second generation automation at oregon ......tat qi values before and after the dmaic project figure...

Early Adoption of Automation in the OHSU Transfusion Service

As the state’s only Academic Health Center and Research

University, OHSU brings together education, research, patient

care and community service. OHSU laboratories offer a full range

of laboratory and pathology services, including specialized tests

and referrals for unusual laboratory procedures. As a progressive

institution, OHSU has been one of the early adopters of automation

for their Transfusion Service laboratories.

OHSU brought their first generation Blood Bank automation in

2006 and was able to run ~1900 types and screens (T&Ss) per

month, a rate that increased when they add a second instrument

in November of 2011.

Reaching a Crossroad

Despite the original benefit of an improved turnaround using

automation for all T&Ss running through the lab, the Transfusion

Service laboratory found itself at a crossroad just a few years

later; some minor updates to the current system could improve

productivity slightly, but greatly increased productivity could only

The Transfusion Service of OHSU has substantially increased productivity while reducing cost and staffing. With the introduction of 2 Grifols Erytras at the end of 2015, the lab was able to automate

>90% of their testing menu, while increasing

productivity >200%.

For product information, visit us at diagnostic.grifols.com©2018 Grifols International, S.A. All rights reserved worldwide.

SECOND GENERATION AUTOMATION AT OREGON HEALTH & SCIENCE UNIVERSITY: AN AUTOMATION OPPORTUNITYWith their new, integrated-lab automation system, OHSU drastically improved productivity.

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TRANSFUSION MEDICINE: A CUSTOMER TESTIMONIAL

Oregon Health and Science

University and Transfusion

Service 2017

· The only Academic Health Center

in the state of Oregon, based in

Portland and established in 1887

· 16,000 employees, 19 sites

including 2 hospitals and one of

the top-ranked adult and children

hospitals (Doernbecher)

· 576 licensed beds (145 pediatrics)

· Healthcare admissions and

medical clinic patients – Adults:

203,937, Pediatrics: 6,822

· Level 1 trama center

· 50 OR suites operating 24-hours

daily, 7 days per week

(continued on back panel)

be achieved through automating a much

higher percentage of testing. Off shifts were

staffed by generalists and OHSU wanted to

better accommodate generalists doing testing,

while minimizing the number of personnel

needed to do the ever increasing test volume

they were experiencing. How could the TAT/

productivity be further increased under these

conditions? OHSU understood that they had to

completely rethink their automation strategy.

There was general agreement on the benefits

of gel technology - minimal training, no wash

steps and result stability - and that the Blood

Bank needed to stay with gel. Following a

thorough evaluation OHSU purchased their

first Erytra in September 2015 and have been

satisfied with that decision.

Important benefits from switching

to 2 Erytras

Moving to 2 Erytras reduced the number

of manual workstations from two to one.

Also, Erytras offered several highly desirable

features such as indicating an accurate time

to completion of sample runs which helped

technicians to precisely plan and maximize

their workday around automation. The most

impressive and important advantage, however,

was the substantial decrease in TAT. The 2

Erytras were able to complete >90% of all

T&Ss in less than 60 minutes, a goal which they

had never realized with their first generation

instruments. Several features of the Erytra were

responsible for this important reduction in

turnaround time:

· 2 sampling probes that pipet faster

· Continuous feed (meaning samples can be loaded at any time)

· Individual results sent to the LIS for validation in real time and not per batch

In addition, the laboratory was able to

automate other tests that were previously

performed manually, further increasing the lab’s

productivity (antibody panels, neonatal T&S,

lgG Gel cross matches and cord blood types).

OHSU is now able to put all donor unit retypes,

approximately 1300/ month on the Erytras. The

previous instruments did not have the capacity

to handle both unit retypes and recipient

type and screens without slowing turnaround.

With manual testing, donor retypes were not

interfaced and required manual entry into

the LIS. These shortcomings were completely

eliminated using the Grifols Erytras.

What key factors should be considered

when choosing an automated system?

