Point-of-care testing in an organprocurement organization donormanagement setting

One integral part of donor management thatmaximizes recovery of high quality organs fortransplantation is the timely receipt of laboratorytesting results for oxygenation management, fluidand blood product management, and detection oflethal electrolyte abnormalities. The clinician canthen make management changes faster when labor-atory results are available. That may allow thetransplantable organs to be of higher quality as wellas allow those offers to be made more expeditiously.With the development of point-of-care testing(POCT), our organ procurement organization(OPO) wanted to determine whether this could beused in managing our donors.

In an effort to increase efficiency of the donorprocess and to reduce donor costs, the MidwestTransplant Network Organ Procurement Organ-ization decided to investigate the feasibility ofdonor POCT, which gives the organ procurementnurse the ability to perform certain tests at thedonor’s bedside rather than sending specimens tothe hospital laboratory. The impacts evaluatedwere:

• correlation of POCT results with hospital labor-atory methodologies;

• impact on donor management;• financial impact;

Baier KA, Markham LE, Flaigle SP, Nelson PW, Shield CF, Muruve NA,Aeder MI, Murillo D, Bryan CF. Point-of-care testing in an organprocurement organization donor management setting.Clin Transplant 2003: 17 (Suppl. 9): 48–51. � Blackwell Munksgaard, 2003

Abstract: Purpose: Our organ procurement organization (OPO) evaluatedthe clinical and financial efficacy of point-of-care testing (POCT) in man-agement of our deceased organ donors.Methods: Before we implemented point-of care testing with the i-STAT intoroutine clinical donor management, we compared the i-STAT result withthe result from the respective donor hospital lab (DHL) for certain analyteson 15 consecutive donors in our OPO from 26 March to 14 May 2001. Thefinancial impact was studied by reviewing 77 donors from July 2001 toMarch 2002.Results: There was a strong correlation for each analyte between the POCand DHL test results with r-values as follows: pH 0.86; PCO2 ¼ 0.96;PO2 ¼ 0.98; sodium ¼ 0.98; potassium ¼ 0.95; chloride ¼ 0.94;BUN ¼ 0.98; glucose ¼ 0.92; haematocrit ¼ 0.87 and creatinine ¼ 0.95.Since our OPO coordinators began using i-STAT in their routine clinicalmanagement of organ donors, they can now more quickly maximize oxy-genation and fluid management of the donor and make extra-renal place-ment calls sooner. Finally, since we are no longer being billed for the testingperformed on the i-STAT, average financial savings to our OPO are $733per case.Conclusions: Point-of-care testing in management of our OPO donorsprovides a result that is equivalent to that of the donor hospital lab, hasquicker turn-around time than the donor hospital laboratory, allowingmore immediate clinical management decisions to be made so thatextra-renal offers may begin sooner.

K A Baier, L E Markham,S P Flaigle, P W Nelson,C F Shield, N A Muruve, M I Aeder,D Murillo and C F Bryan

Midwest Transplant Network, Westwood, KS,

USA

Key words: i-STAT – donor management – test

turn-around time

Corresponding author: Karen A. Baier, Midwest

Transplant Network, 1900 West 47th Place,

Suite 400, Westwood, KS 66205, USA.

Tel: +1 913 262 1668; Fax: +1 913 262 5130;

E-mail: kbaier@mwob.org

Clin Transplant 2003: 17 (Suppl. 9): 48–51Copyright � Blackwell Munksgaard 2003

ISSN 1399-6738

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• ease of use and maintaining competency fororgan procurement coordinators in four geo-graphical locations within our OPO.

Materials and methods

Point-of-care testing using the i-STAT

We chose the i-STAT System (i-STAT Corpora-tion, East Windsor, NJ, distributed by AbbottLaboratories, Chicago, IL) for its portability andease of use (1, 2). POCT is performed using i-STATcartridges and the i-STAT Portable Clinical Ana-lyzer. Tests performed are: pH, PCO2 and PO2(Cartridge G3+), sodium, potassium, chloride,BUN, glucose and haematocrit (Cartridge 6+)and creatinine (Cartridge Crea).Donor samples are tested at the bedside using

40–95 lL of whole blood (2–3 drops) obtainedfrom an arterial line. The disposable single-usecartridges contain microfabricated sensors, cali-brant solution, fluidics system, and waste chamber.A cartridge is filled with blood and inserted intothe battery-operated i-STAT Portable ClinicalAnalyzer for analysis. The analyser automaticallycontrols the fluid movement within the cartridge,calibration, and continuous quality monitoring.Operator and patient identification numbers areentered during the testing cycle. The results aredisplayed when patient testing is complete. Oncompletion of a donor case, all results are down-loaded to the central data station for data man-agement and permanent storage (3).

