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TISSUEBANKING:Continuous.ProcessImprovementforIncreasedPatientSafety

SusanC.Sharpe,MS,MT(ASCP)SBBTransfusionServiceand TISSUeBankSupervisor

Northside Hospital,Atlanta, GA

BarbaraAdams,MSHIOwens& Minor Soluijons

Introduction

.Regulations.Initial State.IntermediateProcess.CurrentProcess

.FutureImprovements

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Regulations

-JCAHO

-FDA

-MBB

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Regulations- JCAHO

.effective July 1, 2005

.Organization has procedures in place andresponSibility for directing the tissue program toindude:- Acquisition-Receipt- Storage- Issuance- Tn!:;"":!

Regulations - JCAHOcont.Allincoming tissue must be logged.Organization's record keeping allows fortraceability of tissues from the source facilitytorecipient or final disposition- Records should document tissue's unique

identifier, source fadlity, expiration date,recipient or final disposition.System for completion and return of tissue

usage information cards to source fadlities(tissue banks, bone banks, etc.)

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Regulations - FDA

. FDAregulations effective May 25, 2005

- Subpart A & B-Registration Rule

- Subpart C- Donor Bigibility

- Subpart D, E , & F - cGTP rule

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Regulations - MBB

. SID 5.0 Process Control - Shall havepolicies and validated processes andprocedures that ensure quality of tissue.

. SID 4.3 - Incoming Receipt, Inspection,and Testing - Incoming tissue shall bereceived, inspected, and tested, beforeacceptance or use

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Regulations - MBBcont

. STD 5.11.1 - Transfusion Requests - Requestfor tissue shall contain suffident infonnation tDuniquely identify the patient, including twoindependent identifiers

.STD 7.4.5 - Adverse Events Related to Tissue-Process for investigating adverse events, diseasetransmission, or other suspected adverse eventsrelated tD use of tissue and for promptlyreporting cases tD the source fadlity

Initial State

. Background Information

- State Inspection

- Why Northside decided to move tissuefrom OR to Transfusion Service

3

Initial State - cant

. No true tracking system

. Tissues received in Materials Managementand delivered to OR

. Tissues stored in 3 different physicallocations and sub locations

Initial State - cant

. Problems encountered

- No true tracking mechanism

- Inventory control problems

- Inaeased number of expired tissues

- Recalls difficult to follow-up

Initial State cant

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Intermediate Process

. Tissue Group formed

- Charged with organizing and implementing

tracking system

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Intermediate Process cont

. Tissue Group Members

. OR dinical managers and coordinators

. Transfusion Service SUpervisor

. Lab Direcb:Jr

. Lab Operations Manager

. Mab!rials Management

. Surgical Services Buyers

. Histology (added in August 200S)

Intermediate Process cont, . --..--

......==

......

-1

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Intermediate Process cont---

Intermediate Process cont

. TransfusionServicebegan trackingtissueusing Misys 5.3

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- Supplier codes built

- Tissue codes built (required US assistance)

Intermediate Process cont

. Computer entry

-BPE

- BBR- print BloodProducts received list- SO - to appropriate ORarea

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Intermediate Process cont

. TISSuedelivery to OR areas

-Advantages

.Accountabilityof receipt by OR.Accessibilityby ORto tissue

Intermediate Process cont.TissueDeliveryto ORareas

- Disadvantages

.Transfusion Service staff required to leave department.No a>ntrol of tissue after leaving Transfusion Service-includes storage temperature and monitoring-physical location-rebievalfor recan

- inab~ity to locate all tissues for audit

Intermediate Process .cont

.Tissue Bank Record of Tissue Implantationmanually completed

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Iritermediafel'rocess cont--~------w.

-.-.-_.- ------ -- -- ------- ,,-;(;!;;~:::- =-=. ---:l~p;,l ==--1--.

,;;;;;;:-- --== :: ::-= I'- - I--==--_u !r~

Intermediate cont

. Problems Encountered

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- Transaiption errors on Tissue Bank Record

Intermediate Process

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Current Process Cont

. Alltissue moved to Transfusion Service- Exception - Hemashield Emergency kit

- Required physical renovation of department

Current Process cont

. l1ssue carts In Transfusion Service

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n __n - n --- --_w- __n_n_---

Current Process cont

.Advantages tDcentralized stDrage

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- Continuous bMlpemure and alarm monitxlrlng

- TISSUeaudits (complete inventory)- Controlled access (physical barriers)

- Inventory control- Cost containment

- Less explfiltlon due to rotation of stock

- Recalls - easy access to tissue for follow-up

Current process cont

. Development of Tissue Request forms

-Roomtemperature

- Refrigerated & Frozen

rocess cont,......-...."'"