At OHSU, there were several parameters

that needed to be taken into account to

assure satisfaction with a new automated

system: Besides ease of operation, automated

downloading of results to the LIS was equally

desirable. Specimen processing had to be

optimal, including effective reading of the

patient barcodes, processing of pediatric micro

containers, and the option of STAT testing. Last,

but not least, one should check the frequency

and ease of maintenance steps as well as the

quality of trouble shooting guidelines and Mean

Time between Failure (MTF) information.

Conclusion

Replacing old instrumentation with two

Erytras, has resulted in almost complete

automation of testing menu offered at OHSU

Transfusion Service laboratory. Starting at 55%

of automation before the implementation of

the Erytras, the lab is now at 97%. Furthermore,

an impressive gain has also allowed the lab to

reach its TAT goal for the first time in 5 years.

Grifols Diagnostic Solutions Inc.4560 Horton StreetEmeryville, CA 94608 USATel: +1 888 244 7667diagnostic.grifols.com

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Achieving Workflow Efficiency & Reducing Turnaround Time (TAT) in a Lean Six Sigma Laboratory Experience of TriCore Reference Laboratories at the University of New Mexico Hospital

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For product information, visit us at diagnostic.grifols.com

DIAGNOSTICS GRIFOLS ERYTRA: INNOVATION IN LABORATORY AUTOMATION

(continued on back)

TriCore Reference Laboratories (TRL)

· Independent, not-for-profit, full service reference laboratory

· Largest provider of laboratory testing in New Mexico

· Established in 1998 following the merger of laboratories from 3 entities:

- The University of New Mexico Hospital

- Presbyterian Healthcare Services

- The Reference Laboratory

Testing volumes· T&S at UH: ~23,000 per year· 76% being “priority” samples

Introducing TriCore Reference Laboratories (TRL)

TriCore Reference Laboratories (TRL) services fourteen distinct hospital laboratory locations, including the University of New Mexico Hospital (UNMH), the only Level 1 Trauma Center in New Mexico (NM), and Presbyterian Hospital, the largest acute care hospital in NM. “Effective laboratory testing is an important component to the quality of care,” says Dr. Kendall Crookston, one of the associate medical directors at TriCore. “Laboratory automation offers the opportunity to improve the efficiency of laboratory operations and helps us to streamline workflows and test processes. Ultimately this allows us to maximize our testing outputs and save costs considerably.”

“At TRL, turnaround time (TAT) is our key indicator for measuring the efficiency of a testing platform and the performance of our laboratory,” adds Ivana F. Bononcini, laboratory manager, not without a tad of pride over their highly optimized work environment that delivers timely and consistent results.

Critical clinical decisions depend on a fast, predictable TAT to optimize patient care. Using the Grifols automation solution combined with thorough evaluation based on the Lean Six Sigma allowed the lab to achieve and implement an optimized workflow in their blood bank laboratory.

Implementation of Grifols Erytra and optimization of workflow

During the second quarter 2016, TRL initiated a large-scale transition from solid phase to Grifols Gel testing solutions across its entire laboratory system. One Erytra and one Wadiana were successfully qualified and validated at the UNMH site. During the second quarter of 2017, the Wadiana was replaced by a second Erytra in order to satisfy the ever-growing testing volume (Figure 1).

The partnership with Grifols allowed TRL to:· See gains in efficiency and productivity· Increase the laboratory testing capacity within existing infrastructure

and without additional labor resources· Standardize testing processes across the different sites· Achieve instrument scalability across its laboratories


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The DMAIC Lean Six Sigma Project

In order to guarantee its patient care-centric mission and meet the high demand of STAT T&S tests, UNMH established a quality indicator to monitor its turnaround time (TATQI). This TATQI is defined as 90% of the samples completed from “Receive-to-Result” in less than 60 minutes.

Before implementation of the Grifols Gel solution, the measured TATQI was reported at 93.25%. Subsequent TATQI values after the implementation averaged at 83.34% for the period of May 2016 through July 2017 (Figure 1).