Study design

In March 2001, the coordinators began using atleast three sets of point-of-care tests parallel withthe hospital laboratory testing when on site at thetime of donor management. When a case wascompleted, the hospital laboratory was contactedto identify the instruments and methodologies usedfor the testing performed there. Comparisons wereconducted on 15 consecutive donors in our OPOfrom 26 March to 14 May 2001. The correlationcoefficient (r-value) for the i-STAT values andthe hospital laboratory values were calculated(Table 1).The financial impact was determined by review-

ing 94 donors over an 11-month period, with anaverage of 4.2 blood gas cartridges, 3.0 electrolyte/BUN/Glucose cartridges, and 3.0 creatininecartridges used per case. The hospital charges forthese tests were calculated by averaging theamounts charged for the testing from severaldifferent hospital laboratories. The cost of the

i-STAT cartridges was then subtracted from theaverage hospital charges, resulting in the netsavings for each type of testing performed per case(Table 2).

Results

The turn-around time for the tests performed usingthe i-STAT system was reduced from 1 h or more(typical time for a hospital laboratory result to beobtained) to 6–10 min (analytic time per cartridgeis just over 2 min), allowing coordinators moretimely intervention of donor management and theability to begin extra-renal organ placement calls atleast an hour sooner.The data in Table 1 show that there was a

high correlation between the results obtainedusing the i-STAT system and the hospital labor-atories. The average r-value for the 11 analyteswas 0.94.

Table 1. Correlation of i-STAT results with donor hospital laboratory results

Analyte

Number of donorsamples compared(i-STAT vs. hospitallaboratory)

Correlationcoefficient

pH 25 0.86pCO2 25 0.96pO2 25 0.98HCO3 25 0.94Sodium 98 0.98Potassium 31 0.95Chloride 29 0.94Glucose 29 0.92BUN 23 0.98Creatinine 28 0.95Haematocrit 29 0.87

Table 2. Financial impact of donor point-of-care testing – 1 July 2001 –30 June 2002

i-STATcartridge

No. of i-STATtests/case

Average hospitallaboratorycharge/case

Averagei-STATcost/case

Net savings/casea

ABGs(94 donors)

4.2 (398 cartridges) $462 $29 $433

Electrolytes(94 donors)

3.0 (299 cartridges) $231 $24 $207

Creatinine(94 donors)

3.0 (305 cartridges) $102 $9 $93

Total – – – $733

Average savings per case ¼ $733.Annual savings based on 100 donors ¼ $73 300.a(Average hospital laboratory charge/cost) minus (average i-STAT cost/case).

Point-of-care testing in OPO donor management

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The financial impact using POCT is shown inTable 2. When the costs/case of the i-STATcartridges were subtracted from the hospital labor-atory charges, the net savings was $733/case,making the annual savings for every 100 donors,$73 300.There are, however, costs associated with the

initial performance verification studies for theanalyser and cartridges, and with the ongoingverification that is required throughout the year.Precision studies are performed initially at a costof $1030, and only need to be performed once foras many analysers that are used. Linearity verifi-cation must be done bi-annually at an approxi-mate cost of $676 per analyser. Running liquidcontrols is required each time a cartridge lotnumber changes, at a cost of $77 per lot numberchange for all three types of cartridges. During the11 months of analysis in this study, the total costfor performance verification and quality controlwas $1030 for precision studies, $3380 for linearityverification of five analysers, and $616 for lotnumber quality control (eight new lot numbers),for a total of $5026. The non-testing cost for useof the i-STAT system for the 94 donors in thisstudy was $53.00. The cost would be even less inthose settings where multiple analysers are notnecessary. The costs associated with quality con-trol of the test system were minimal comparedwith the savings that can be realized by utilizingPOCT.The i-STAT programme is supervised by the

manager of the OPO-associated HLA laboratorywho is responsible for instrument verification,quality control, and the user competency pro-gramme. An initial training and follow-up compe-tency programme has been set up for all i-STATusers (including our satellite locations [outsideKansas City] of Joplin, MO, Columbia, MO andWichita, KS) that includes rotation of proficiencytesting samples. Table 3 summarizes the profi-ciency testing (PT) results from the College ofAmerican Pathologists (CAP) Critical Care/Aque-ous B Gas Survey that we use for i-STAT. It isimportant to emphasize that when each CAPSurvey arrives, five different OPO Coordinatorsperform testing on the different analytes. Thosedata show that of 135 events, we successfullyresponded in 134 (98%) of them. Furthermore,since the CLIA 1988 regulations require successfulparticipation in a PT programme, the CAP PTreport indicates that we are in compliance withCLIA 1988 PT regulations (CLIA also receives acopy of the CAP report). The system is straight-forward to operate and the competency pro-gramme ensures that all users maintain expertise.