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;_. ~".- _. I~ ---T_"

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Current Process cant

. Implementation of CYRUStissue trackingsystem

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CYRUS Tissue TrackingSystem

Objectivesof an AutomatedTissueTrackingSystem

. Satisfy JCAHOand FDAregulations

. Increase patient safety

. Reduce inventory losses

. Reduce labor spent tracking implants

. Facilitate efficient utilizationof implants

. Provide extensive reporting on implants

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Logging Incoming Tissue

'-~''''''''''",""",l'''''-'

--J=.- .~~~~=~#:-~~~J~- ~~'- <>-o--~ r-uo-

~-Gr.7.0--~ ,- ~ " --.--- g:-",...- =! ::.':'"..::.i "--..-.-.: 0--- 0-.----

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---.--..-.--.-.--.-----.-------

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BarcodeLabels

2323321805

IInmDmIHllDDllll1LollD 2333333

Sf. ELMOS

TiSSUE SUPPLY

CANCELLOUS SPACER 6 MMReceNed 01~1A:J6 Exptre<1213008 Reorder: 29XOOO

RecordingTissue's Final Disposition

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I¥~:~,- ""1- €- "'''-'-. -; =- !'- -- i: - ~:~~= ~.:::---::":--:::"::-~~ . '- .-- II-~~ G:J!EJ ~ G:J!EJ i- ,... I - :- ,,

eid G:J !EJ I5iJ G:J!EJ !,CB:30;:;0G!W~

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ectronic Tissue Usage Information Card=- ---'- --..-

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Implant Log Report (JCAHOReport):=-, ...-----.--------.--.---....------------

-....:;;;;;;;;;;;;;;""',

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Digital Dashboard ofYourTissue-.--.--.--..-

13

Expiration Report=.

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Current processcont

. FDAvisit

- Within oneweekof goinglive on CYRUS- Physicallocationsof tissuesrequestedby

investigator- Wantedto seethat we hadprocesscontrol

Future Improvements

. Networkingof CYRUS with NorthsicleForsythand NorthsideCherokee

- Advantages.Access to additional users (OR. Purchasing, etc.).Ability to view inventory at sister fadlitles.Abiiity to track all implants in addition to tissue

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Future Improvements cont

. Ordering of Tissue by Transfusion Service

-Advantages

.Maintain minimum par levels (cost containment).Process conbol over complete process (one stop

shopping)

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Future Improvements cont

. Continue to work with OR to fine tune ourprocess

Conclusion

i'. "'~~~

~~f~J:L

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- --- -- -- -- -- -- ----

Acknowledgements

. Thank you to each member of the TISSueGroup, the Transfusion Service, and theOR staff of Northslde Hospital.

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. A special thank you goes to BarbaraAdams for the development of CYRUSandthe years of work she spent developingthis tremendous resource.

Contact Information

. Barbara Adams

- barbaraadams@cyrusmedicalsystems.com

. Susan C. Sharpe- susan.sharpe@northside.com

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Tissue arrives in Receiving

Tissue, Receiving Documentation and receipt is checked against the MaterialsManagement computer purchase order # and delivery document generated

ReceivingDeliveryfor all SurgeryAreas

Materials Management employee checks shelves daily, Materials Management copies packing slip anddelivery document. Copies kept and original put with tissue along with any accompanying manufacturer

information/forms

Tissue (along with packing slip, delivery document and any accompanying manufacturer information/forms) istaken to Blood Bank (given to BB employee) by Materials Management employee

Blood Bank employee checks for integrity of tissue packaging

The Blood Bank section of the Tissue Bank record filled out by Blood Bank employee

Attach blue copy to packing slip and delivery document and file in Blood Bank

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Entering room temperature, frozen, refrigerated, lot #, expiration, tissueID into computer (MYSIS database), also document integrity oftissue

package

*Tissue Bank Record of

Tissue Implantation andany accompanyingmanufacturer information/forms will here to forwardbe referred to as

"paperwork"

V\lhite, Yellow and Pink copies of Tissue Bank Record of Tissue ImDlantation (and anv accomDanvinamanufacturer information/formsl. are attached to tissue by Blood Bank employee

Blood Bank employee delivers tissue and paperwork to appropriate department in aspeaficdesgnatedlocation

Products Received Form sgned by Blood Bank and receiving department Leadershipperson or their desgnee, put in speafic location with paperwork.

