/enter data for a specific division.For sites which are defined as multidivisional in theINSTITUTION file (#4), assigns the division of the user basedon data entered during the sign-on process and uses thisdivision for determining access as detailed in other specificSRS.For sites which are defined as multidivisional in theINSTITUTION file (#4), allows user to change divisions duringa ‘session’, providing the user has the appropriate accessUtilizes a variety of VA FileMan features and tools to routinelyprovide a 2-second average response time between prompts.Provides an interface with a bar code reader as a peripheraldevice, connected in-line between the CRT and CPU via cables,which is able to read Stop Codes and Codabar symbology inaccordance with the Uniform Blood Labeling Act.Provides ability for the user facilities to document the softwarevalidation performed by the site.Provides audit trail report of the changes in verified data.Note: This report requires a higher level of security to access.Restricts data entry based on the data type and the inputtransforms for the specific field.Laboratory V. 5.2Blood Bank User ManualAugust 1998

Donor Software Requirements SpecificationsSRS#FunctionalityD1Donor - GeneralD2Donor - GeneralD3Donor - GeneralD4Donor - GeneralD5Donor - GeneralD6Donor - GeneralD7Donor - GeneralD8Donor - GeneralD9Donor- GeneralD10Donor - GeneralD11Donor - GeneralD12Donor - GeneralAugust 1998DescriptionRequires assignment of specific donor menu optionsand specific security keys in order to access/enter donordata.Provides data dictionary for the files used by the donormenu options/routines. See Appendix G for a listing ofthe data elements in the BLOOD DONOR file (#65)and the BLOOD PRODUCT file (#66).Provides the ability to set up a site parameter. A siteparameter would indicate whether the ABO/Rh resultsshould be moved to the BLOOD INVENTORY file (#65)when the unit is labeled/released because the ABO/RHrecheck is performed prior to release. (LABORATORYSITE file (#69.9)), FIRST DEFAULT for DONOR).Provides the ability set up a site parameter to indicatewhether the bag lot # should be included in the edittemplate for entering collection data. (LABORATORYSITE file (#69.9), THIRD DEFAULT for DONOR).Provides the ability to set up a site parameter toindicate whether the Donor SSN should be included inthe edit template for registering a donor.(LABORATORY SITE file (#69.9), FOURTHDEFAULT for DONOR).Provides the ability to set up a site parameter. A siteparameter is to indicate whether ALT testing should beincluded in the edit template for entering TTD markerresults and for evaluation of results duringlabeling/release. (LABORATORY SITE file (#69.9),FIFTH DEFAULT for DONOR).Provides the ability to set up a site parameter. A siteparameter is to indicate whether the HIV Antigentesting should be included in the edit template forentering TTD marker results and for evaluation of theresults during labeling/release. (LABORATORY SITEfile (#69.9), SIXTH DEFAULT for DONOR).Includes set of codes as choices of potential outcomes ofeach donation attempt (i.e., whole bloodplasmapheresis, cytapheresis, and no donation).Specifies donation type for each donation, (i.e.,homologous, autologous, therapeutic, or directed).Creates a unique cumulative donor record for eachindividual blood donor/patient that includes a varietyof identification and demographic information.Creates a unique cumulative donation sub-record foreach individual donation/deferral date.Updates record immediately upon data entry.Laboratory V. 5.2Blood Bank User ManualAppendix H-7

