REVIEW ARTICLES

The Elephant in the Room (and How to Lead It Out): In-Clinic Laboratory Quality Challenges Bente Flatland, DVM, Glade Weiser, DVM

ABSTRACT Over 30 yr of technological evolution have resulted in sophisticated instrumentation for in-clinic laboratories, yet there is no regulatory oversight of diagnostic testing quality. Long overdue, the veterinary profession must address quality assurance (QA) of diagnostic testing. Each practice must weigh the responsibility for laboratory instrumentation test results that are often a combination of in-clinic and send-out testing. Challenges faced by clinic staff maintaining in-clinic laboratories include lack of training in QA and quality control (QC), lack of emphasis placed on QA/QC by instrument suppliers, QC financial and time costs, and a general lack of laboratory QA/QC support resources in the veterinary community. Possible solutions include increased continuing education opportunities and the provision of guidelines and other resources by national veterinary organizations; specialty certification of veterinary technicians; an increasing role of veterinary clinical pathologists as QA/QC consultants; and development of external quality assessment programs aimed at veterinary practices. The potential exists for animal health companies to lead in this effort by innovating instrument design, providing QC services, and exploiting instrument connectivity to monitor performance. Veterinary laboratory QA/QC is a neglected aspect of the profession. In coming years, veterinarians will hopefully find increased support for this core practice component. (J Am Anim Hosp Assoc 2014; 50:375–382. DOI 10.5326/JAAHA-MS-6231)

Introduction

electronic measurements in a flow cell of some type, cell inter-

Diagnostic laboratory testing performed outside the traditional

actions with complex fluid reagents, and data reduction software.1

clinical pathology laboratory may use either instrumental or

Successful operation of those instruments requires not only ad-

noninstrumental test systems and is commonly referred to as

herence to manufacturer instructions, but also regular mainte-

“point-of-care testing” (POCT). Although the term POCT can

nance and quality procedures, in part because instrument

imply certain simplicity compared with instruments used in tra-

performance can degrade over time or can be subject to random

ditional clinical pathology laboratories, the truth is that test sys-

errors, and in part because all hematology instruments have in-

tems marketed for in-clinic use vary widely in technological

herent limitations that quality procedures (such as blood smear

complexity and sophistication. Heartworm antigen tests and

review) ameliorate.2

classic urine dipstick measurements (e.g., pH, glucose, ketones,

In the US, in human medicine, diagnostic laboratory testing is

protein) are examples of simple, noninstrumental test systems

subject to federal regulatory oversight governed by the Clinical

that require simply following manufacturer’s instructions for

Laboratory Improvement Amendments (CLIA) of 1988 and ad-

successful operation. Hematology instruments are among the

ministered by the Centers for Medicare and Medicaid Services.3,4

most complex, involving precise sample pipetting and dilution,

Written to apply to all settings where human disease is diagnosed

From the Department of Biomedical and Diagnostic Sciences, College of Veterinary Medicine, University of Tennessee, Knoxville, TN (B.F.); and Department of Microbiology, Immunology, and Pathology, College of Veterinary Medicine and Biomedical Sciences, Colorado State University, Fort Collins, CO (G.W.).

ACVP, American College of Veterinary Pathologists; AAHA, American Animal

Correspondence: [email protected] (B.F.)

ª 2014 by American Animal Hospital Association

Hospital Association; ASVCP, American Society for Veterinary Clinical Pathology; AVCPT, Academy of Veterinary Clinical Pathology Technicians; CLIA, Clinical Laboratory Improvement Amendments; EQA, external quality assessment; POCT, point-of-care testing; QA, quality assurance; QC, quality control

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and/or treated (from reference laboratories to doctor’s offices),

veterinary in-clinic laboratory testing.6,7 The veterinary commu-

CLIA regulations classify laboratory instruments and test kits

nity knows the elephant is in the room. Now we must find a way to

according to complexity as “high,” “moderate,” or “waived,” and

lead it out! The major motivation for providing high-quality lab-

specify analytical performance criteria (by analyte) that these

oratory services in any veterinary setting clearly is that having high-

instruments and test kits must be able to meet.