Operating Room arculator gets tissue(s), takes to OR room, tissue is implanted?

Paperwork (including OR Implant Record) filled out by arculator(Operating Room section only)

Paper work sent to appropriate areas

Yellow copy arrives in Materials Management Dollaramount assgned then sent to Surgery Scheduling

Pink copy arrives in Blood Bank

Input disposition into MYSIS computerdatabase, assign patient demographics

File yellow copy in

Surgery SchedulingMatch blue andpinkcopiestogether,

then file

Completedocumentation

including dispositionof opened but not

used tissue

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Blood Bank TissueProcess

Tissue. Receiving Documentation and receipt is checked against theMaterials Management computer purchase order # and delivery

document generated

Materials Management employee checks shelves daily, Materials Management copies packing slip and delivery document.Copies kept and original put with tissue along with any accompanying manufacturer Informatlonlforms

Tissue (along with packing slip, delivery document and any ac;companying manufacturer informationlforms) istaken to Blood Bank (given to BB employee) by Materials Management employee

Blood Bank employee checks for integrity of tissue packaging

The Blood Bank section of the Tissue Bank record filled out by Blood Bank employee, file blue copy in TissueFile with packing slip and delivery document

Enter tissue in Blood Bank database-BPE, print 2 Products Received Usts (BBR #11)

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Attach specimen bag with BB portion of Tissue Bank Record of Tissue Implantation record completed (and anyaccompanying manufacturer information/forms)

Determine delivery location from the Delivery document

SO in computerBSU to Ground Floor Surgery, Third Roor Surgery, or Meridian Mark

Ground Floor Surgery and Third Floor SurgeryNotify OR Charge Nurse that you are delivering tissue

Meridian Mark SurgeryCall Security for delivery of RTJREFT tissue for this location

Sign 2 copies of Product Received listBlood Bank

Place signed paperworkin file labeled tissueOperating Room

Place paperwork in OrthopedicClinical Supervisor's box

Place tissue in appropriate storage area

After tissue is implanted, completeTissue Bank Record of Implantation

Materials Management-forwardsto Surgery Scheduling,

*Tissue Bank Record of Tissue

Implantation and anyaccompanying manufacturerinfonnation/fonns will here toforward be referred to as

"paperwork"

Tissue arrives in Surgery Area

Non-ReceivingDeliveryforallSurgeryAreas

As soon as possible take to Blood Bank via staff/courier/vendor and waits to take tissue back to surgery

Blood Bank employee checks for integrity of tissue packaging

The Blood Bank section of the Tissue Bank record filled out by Blood Bank employee

Attach blue copy to packing slip and file in Blood Bank

Entering room temperature, frozen, refrigerated, lot #, expiration, tissue ID intocomputer (MYSIS database), also document integrity of tissue package

White, Yellow and Pink copies of Tissue Bank Record of Tissue Implantation (and any accompanyingmanufacturer infonnationlfonnsL. are attached to tissue by Blood Bank employee

Staff/courier/vendor will wait for the tissue to be entered in the Blood Bank system and willdeliver it to the appropriate department

Products Received Fonn signed by Blood Bank and receiving department Leadershipperson or their designee and staff/courier/vendor, put in specific location with paperwork.