Donor Software Requirements SpecificationsSRS#FunctionalityD13Donor - GeneralD14Donor - GeneralD15Donor - GeneralD16Donor - GeneralD17Donor-Old RecordsD18Donor-Old RecordsD19Donor-Old RecordsD20Donor-Registration, Screeningand CollectionD21Donor-Registration, Screeningand CollectionD22Donor-Registration, Screeningand CollectionD23Donor-Registration, Screeningand CollectionD24Donor-Registration, Screeningand CollectionD25Donor-Registration, Screeningand CollectionD26Donor-Registration, Screeningand CollectionAppendix H-8DescriptionLocks donor record during data entry to prevent accessby another terminal/user for specified options.Tracks the person performing various steps in theprocess (i.e., person entering data into the computer).Accommodates the use of a bar code reader for entry ofthe unit ID.Tracks changes in verified data for specific dataelements defined in the BLOOD DONOR file (#65.5).See Section IX for listing by data element.Accommodates entry of historical donor information ifdeemed appropriate and identifies the specific donationdates for which data was entered via that option.During data entry of each unit ID, checks the unit IDsalready in existence in the BLOOD INVENTORY file(#65) to identify potential duplicates/inappropriateentries.Once the donor record has been created, preventsaccess to donor through the ‘Old records’ option.During the registration of each blood donor, checksexisting entries in the BLOOD DONOR file (#65.5) forduplicate donors, based on comparison of the nameand/or a combination of the first letter of the last name,sex, and date of birth.Prevents assignment of “duplicate” unit IDs based on asearch of existing entries in the BLOOD DONOR file(#65.5).Calculates age of donor based on his/her date of birth,then checks age of donor to see if outside limits anduses algorithm to display warning message if donor is 17 or 65 years of age.If the DONATION TYPE HOMOLOGOUS, checksthe previous donation date to determine if at least 8weeks has elapsed between the last donation date andthe current donation date being entered. Requiresadditional security access and different option to enterdata if collection has already been completed andtracks entry of data for inclusion on audit trail.Allows editing of donor history questions at thediscretion of the facility in order to meet changes inregulatory and accrediting agency requirements.(Requires higher security level).Allows editing of the donor consent at the discretion ofthe facility in order to meet changes in regulatory andaccrediting agency requirements. (Requires highersecurity level).Provides a report of permanently deferred donors foruse at remote sites where the computer system is notaccessible and preprinted donor history forms may notbe available for all potential donors.Laboratory V. 5.2Blood Bank User ManualAugust 1998

Donor Software Requirements on, Screeningand CollectionD28Donor-Registration, Screeningand CollectionD29Donor-Registration, Screeningand CollectionD30Donor-Registration, Screeningand CollectionDonor-Registration, Screeningand CollectionD31D32Donor-Registration, Screeningand CollectionD33Donor-Registration, Screeningand CollectionD34Donor-Registration, Screeningand CollectionD35Donor-Registration, Screeningand CollectionD36Donor-Registration, Screeningand CollectionDonor-Registration, Screeningand CollectionDonor-Registration, Screeningand CollectionD37D38August 1998DescriptionPrevents entry of collection data if allogeneic(homologous) donor is permanently deferred. Requiresadditional security access and a different option toenter data if collection has already been completed,and tracks entry of data for inclusion on audit trail.If an autologous donor or therapeutic phlebotomypatient is permanently deferred is selected for dataentry, displays warning message.IF donor is permanently deferred, includes aninformational warning message at the bottom of theheader on the page used to record the results of thephysical exam, (i.e., either page 2 or 3 ) depending onthe number of questions.Allows entry of free text special comments in the DonorComments field (#9) for future referencePrints donor specific Donor History (DH) forms uponcommand (i.e., DH forms contains the donordemographics, date of last donation, site specific donor,history questions, site specific donor consent, and apage to use for recording data from the modifiedphysical exam). User can opt to print forms for onlythose donors in the print queue who can add donors tothe queue, either individually or based on a specificgroup affiliation. User can also specify the collectionsite and donation date so the forms can be used eitherfor the date on which they are printed or can be printedin advance for an upcoming drive.Based on the entry in the Donor Comments field (#9), a‘Special Comments’ section is included on the DonorHistory form. The Special Comments section is used torecord the results of the physical exam, depending onthe number of donor history questions. The DH form‘Special Comments’ section is located at the bottom ofthe header of the page (i.e., page 2 or 3).Provides field for indicating whether the donor had adonor reaction, making information available througha variety of report and inquiry options.Provides link between autologous donor/patient andlimits entry of patient restrictions for autologous unitsto patients in the PATIENT file (#2).For autologous units, compares birthdate of donor tobirthdate of the patient being selected for the entry inthe BLOOD DONOR file (#65.5), Restricted For field(#5,1.2).Provides field for the input of the bag lot # which canthen be detailed in future FileMan search requests.Prevents access for entry of collection information ondonors entered through ‘Old records’.Prevents entry of future donation date/time.Laboratory V. 5.2Blood Bank User ManualAppendix H-9