3,4

Additionally, for

moderate and high complexity instruments, CLIA specifies quality

quality patient data facilitates high-quality patient care. Minimizing the veterinarian’s liability is a secondary consideration.

procedures that must be carried out in order for providers of testing sites engaged in POCT must either follow CLIA require-

In-Clinic Versus Send-Out Laboratory Testing

ments or choose voluntary accreditation by an approved organi-

Most modern veterinary practices use a combination of in-clinic

zation (by the Centers for Medicare and Medicaid Services) deemed

and send-out (to a reference laboratory) testing. Each veterinary

to promote standards equivalent to, or more stringent than, CLIA.5

practice must weigh the pros and cons of owning and maintaining

laboratory services to meet regulatory requirements.3–5 Laboratory

No such regulatory oversight exists for either veterinary di-

laboratory equipment for their particular circumstances and pa-

agnostic laboratory testing (in any setting) or for manufacturers

tient population. General considerations include time costs (e.g., to

and suppliers bringing laboratory instruments to the veterinary

carry out laboratory testing, instrument maintenance, running of

market. Veterinary clinics owning and maintaining laboratory

controls, and interpretation/management of control and patient

instruments and regularly producing patient laboratory data

data), resource availability (e.g., space, personnel, training), fi-

should consider themselves to be operating a de facto clinical

nancial costs (e.g., costs of instruments, service contracts, con-

pathology laboratory, analogous to a human community hospital

sumable supplies, including attention to expiry dates), and the

laboratory. It is important that veterinarians promote quality of

nature of the patient population served (e.g., considerations for an

laboratory testing from within the profession and that they de-

emergency clinic versus a spay/neuter clinic).2 Likewise, reference

mand more quality assurance (QA) monitoring support from their

laboratories must be carefully selected. General considerations

instrument suppliers. QA refers to laboratory procedures that

include available test menu, cost of testing, data reporting, cus-

monitor and improve laboratory performance and seek to mini-

tomer service, qualifications of laboratory staff (e.g., are clinical

mize error in all phases of testing on an ongoing basis. The term

pathologists board certified? Are staff certified medical technolo-

“quality control” (QC) is most often used to refer specifically to

gists?), and QA practices.8

those procedures that monitor the analytical performance of instruments and detect analytical error. “Running controls” (i.e.,

Challenges

measuring control material) and the subsequent interpretation of

Promoting and improving quality of veterinary in-clinic laboratory

control data are the cornerstones of QC. Over the years, veter-

testing presents significant challenges (Figure 1). A recent survey

inarians themselves have expressed concern about the quality of

conducted via the Veterinary Information Network found that

FIGURE 1

376

Challenges affecting quality of veterinary in-clinic laboratory testing. QA, quality assurance; QC, quality control.

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In-Clinic Laboratory Quality Challenges

most laboratory testing within veterinary clinics is carried out by

patterned after minimal standards for a professional laboratory;

veterinary technicians of varying certification levels.9 Most

however, compliance is optional and is neither monitored nor

respondents were from the US and reported having some form of

regulated. In the middle are numerous and varied recom-

laboratory QA within their clinic, most commonly for hematology

mendations, an example being to analyze control material once

and chemistry testing; however, responses suggested possible

monthly. Some systems have various mechanisms for checking

confusion on the part of respondents about the difference be-

tolerance of selected system components and electronics. A

tween QA and QC, levels of control material, and the running of

problem for the veterinary community is that marketing infor-

controls.9 Ignorance of how to perform QA was the most com-

mation may call this “internal QC” and may imply that those

monly cited reason for lack of an in-clinic QA program.

9

mechanisms are a substitute for performing other QC procedures.