Given this concerning trend, a Lean Six Sigma project or DMAIC (Define, Measure, Analyze, Improve, and Control) was undertaken between August 2018 and October 2018. Following this analysis, the following improvements were implemented:

· Optimization of the work environment around the Erytra® workstations to directly impact the staff ergonomic requirements (Figure 2)

· Refining the sequence of tasks to reduce delays

· Separating and coordinating related tasks for technicians on day shift to achieve a seamless workflow

The impact of these arrangements resulted in measurable improvement of the TATQI with an average of 90% of samples resulted within 60 minutes. In addition, the laboratory was able to achieve a remarkable average time for a T&S of 48 minutes and 34 seconds three months into the improvement efforts (Table 1).

Conclusion

In order to fully achieve operational effectiveness following the implementation of the Grifols gel solutions, UNMH transfusion medicine laboratory performed a Lean Six Sigma analysis that identified areas of improvement throughout their T&S process. As shown in this case, each laboratory should clearly define a process for integrating automation into their workflow. Such analysis should not only focus on instrument qualifications and intra-laboratory evaluation, but also identify additional areas of improvement in order to maximize the benefits of automation.

Erytra Key Attributes:

Advantages:· Flexibility for different lab configurations · Scalability with Erytra Eflexis

and manual stations · Very quiet: 45 dBA · Optimizes STAT sample management · Small footprint: 43" x 28" x 69" (w x d x h)

Features:· Capacity: 350 cards · Sample Loading Capacity: up to 96 · Throughput: T&S 48 samples/hr (3C)

Figure 2. Work station before and after DMAIC

Before After

1 Technician can sit or stand throughout the shift or rotation (table height adjusts by pressing button). 2 Front end is closer to the Grifols workstation for better verbal communication on receiving STAT. 3 Centrifuges are within reach while sitting or standing. 4 Incoming orders on the printer are plainly visible and within reach. 5 Specimens on the Erytra® are easier to monitor for completeness.

Start Date End DateNumber of T&S

Average time for T&S (minutes)

Average TAT ≤60 minutes (%)

Aug 2018 9/26/2018 696 55.72 70

Oct 2018 10/10/2018 248 48.57 89

Feb 2019 10/16/2018 214 49.83 92

Table 1. TATQI values before and after the DMAIC project

Figure 1. UNMH: Cost saving over a 6-month period

$161,429

11,313 Tests

Pre-Grifols (Jul-Dec 2015)

$109,400

12,278 Tests

Post-Grifols (Jan-Jun 2017)

200K

150K

100K

50K

Workload increase: 8.3%Cost reduction: 32.2%

1

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Grifols Erytra: Implementation of a NewAutomated System for MultiCare Health System Significant Improvement in Turnaround Time and Reduction of False Positives

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For product information, visit diagnostic.grifols.com

TRANSFUSION MEDICINE: HOSPITAL-BASED CUSTOMER TESTIMONIALS

The MultiCare Health System

MultiCare Allenmore Hospital, TacomaMultiCare Auburn Medical Center, AuburnMultiCare Covington Medical Center, CovingtonMultiCare Deaconess Hospital, SpokaneMultiCare Good Samaritan Hospital, PuyallupMary Bridge Children’s Hospital, TacomaMultiCare Tacoma General Hospital, TacomaMultiCare Valley Hospital, Spokane Valley

2018 MultiCare Patient Volume: · Emergency Department Visits: 375,510· Admissions: 63,649· Inpatient Surgeries: 15,571· Births: 8,689

Western Transfusion Services: · T&S tests: about 24,000/year· Blood component units provided

for transfusion: about 20,000 including: - Red cells: 13,000 - Plasma, FFP, and Platelets: 7,000

The MultiCare Health System has achieved considerable reduction of tech hands-on time while effectively reducing the number of false positive results. With the introduction of an Erytra to their transfusion service reference lab late in 2018, MultiCare was able to gain more than 1000 hours of valuable tech time that has been used to improve the quality of service offered to nurses and doctors. Considerable reduction of false positive samples, on the other hand, favorably affects patients' treatment and time spent in the hospital.