Donor Software Requirements ation, Screeningand CollectionDonor-Registration, Screeningand CollectionD41Donor-Component PreparationD42Donor-Component PreparationD43Donor-Component PreparationD44D45Donor-Component PreparationDonor-Component PreparationD46Donor-Component PreparationD47Donor-Component PreparationD48Donor-Component PreparationD49Donor-Processing/TTD MarkerTestingD50Donor-Processing/TTD MarkerTestingAppendix H-10DescriptionPrevents entry of a collection completion date/timeprior to the collection start date/time.Calculates collection volume based on the gross weight,the empty bag weight and the specific gravity of wholeblood.Limits access to the donor’s most recent donation, i.e.,user cannot specify a unit ID that is from other thanthe most recent donation.Tracks the date/time stored for each specific componentof a specific unit ID.Evaluates the elapsed time between the collection timeand the date/time stored for the specific component andprevents entry of data for a component for which themaximum allowable component preparation time hasbeen exceeded based on the entry in the BLOODPRODUCT file (#66), Collection/Prep field (#13).Expiration date field accommodates the entry of time.Evaluates the number of components being preparedagainst the bag type and prevents entry of more thanthe maximum that could be logically allowed (i.e., threecomponents cannot be prepared from a double bag).Ensures that no more than 1 RBC component isprepared by excluding selection of other components inthe BLOOD PRODUCT file (#66) that has a ‘YES’ inthe Contains Red Cells field (#19).Excludes selection of components based on acomparison of the anticoagulant entered for thecollection for the specific component based on the entryin the BLOOD PRODUCT file (#66), Anticoagulant/Additive field (#12).Calculates the date portion of the expiration date basedon the donation date and entry in the BLOODPRODUCT file (#66), Maximum Storage Days field(#.135) for the specific component. If the entry in theMaximum Storage Days field (#.135) is a wholenumber, the calculation will be in the format of a dateonly. Whereas, if the entry is a decimal, the calculationwill be in the format of a date and time.Expedites data entry for donor IDs by incrementing theunit IDs and displaying that number as the default IFthe next logical unit ID exists.Checks current ABO/Rh results for the specific donorunit against the donor’s historical record.Laboratory V. 5.2Blood Bank User ManualAugust 1998

Donor Software Requirements /TTD MarkerTestingD52Donor-Processing/TTD MarkerTestingD53Donor-Processing/TTD MarkerTestingD54Donor-Processing/TTD MarkerTestingD56Donor-Processing/TTD MarkerTestingD57Donor-Processing/TTD MarkerTestingD58Donor-Processing/TTD MarkerTestingD59Donor-Processing/TTD MarkerTestingAugust 1998DescriptionIf ABO/Rh unit rechecks are performed prior to therelease of the unit to inventory, rather than after theunit is released to inventory and data is entered,compares recheck information to original processingresult interpretations. However, the original ABO/Rhare NOT displayed at the time of data entry.Prevents the same tech from entering both originaland recheck results for ABO/Rh based on a comparisonof the user identification and the entry in the TechEntering-ABO Interp field (#10.2) for the originalresults.For the tests which have been recentlyimplemented/discontinued (i.e., ALT and HIV Ag)checks the entries in the LABORATORY SITE file(#69.9) to determine whether testing is required andspecifically which of these fields should be accessibleduring data entry.For each unit ID, requires entry of test resultinterpretations for subsequent evaluation duringlabeling/release (no batch entry).Allows generation of worklists for any of the tests.These lists include any incomplete testing, i.e., unitIDs for which there are no test results or which wereadded back to the worklist pending completion ofrepeat and/or confirmatory testing.If results of the transfusion transmitted diseasemarker testing are entered as anything other than“negative” or “non-reactive” for units which havealready been released to inventory on an emergencybasis, a bulletin is automatically generated detailingthe test result is sent to all holders of a specificsecurity key, regardless of the donation type.Prevents editing of results after components arereleased unless the user has a higher level of securityaccess.Provides reports of donor testing results to allow datareview before the actual labeling of the donor units ifso desired. Based on the number of transfusiontransmitted disease markers evaluated, the reportcomes in two parts, each including donation/deferraldate, donor unit ID, donor internal file number,permanent deferral status, ABO/Rh, test results,collection disposition, component, componentexpiration date, labeling tech and verifying tech.Laboratory V. 5.2Blood Bank User ManualAppendix H-11