Operating Room circulator gets tissue(s), takes to OR room, tissue is implanted

Paperwork (including OR Implant Record) filled out by circulator(Operating Room section only)

Paper work sent to appropriate areas

Yellow copy arrives in Materials Management Dollaramount assigned then sent to Surgery Scheduling

Completedocumentation

including dispositionof opened but not

used tissuePink copy arrives in Blood Bank

Input disposition into MYSIScomputer database, assign

patient demographics

File yellow copy inSurgery Scheduling

Blood Bank generatesoutdate report Outdated Tissue

Blood Bank employee sends tissueoutdate report to appropriate

department in a specific designatedlocation

Operating Room Leadership or theirdesignee is now alerted that expiration.

dates are near

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Operating Room Leadership or theirdesignee fills out all paper work including

company forms

White/yellow copy to Clinical SupervisoriLeadership designee for reorder and

disposal of expired tissuePink copy to Blood Bank

equest to borrow tissuelbone'from another hospital comes to

Leadership

Loaning Tissue toOther Hospitals

Leadership or designee packages (in ice or appropriate substance) for transport

Fillout Tissue Bankingform, stating disposition

to _hospital Fill out Tissue Bankingform, stating dispositionto _hospital

Send Tissue Banking form and any other manufacturer forms to Blood Bank

Loaner form initiated -White copy goes with tissue to other hospital Yellow toLeadership

Hospital receiving the loaned tissuelbone is to reorder, return replacement tissuelbone,notifies Leadership of reorder

Ifno reorder, thenhospital willsend

MaterialsManagement

payment

Replacement tissue/bone arrives

Send to MaterialsManagement to assign charge

TISSUe/bone replacement to be checked into BloodBank and sent to appropriate storage location

IIIIIIIII1Il1[O"/98

NORTHSIDE HOSPITAL

T- BankRecord R4IIUmed to Blood Bank

PO,. RelUmed DatefTime:

Vlalallnapection:

Received by:

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Ti89Je Description: k

Lat!:

REF-caIaIog it:

Donor SpecinEll It:

Sauroe: Human BcMn& Porcine

SUpplier:

Freeze Dried

AllogtaftIrradiatedFreah FIomn

TF~ MMOR NSF (CiICIeone)

Aefrigemor frMzer (Cin:Ieone)

Size orVoIllTle:

D8tefTme:

Operating Room U8e Only

Implantation Reconl

Implant Record CompletedlrrPant Date'Time:Irrpant Swgeon:Inpant Site:-Expil8tion Dale(

Openedfnot implanted: (cirole one)

Diipo8tionIR!8&a1 if ra inpented:

D8fatTi'ne of 8cpilStion:

Techoolqji&t:

Yee or No (Cirdeone)

Techoologist:

RN SignedUre

D8I:elTi me

Oes1inalion: TFS GFS MMOR NSF (Cin::leone)

Storage: SbeIf Aefrigef8lor frMzer (Ciroleone)

Affix TISSUe Identification Label

Traneponer Si!JIalUle:

--.-, -........TtSSUE BANK RECORD OFTISSUE IMPLANTATtON

1l1li11: QlnGll!tNow. arlrf~"._11""-""eUl:lI""'I!8II1~1

~~-.g=='=~=.~==M~'==",,,-->,,- ." ---=-.~..-"",,,."."" .0<.

NORTHSIDE HOSPITAL ATLANTAIMPLANTABLE TISSUE PROCESS

2005

Supplier Qualification

Order Tissue forImplantation

Tissue Received in MaterialsManagement

Tissue Receipt in BloodBank

..--- -------.AnimallHuman Autologous

-----.. .-----Entry into CYRUS tracking

system

Tissue Storage Criteria .

Im~.m::I

Tissue Issue to OR

OR completes TissueBank Record ofImplantation and

retums to Blood Bank

Tissue RetumCriteria

Upclateimplantinformation in

CYRUS

Histologyreturns tissue &forms to Blood

Bank

Tissue AdverseReactions &

Events

Update status inCYRUS

~(Tissue Audit

111-10.2

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AllomatnxCPutty 5ccAllomatnxCPutty 10ccCanceUous4x10mm,15ccCancellous4x10mm,30cc

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pCJw z~ ! ~

860C-0500

B60C-1000

OBA022OBA020

NeuraGenNerveGuide,2mm

NeuraGenNerveGuide,3mmPelvisoft4x7cmPermacol5x10cm

PGN-220

PGN-320481047100510

OR - RETURNEDTISSUE, INDICA1E QUANTI1Y USED AND QUANTITY RETURNED TO BLOOD BANK

ORUSEONLY

ORsignature DatelTime

HISTOLOGYUSEONLY

HistologySignature I,BloodBankSignatureDate&Time

BBForm# TISSUE2005- RT