Headquartered in Tacoma, Washington, the MultiCare Health System is a not-for-profit health care organization that includes eight hospitals across the Puget Sound and Eastern Washington regions. MultiCare Health System offers a comprehensive list of services covering primary care, urgent care, numerous specialties, as well as a Level II Pediatric trauma center (Mary Bridge Children’s Hospital) and a level IV Neonatal Intensive Care Unit (MultiCare Tacoma General Hospital).

MultiCare’s transfusion laboratories provide full service in most of the western hospitals, with partial Type & Screen (T&S) testing at Covington as well as in the two eastern hospitals. The transfusion laboratory at MultiCare Tacoma General Hospital serves the immunohematology reference laboratory for complex cases resolution.

Until June 2017, MultiCare was using an automated solid phase system (Echo®, Immucor) with the contract expiring in August 2018. In June 2017, a request for information (RFI) was initiated for selection of a new automated analyzer. Tenders were received from three different manufacturers with immunohematology automates: Immucor (Galileo Echo®), Ortho (Vision®), and Grifols (Erytra®). Fifty-seven criteria were defined and ranked in order of importance by 70 transfusion medicine laboratory staff across the system. A decision tree based on these criteria was developed according to their importance under the coordination of Mike Charapata MBA, MT(ASCP)SBBCM, Manager, Transfusion Services at MultiCare Health System. Factors ranked as most important by the staff included time of load, turn-around-time, reproducibility of results, maintenance time, footprint, noise level, test menu, FDA approval, and, last but not least, overall cost.

The results of the on-site evaluation were in favor of the Grifols Erytra based on several key factors such as time of load, turn-around-time, footprint, noise level, maintenance (hands-on and downtime during maintenance), and reproducibility of results. Subsequent to these evaluations, the Erytra and its DG Gel technology were successfully implemented across the MultiCare transfusion laboratory network and went live on October 29, 2018. After a year of routine testing on the new platform, it was time to evaluate its performance within the laboratory system as compared to historical data.

(continued on back)

The Erytra instrument in Mike Charapata's laboratoryMike Charapata MLT, MBA, Manager, Transfusion Services


Tech hands-on time Historically, it took approximately 2 minutes 10 seconds in the pre-analytical phase for samples, reagents preparation and loading each sample on the Echo. With the Erytra, these tasks are now completed in an average of less than 30 seconds per sample. (Table 1)

“All in all, there is about a 100 second difference per sample,” explained Mike, “meaning that per year we save about 40,000 minutes (650 hours) based on our testing volume for T&S. This represents a significant gain of tech time!”

He added, “If one adds up all time used for daily, monthly, and yearly maintenance, the Erytra requires only 5 minutes hands-on per day for maintenance. With the Echo, the hands-on time was approximately 21 minutes per day. Thus again we are saving around 15 minutes hands-on time per day for maintenance, which brings us to 90 hours saved per year. If you consider that we use the Erytra at our four main sites, we are talking about more than 360 hours of hands-on time saved for our techs. Adding on the 650 hours gained during sample preparation and loading steps, we are at over 1,000 hours saved!”

The time gained per tech is used for improving customer service for doctors, nurses, and general problem solving. In addition, MultiCare’s staff can spend more time on other activities in the lab such as blood inventory management, ultimately resulting in increased productivity.

Specificity The increased specificity of the Erytra compared to the Echo translated into 1-3 fewer reflex antibody identifications per month for non-specific positive antibody screen results. “Although this may not sound like it has a significant effect, for these 1-3 patient(s) the impact is considerable, resulting in faster blood supply and contributing towards

a shorter length of hospital stay,” noted Mike. Similarly, the much stronger Anti-D reactions obtained with the Erytra translates into 5 fewer additional Weak D workups per month. Taken together, 6-8 patients per month receive their blood faster thanks to the improved sample turn around at the MultiCare labs.

Grifols as the single provider at MultiCare Hospital System Finally, yet most importantly, working with Grifols as the unique provider allowed standardization of testing processes across the laboratories. Besides Grifols excellent customer support, working with one single provider has critical advantages from operational and managerial aspects.