Donor Software Requirements SpecificationsSRS#FunctionalityD60Donor PhenotypingD61Donor ing/ReleaseD70Donor-Labeling/ReleaseAppendix H-12DescriptionUtilizes a standardized coding system (i.e., SNOMED)for identifying both RBC and HLA antigens andantibodies.Prevents entry of same antigen as ‘present’ and‘absent’.Prevents release of “duplicate” unit IDs to inventorybased on a search of existing entries in the BLOODINVENTORY file (#65).Checks current ABO/Rh results for the specific donorunit and prevents release of units to inventory if nocurrent ABO/Rh results exist.Based on the entry in the LABORATORY SITE file(#69.9) for the DONOR OPTION FIRST DEFAULTfield (#.02) (i.e., yes or no) determines whetherABO/RH recheck data entered prior to release of theunit to inventory is transferred to the BLOODINVENTORY file (#65) when the unit is released.Checks current ABO/Rh results for the specific donorunit against the donor’s historical record and ifABO/RH recheck data is to be transferred to theBLOOD INVENTORY file (#65) when the unit isreleased, prevents release if a discrepancy exists.Checks current ABO/Rh results for the specific donorunit against the donor's historical record, if ABO/RHrecheck data is NOT to be transferred to the BLOODINVENTORY file (#65) when the unit is released,allows release of unit after displaying warningmessage, requiring a higher level of security access torelease the unit and generating a bulletin if unit issubsequently released with ABO/Rh discrepancy.Provides detailed reports of donor’s historical ABO/RH,permanent deferral (if appropriate), test results andcomponent information for review prior to labelingand/or for hard copy documentation.Prevents release of homologous, directed donor andtherapeutic phlebotomy units with positive diseasemarker testing results.Displays required transfusion transmitted testing forreview based on site defined criteria in theLABORATORY SITE file (#69.9) for recent changes inTTD markers required, (i.e., ALT and HIV Antigen)FIFTH DEFAULT and SIXTH DEFAULT for BLOODDONOR, respectively.Evaluates test result interpretations and automaticallychanges the status of allogeneic, directed donor, andtherapeutic phlebotomy units to quarantine if anattempt is made to label/release a unit for which theresults indicate that the unit is not suitable for releaseto inventory, (i.e. positive or reactive).Laboratory V. 5.2Blood Bank User ManualAugust 1998

Donor Software Requirements eleaseD78Donor-Labeling/ReleaseAugust 1998DescriptionRequires a higher level of security access (LRBLSUPER key) to make changes in status from‘quarantine’.Verifies accuracy of labeling of ABO/Rh via bar codereader by comparing the scanned ABO/RH label to theABO/RH results for that unit ID.Prevents the same tech doing both labeling andverifying if labeling/release is done manually based ona comparison of the identity of the user attempting torelease the unit with the entry in the Tech Labelingfield (#.06) for that specific unit.For each component which is labeled/released, assignsa final disposition of RELEASE to each component inthe BLOOD DONOR file (#65.5) and automaticallycreates a new entry in the BLOOD INVENTORY file(#65) with specific associated data elements.Assigns the division of the user who is labeling/releasing the unit into inventory to the unit when theunit is assigned a final disposition in the BLOODDONOR file (#65.5) and unit is entered into theBLOOD INVENTORY file (#65).Puts an entry of ‘YES’ in the Pos/Incomp. ScreeningTests field (#8) for both allogeneic (homologous) andautologous units which are released to inventory withincomplete transfusion transmitted disease markertesting such that those units are identified ifsubsequent attempts are made to modify the unit intoanother blood component or to ship the unit to anotherfacility.Puts an entry of ‘YES’ in the Pos/Incomp. ScreeningTests field (#8) for autologous units released toinventory with positive/incomplete testing such thatthose units cannot be released for use by other patientsand cannot be modified into other non-autologouscomponents.Based on entry in the LABORATORY SITEPARAMETERS file (#69.9) for the FIRST DEFAULTfor the BLOOD DONOR, determines whether ABO/Rhconfirmatory testing results are to be transferred to theBLOOD INVENTORY file (#65). If NO, data is nottransferred and unit contains red cells (based on theentry in the BLOOD PRODUCT file (#66) for thatcomponent), adds the unit to the queue for inclusion onthe Inventory ABO/Rh worklist. If YES, data istransferred and the unit in not added to the queue forinclusion on the Inventory ABO/Rh worklist even if theunit contains red cells.Laboratory V. 5.2Blood Bank User ManualAppendix H-13