In traditional veterinary clinical pathology laboratories (e.g.,

Although system checks are useful for monitoring and trouble-

academia or commercial diagnostic laboratories), staff typically

shooting purposes, they are not a substitute for analysis of control

include board-certified veterinary clinical pathologists (e.g., Dip-

material (e.g., made from blood or serum; designed to mimic

lomates of the American College of Veterinary Pathologists

a patient sample; and able to test function of the entire system,

[ACVP]) and certified medical technologists (e.g., the American

including instrument, reagents, and operator).10 The absence of

Society for Clinical Pathology). In contrast, laboratory testing in

either control materials or QC recommendations as part of the

veterinary clinical settings (e.g., private veterinary practices and

instrument system package may play to a veterinarian’s concerns

individual hospital wards of academic veterinary medical centers)

about the cost and expertise required to implement a QC pro-

is often carried out by either veterinarians or veterinary technicians

gram. Ironically, some may believe that an instrument system

(or other staff) having no particular training in laboratory tech-

incorporating a QA/QC program is inferior to one that does not

nology or quality management. Some personnel may be part-

(i.e., if a program of regular maintenance and QC is recom-

time employees, and staff turnover may be considerable.

mended, then the instrument must not be as “reliable”). Com-

Training of such personnel within an individual practice may

panies offering instrument systems without control material or

be limited to “how to run a sample and produce a report.”

QC recommendations may unknowingly reinforce the perception

Furthermore, many veterinary technicians and assistants grav-

that QC is not important.

itate to the profession because of interest in one or more aspects

Additional challenges are that all instrument performance

of hands-on animal care or contact; thus, interest in and apti-

degrades over time and that analytical performance capability of

tude for laboratory work is more variable, and some may

POCT instruments may vary, even among instruments of the same

view the need to learn laboratory diagnostics technology as

make and model.11 Assessment of instrument performance is

a necessary evil.

ideally recommended at the time of purchase and on an annual

Although many instruments and test kits used for POCT are

basis thereafter.12

relatively simple (equivalent to CLIA waived categorization), increasing availability and technological sophistication of POCT

Possible Solutions

instrumentation means that some veterinary clinical settings may

Improving the quality of veterinary in-clinic laboratory testing

use more complex instruments (equivalent to CLIA moderately

from within the profession requires a multifaceted approach

complex categorization). Although it is true that instruments

combining support of veterinarians by organized veterinary

marketed for POCT in both human and veterinary medicine are

medicine, appropriately trained (and possibly specialty certified)

simpler (i.e., easier to maintain and use) than instruments mar-

veterinary technicians, instrument suppliers, board-certified

keted to reference laboratories, even the simpler instruments

veterinary clinical pathologists, and external quality assess-

should not simply be considered “plug-in-and-play” devices.

ment (EQA) programs (i.e., proficiency testing) aimed at the

Manufacturer instructions for all aspects of use should be strictly

in-clinic setting.13 Change must necessarily occur incrementally

followed, and daily QA and QC procedures must be in place for

and, in coming years, those diverse resources should ideally

optimal operator and instrument performance to ensure optimal

communicate and converge to develop policies, recommen-

patient data quality.

dations, and guidelines aimed at the in-clinic laboratory setting

Unfortunately, instrument suppliers vary in their recom-

and to provide continuing education opportunities, consulting

mendations regarding QA/QC. One extreme is that QC material is

services, and other resources for veterinarians interested in im-

not available for some instrument systems. The opposite extreme is

proving quality of their in-clinic laboratories. Possible incre-

a recommended program of daily control material analysis

mental changes are outlined below.

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Veterinary Medical Education

examinations than in American ones.15 Something that could

The DVM Curriculum

facilitate greater emphasis on QA/QC topics in American resi-

American Veterinary Medical Association veterinary school ac-

dency curricula is inclusion of American Society for Veterinary

creditation standards state that new veterinary graduates must have

Clinical Pathology (ASVCP) QA/QC guidelines in the clinical

competency in “appropriate use of clinical laboratory testing”. In

pathology specialty boards reading list for candidates (maintained

the authors’ personal experience, QA/QC information is scant in

by the ACVP, the organization that certifies all veterinary pathol-

most veterinary curricula. Given the burden of information over-

ogists). Such a move would ensure that all candidates seeking to

load already affecting veterinary education, detailed training in

qualify for the ACVP certifying examination in clinical pathology

laboratory quality management in the Doctor of Veterinary Med-

become familiar with current ASVCP QA/QC recommendations.