Based on his experience, Mike found that besides achieving much better pricing for reagents once you work with the Grifols instruments, the standardization throughout the labs reduced the workload for administrators considerably. Training processes, SOPs, competency programs, staffing models and interface setups only have to be developed and updated for one single system. “For the administration, this is huge and saves an incredible amount of time and resources. In addition, technologists do not have to be retrained when transferred from one hospital site to the other. They hit the ground running.”

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Product registration and availability vary by country. Ask your local Grifols representative for more information.

ERYTRA GALILEO ECHO

Daily Check for any liquids that have leaked or been spilled*Check for unwanted microbial growth*Remove reagents from storage and warm to room temperature**Empty solid and liquid waste container (as needed)**Add additional Wash A and Wash B solutions (as needed)**

Initialize the instrument*Clean the instrument* Check the probe alignment* Check the probe vertical position* Clean probe** Prime probe** Washer residual volume test (visual)** Remove reagents from storage and warm to room temperature**

Weekly Clean the surfaces, if necessary*Restart the instrument** Backup database**

Shut down the instrument and computer*Archiving results and deleting from the database*

Monthly Decontaminate the instrument and its components* Decontamination (decontaminate/flush/purge/prime)*Wiping down the probe block* Performing the washer residual volume test* Performing the washer dispense accuracy*

Total monthly hands-on time

2.5 hours 10.5 hours

Average daily hands-on time

5 minutes 21 minutes

Table 1: Instrument maintenance steps per MultiCare SOP

*indicated in IFU as "routine" task / **indicated in IFU as "as-needed" task; Taken from MultiCare SOP, Erytra instructions for use and Galileo Echo instructions for use.

Figure 1: Specificity

Annual average number of non-specific positive antibody screen results

Echo®2014–2018

Erytra®2018–2019

97

86

78 120

73 103

Grifols Erytra: Implementation of a New Automated System at Duke Regional Hospital Significant Improvement in Turnaround Time, Efficiency, and Productivity

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TRANSFUSION MEDICINE: HOSPITAL-BASED CUSTOMER TESTIMONIALS

Duke Regional Hospital

· Established in 1998 following the merger of laboratories from 3 entities:

- The 3 affiliated hospitals

- Employing about 12,000 people in Clinical Laboratory Medicine throughout the health system

· Mid-sized with 360 beds

· Over 500 staff physicians

· Affiliated with Duke University Schools of Medicine and Nursing

· Level 3 Trauma Center; University Hospital Level 1 Trauma Center

· 100,000 ED visits /year

· 200-300 obstetrical deliveries/month

· 3,000 surgeries/month

· Blood bank data (monthly)

- 1350 to 1500 type & screens

- 550-650 crossmatches

· 100 antibody identifications

Introduction

Duke Regional Hospital is one of the three hospitals comprising the Duke University Health System. With 360 beds and over 500 dedicated physician staff members, Duke Regional Hospital is a Level 3 trauma center that provides the Durham, NC community every possible medical service in a convenient community hospital environment. Patients at DRH have access to Duke University Health System expertise including a Level 1 trauma center, burn care, and transplant service, located at the affiliated Duke University hospital nearby.

Debie Lynn DeCrescenzo, laboratory supervisor of transfusion services, joined the Duke University Health System in late 2015 with an immediate need to update the laboratory’s aging Ortho ProVue, which had been in use at DRH for over 12 years. Debie's previous experience managing multiple blood banks (and more recently working as consultant in Texas) meant that DRH had vast experience in the first generation of automated blood bank platforms. “I had a very good idea of what instrumentation I wanted to pursue before arriving at Duke,” explains Debie. Looking back on the ProVue specifically at DRH, Debie identified that technicians initially loved the Provue. However, the longer they worked with it, its functional limitations became increasingly frustrating. Additionally, when considering other automated systems, Debie was keen to avoid false positive and negative results and increased disposable costs that she had observed previously with solid phase platforms.