Discussion

POCT in the management of organ donors byOPO coordinators has now been shown to be animportant adjunct in the management of an OPO’sdonors. The most important reason for integratingPOCT into our donor management protocol is thatwe receive the lab results so much faster (6–10 minfor an entire battery of tests rather than about anhour for the donor hospital lab to return theresults). Quicker turn-around time thus allows ourOPO coordinators to more quickly adjust clinicalmanagement. We feel that the timely clinicalmanagement should improve the quality of organswe recover for transplantation by allowing us tomake management adjustments more rapidly thanwhen we relied on results from the donor hospitallab. The quicker turn-around time for POCT hasalso allowed our OPO coordinators to begin theirextra-renal organ placement calls sooner (by asmuch as 1 h). That may make it possible for ourOPO to place more extra-renal organs for trans-plantation by allowing for more placement time.The second important reason for implementing

POCT in our regular donor management protocolis the amount of money it should save on each case.As can be seen in Table 2, we save on average $733per organ donor case, which translates to over$73 000 for every 100 donors our OPO recovers.The ability to reduce the cost by that amountwithout �losing� any data is an important reasonthat other OPOs may want to consider this option.The final point to make regarding the imple-

mentation of POCT in the OPO setting relates tosetting up and running the entire i-STAT pro-gramme. Effective August 20, 2002, OPOs arerequired to comply with the requirements set forthin 42 CFR Part 493 (CLIA 1988) (4). Since our

Table 3. Summary of Midwest Transplant Network CAP Proficiency Testingfor i-STAT (Critical care/Aqueous B Gas Survey) for three proficiency sur-veys, 2001 (n ¼ 1) and 2002 (n ¼ 2)

Analyte

No. of acceptableregulatedresponses Total Percent

Cumulative CLIA1988 performanceinterpretation

Blood gas, pH 15 15 100% SuccessfulBlood gas, PO2 15 15 100% SuccessfulBlood gas, PCO2 15 15 100% SuccessfulChloride 15 15 100% SuccessfulCreatinine 14 15 93% SuccessfulGlucose 15 15 100% SuccessfulPotassium 15 15 100% SuccessfulSodium 15 15 100% SuccessfulUrea nitrogen 15 15 100% SuccessfulAll routine chemistry 134 135 98% Successful

Baier et al.

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OPO-based HLA laboratory is CLIA 1988 andCAP accredited, we have decided to be accreditedby the CAP for our i-STAT use to meet therequirements for CLIA licensure (CAP has CLIAdeemed status).Requirements for a certificate of accreditation

under CLIA 1988 include:

• participation in proficiency testing (Table 3illustrates the quite successful results by ourOPO staff for CAP Surveys in 2001 and 2002);

• a system for patient test management;• a system for meeting quality control require-ments, including verification of method perform-ance specifications, equipment maintenance andfunction checks, calibration verification proce-dures, control procedure, and remedial actionplan;

• personnel qualifications for Laboratory Direc-tor, Technical Consultant, Clinical Consultant,and testing personnel;

• a quality assurance programme designed tomonitor and evaluate the overall quality of theentire testing process;

• inspections conducted by CMS or one of itsdeemed agencies, such as CAP (5).

The important message is that management ofi-STAT implementation and regulation compliance

is done most easily by laboratory professionalswho are familiar with the regulations of CLIA 1988and CAP. However, an OPO without a laboratorycan be successful in setting up a POCT programmewithin the guidelines of CLIA 1988 with adequatetraining. The Association of Organ ProcurementOrganizations (AOPO) has incorporated POCTstandards into their accreditation process. It istherefore critical that OPO coordinators learn theappropriate steps to comply with all regulationsthat apply to their accreditation.

References

1. i-STAT. i-STAT System Manual. Windsor, NJ: i-STATCorporation, 2001.

2. i-STAT. i-STAT Implementation Guide. Windsor, NJ:i-STAT Corporation, 1999.

3. Midwest Transplant Network. Midwest TransplantNetwork i-STAT Procedure Manual. Westwood, KS:Midwest Transplant Network, 2001.

4. Department of Health and Human Services. Applica-bility of the Clinical Laboratory Improvement Amendments(CLIA) to the Monitoring of Organs Before Recovery andTransplantation, ACTION, August 20, 2002. Washington,DC: Centers for Medicare and Medicaid Services Memo-randum, 2002.

5. Anonymous. CRF Part 493. Federal Register, 4, 1992: 57(40): 7137.

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