Donor Software Requirements D88Donor-RecruitmentAppendix H-14DescriptionFor autologous and directed components, displays thename of the patient that the unit is ‘RESTRICTEDFOR’ in an attempt to make sure that the unit issegregated appropriately.Provides on-line storage of a unique cumulative donorhistory for look back purposes.Provides ability to print a hard copy of the cumulativedonor history before removal of the donors from thecomputer system for those donors who have notdonated since a specified date.Requires use of the Print ex-donors [LRBLDEX] optionto identify and purge ex-donors, (i.e., those who havenot donated since the date specified). Note: Higherlevel of security also required.Provides mechanism for merging data (i.e., donationsub-records) from two donor records in the event that aduplicate donor record was created in error.Provides report of all donors who indicated a specificgroup affiliation to provide feedback to donor groupchairpersons. Users can specify search criteria for thegroup affiliation and the range of donation/deferraldates to be included. Reports are sorted by groupaffiliation and include donor name, ABO/Rh,donation/deferral date, donation/deferral code, donorreaction code and deferral reason.Allows entry of data regarding donation group andcollection site such that activity reports can begenerated to provide feedback to donor groupchairpersons. Users can specify search criteria basedon the specific report selected. Reports include donorgroup affiliation, donation group and or collection sitein addition to donor name, ABO/Rh, donation/deferraldate, donation/deferral code, donor reaction code anddeferral reason.Provides mechanism for entry of standardized lettersthat can be generated, based on their group affiliationinformation, and used for specific targeted donorrecruitment efforts.Provides mechanism for entry of standardized lettersthat can be generated based on a search of all donorswho lack a specific RBC antigen, and used for specifictargeted donor recruitment efforts.Provides mechanism for entry of standardized letters,which can be generated, based on a search of all donorswho have not donated since a specified date to be usedfor specific targeted donor recruitment efforts.Laboratory V. 5.2Blood Bank User ManualAugust 1998

Donor Software Requirements RecruitmentAugust 1998DescriptionGenerates post visit thank you letters for donors whoattempted to donate based on the list of donors createdwhen the donation/deferral data was entered throughthe Donor registration [LRBLDLG] option. Selectingthe appropriate letter text based is on the donation/deferral code.Generates letters for various groupings of donors basedon specified criteria and type of letter selected,inserting the donor name and address for theaddressee for those donors identified in the searchcriteria.Generates labels for various groupings of donors basedon specified criteria, printing the donor name andaddress on the label for those donors identified in thesearch criteria.Generates a list of donors who have not donated since aspecified date, including their name, date of lastdonation, group affiliation, home phone and workphone.Provides report of all donors who have indicated theirwillingness to be called on an emergency basis,including their name, ABO/Rh, home phone, workphone, last donation date and donation/deferral codefrom the last donation date. Note: Users can specifyABO/Rh and date range for donations to be included onreport.Provides report of all donors who have indicated theirwillingness to be called on a regular basis for specifiedmonths and/or holidays, including their name,ABO/Rh, home phone, work phone, last donation date,and donation/deferral code from the last donation date.Provides a report of all donors who have indicated theirwillingness to be called, to be apheresis donors, or forwhich no data was entered regarded their apheresisinterest, sorted by ABO/Rh, including their name,ABO/Rh, home phone, work phone, last donation date,and donation/deferral code from the last donation date.Calculates cumulative donation totals based on userspecific formula and previously entered donation dataand provides reports to be used for donor awards.Provides a mechanism to enter the fact that a donorwas given a gallon donor award and provides a reportlisting all donors who have received gallon donorawards.Laboratory V. 5.2Blood Bank User ManualAppendix H-15

Donor Software Requirements tD104Donor-ManagementAppendix H-16DescriptionProvides report of all first time donors for a specifiedperiod based on the entry in the date registered/editedfield, including collection site, donation group, donorname, work phone, donation/deferral date,donation/deferral type and the deferral reason.Provides report of patient credits in order to providefeedback as the effectiveness of any recruitment effortsdirected at the friends/relatives of patients, includingthe patient name, the donor name and thedonation/deferral date.Provides a report of short draw collections, (i.e., forcollection volume that is less than 405 ml), for aspecified date range for supervisory review. The reportis sorted by donation date, including unit ID, collectionvolume, donor reaction code, phlebotomist,donation/deferral date, and collection site.Provides report on donor temporary deferrals for adesignated period, sorted by collection site anddonation date. This report may be used for supervisoryreview in order to identify trends or problems withdonor deferrals, including t

and specific security keys in order to access/enter donor data. D2 Donor - General Provides data dictionary for the files used by the donor menu options/routines. See Appendix G for a listing of the data elements in the BLOOD DONOR file (#65) and the BLOOD PRODUCT file (#66). D3 Donor - General Provides the ability to set up a site parameter.

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