After performing extensive research on new automation, Duke Regional Hospital identified that they needed to move to a gel-based, cost-effective solution that could meet their services’ testing needs. DRH, along with their affiliate Duke Raleigh Hospital, standardized their pretransfusion testing by selecting the Grifols Erytra as the next generation of automation for their transfusion services at both sites. (continued on back)

The Erytra Key Attributes:

Advantages:· Flexibility for different lab configurations · Scalability with Erytra Eflexis and manual stations · Very quiet: 45 dBA · Optimizes STAT sample management · Small footprint: 43" x 28" x 69" (w x d x h)

Features:· Capacity: 350 cards · Sample loading capacity: up to 96 · Throughput: T&S 48 samples/hr (3C)


Grifols Erytra Impact on Productivity at DRH

In the fall, immediately prior to the delivery of the Grifols Erytra, DRH lost a blood bank technician to another department at Duke University Health System, with no option to replace the headcount. Staff at DRH initially had reservations about the extra workload. Although additional stress was placed on the transfusion service throughout the installation and validation of the Erytra, once go live occurred, several features of the Erytra allowed DRH to streamline their workflow. The net effect from the loss of headcount was absorbed and, simultaneously, DRH reduced turnaround time for testing and increased throughput (see Table 1).

One area the Erytra had an enormous impact on at DRH was patient care, specifically with oncology and dialysis patients. “Since the Erytra replaced the ProVue at DRH, blood products are now available to these patients within 40 minutes or less. Previously this was 70 minutes,” stresses Debie. When laboratory testing reveals these patients require transfusion, DRH reports that patients will not need to make an extra trip to the hospital, and providers are happy that their patients leave the clinic without symptomatic anemia or other health concerns.

DG Gel Detected Antibodies Previously Not Detected

DRH reports that validation of the Erytra was exceedingly straightforward. Each validation specimen was tested on the Erytra using DG Gel

and reagents. On the ProVue, each was tested using the lab’s current gel and reagents. In addition, samples were tested in manual tube and manual gel using both the lab’s current gel and Grifols DG Gel. “We performed this massive validation and obtained 100% concordance,” explains Debie. “Surprisingly, we had a few specimens where Grifols reagents detected antibodies previously not detected in evidence.” During validation, DRH reported that low frequency antibodies anti-Kpa, anti-Lua, and anti-Cw were detected using Grifols DG Gel system, but had not been detected during initial antibody screenings. DRH transfusion service identified Grifols reagent red cells to be the key in detecting these low frequency antibodies. Debie states, “Initial antibody screenings had not detected these antibodies because the screening cells we’d been using didn’t encompass these antigens. It’s nice to have a clear, clinical picture.”

Partnership Drives Laboratory Efficiencies

Purchasing, installing, and validating a new analyzer is a large undertaking for laboratories. Selecting the right partner—beyond just reagents and automation—is also very important. “I’ve purchased many different pieces of equipment, but this is the first time where a company helped us organize absolutely everything,” Debie states. Grifols project management allowed DRH to streamline training, validation, procedure generation, and optimize standing orders. “We even have a recycling program for our shipping boxes!” Debie says.

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Table 1: Advantages and Features of the Erytra as reported by the DRH lab personnel

FEATURES PROVUE ERYTRA

Blood product availability 60-90 minutes 40 minutes

Efficiency: comparisonFirst sample of 12 T&S still pending at 29 minutes

12 T&S completed in 29 ½ minutes

Loading Batching of samples required Continual loading possible shortening turn-around times

STAT Routine sample interruption No process interruption

Wash buffer Prepare frequently Prepare once a day - the analyzer can hold much larger volumes

Reagent wastage - RBCs High for red cells Probe is able to aspirate the last drop of red cells due to the tilted block holding the reagent red cell vials

Product registration and availability vary by country. Ask your local Grifols representative for more information.

FDA APPROVED FOR USE:

Grifols Blood Grouping Reagents (BGR) and Antihuman Globulin (AHG) 21 blood grouping reagents and 3 antihuman globulin reagents (IgG + C3d, IgG, and C3d)

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Higher efficacy of Grifols reagents versus comparable FDA-approved reagents allows for a considerable savings in time and cost.

Principal investigator:

John D. Roback, MD, PhDClinical Pathology and Laboratory Medicine

Site investigators:

Gregory Denomme, PhD, FCSMLS(D) Blood Research Institute, BloodCenter of Wisconsin, Milwaukee, WI

Monica Kalvelage, MS, MT(ASCP)SBBReferee, Director of Laboratory Services, LifeShare Blood Centers, Shreveport, LA

Sandra Nance, MS, MT(ASCP)SBBImmunohematology Reference Laboratories, American Red Cross, Pacific Northwest, Portland, OR and American Red Cross, Northeastern Pennsylvania Scranton, PA

Study Facts:

· 11,604 patient and donor samples were tested at 5 clinical sites using both Grifols and FDA-approved reagents and instruments – 45,695 data points generated in total

· Samples adequately represented the US population in hospitals and blood centers

· Comparison assays included tube test, microplate, solid phase, and molecular

· Ease of reagent use – results demonstrate that laboratory personnel with different backgrounds and experience levels can successfully use the Grifols Blood Group Reagents (BGR) and AHG

· Higher efficacy of Grifols reagents versus FDA-approved comparators allows savings of time and costs

(continued on back panel)

TRANSFUSION MEDICINE: A STUDY OF BLOOD GROUPING REAGENTS


Antisera Comparison Guide

ANTISERUM INCUBATION TIME IAT (Y/N) COMMENT

Grifols Anti-Jka/Anti-Jkb None N

Manufacturer #2 15' N

Manufacturer #3 5'-15' N

Manufacturer #4 5' N

Manufacturer #5 N/A N/A Reagents not supplied

Grifols Anti-C/Anti-c/Anti-E/Anti-e None N No additional testing for negative results (NR)


Manufacturer #3 5' Y Additional testing required for NR

Manufacturer #4 None N Additional testing required for NR

Manufacturer #5 5'-15'/5'-15' N

Grifols Anti-K None N



Manufacturer #4 15' Y

Manufacturer #5 15'-45’ Y

Background

Monoclonal antibodies (mAbs) are highly specific reagents and may vary in efficacy and reactivity. Variations are mostly due to differences in specificity, affinity, and selection of a single antibody clone (different companies may use different clones). The quality of red blood cell (RBC) antigen typing and antibody identification may hence be considerably impacted. Thus, it is important to evaluate performance and accuracy of mAbs from different companies and sources before any usage in routine lab testing.

Current blood grouping reagents (BGR) used in serological tube testing offer a variety of options with regards to production (monoclonal vs monoclonal blend vs polyclonal), incubation times, temperature, centrifugation time, and requirement for an indirect antiglobulin test (IAT).

The Grifols BGR offers several advantages and testing options that are worthwhile to be outlined:

· Strength of agglutination: equal to or better (anti-Fyb) than comparable reagents currently used in laboratories

· Consistent and reliable results for all antisera specificities: no incubation time needed for anti-Jka, -Jkb, -K, -M and no additional testing in case of negative results (NR) when using Grifols BGR. Thus, patients benefit from a more rapid turnaround time

· No incubation time and no IAT for the Grifols monoclonal anti-Fyb. This anti-Fyb detects Fyb weak samples known to be missed by some currently distributed anti-Fyb reagents

Lab Goals

Enhance patient care Safer and effective results using FDA-approved Grifols reagents

Improve turnaround time Timely results with enhanced reactivity*

Reduce costs More immediate spin testing which eliminates incubation time and indirect antiglobulin testing

*Abstract ID: 4394 Performance Evaluation of New Monoclonal Blood Grouping and Anti-Human Globulin Reagents for Serological Testing. Abstract ID: 4399 New Human Monoclonal IgM Anti-Fyb Reagent Shows Stronger Reactivity for the Detection of Weak Fyb Antigen.

2018 AABB Annual Meeting, October 13-16, 2018 in Boston, MA.

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OREGON HEALTH & SCIENCE UNIVERSITY_DLBTS302180013_FinalTriCore Reference Laboratories_DGBTS305190014_FinalMultiCare_US-BTS4-1900001_FinalDuke Regional Hospital_DGBTS305190015_FinalSTUDY OF BLOOD GROUPING REAGENTS_DLBTS1110180024_Final

second generation automation at oregon ......tat qi values before and after the dmaic project figure...

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