14

icine curriculum does not seem appropriate or necessary. However, newly graduated veterinarians should ideally leave veterinary school

Organized Veterinary Medicine

with a basic understanding of the phases of laboratory testing and

Continuing Education Opportunities

laboratory error and the idea that managing an in-clinic diagnostic

Promotion of QA/QC in the veterinary in-clinic laboratory by

laboratory requires some level of formalized QA/QC within the

national veterinary organizations is essential as described in Table 1.

practice. Additionally, new graduates should ideally have a basic

In coming years, organizations such as the ASVCP, American An-

grasp of the QA/QC-related resources available to them as they set

imal Hospital Association (AAHA), American Veterinary Medical

up and maintain an in-clinic laboratory and seek continuing ed-

Association, National Association of Veterinary Technicians in

ucation on QA/QC topics for themselves and/or their staff.

America, and the Academy of Veterinary Clinical Pathology Technicians will hopefully provide increasing continuing education

Residency Training

opportunities featuring laboratory QA/QC topics through con-

The veterinary specialty having expertise in laboratory quality

tinuing education sessions and workshops aimed at both veter-

management is clinical pathology, and expertise in that subject is

inarians and veterinary technicians. ASVCP, having a membership

acquired by most veterinary clinical pathologists as part of resi-

composed predominantly of board-certified veterinary clinical

dency training and/or through continuing education following

pathologists and certified medical technologists, is a likely source of

completion of a residency. Although current residency training

continuing education speakers on QA/QC topics.

guidelines recommend that residents receive training in principles of QA, including (but not limited to) principles of sample col-

Veterinary Practice Accreditation

lection and handling, types of laboratory error, and principles of

AAHA additionally contributes to quality of veterinary in-clinic

QC, the depth of QA/QC training varies from program to program.

testing through its practice accreditation standards. Current man-

Currently, on average, training in QA/QC is emphasized more

datory AAHA accreditation standards that are relevant to laboratory

heavily in European clinical pathology residencies and certifying

testing list laboratory services that should be available (either via

TABLE 1 National Veterinary Organizations Relevant to Veterinary In-Clinic Laboratory Testing Organization

Acronym

Website

Actual or Theoretical Contribution to Improving Quality of Veterinary In-Clinic Laboratory Testing

American Society for Veterinary Clinical Pathology

ASVCP

www.asvcp.org

Source of QA/QC guidelines freely available via ASVCP website

American Animal Hospital Association

AAHA

www.aahanet.org

Accreditation of veterinary practices

National Association of Veterinary Technicians in America

NAVTA

www.navta.net

Continuing education resource for veterinarians and veterinary technicians Continuing education resource for veterinary technicians

Academy of Veterinary Clinical Pathology Technicians

AVCPT

www.avcpt.net

Source of continuing education speakers on QA/QC topics at ASVCP and other national and regional meetings for both veterinarians and veterinary technicians Some members may provide QA/QC consultation services

NAVTA-approved credentialing organization granting clinical pathology specialty certification to veterinary technicians Continuing education resource for veterinary technicians

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In-Clinic Laboratory Quality Challenges

in-clinic and/or send-out testing) and specify that only trained

error, and QA of POCT. Finalized ASVCP guidelines are freely

practice team members perform in-clinic laboratory testing. Ad-

available under the “Publications” link on their website (available

ditional standards (of which practices seeking accreditation must

at: www.asvcp.org). The ASVCP’s goal is to revise guidelines q 10

meet a specified percentage) contain a list of QA and QC procedures

yr. ASVCP, AAHA, (and possibly the North American Veterinary

16

aimed at reducing laboratory error in all phases of testing.

Technician Association and AVCPT) could also consider developing resources (e.g., workbooks; wall charts; and templates for

Specialty Certification of Veterinary Technicians

forms, logs, and records) that would facilitate implementation of

It seems likely that busy veterinarians will want to continue

QA/QC procedures in veterinary clinics. Dialogue between

leveraging staff to carry out laboratory testing, and veterinary

ASVCP and AAHA regarding promotion of QA/QC in the

technicians are an important contributor to the quality of in-clinic

in-clinic setting is ongoing.18

laboratory testing.13 The Academy of Veterinary Clinical Pathology Technicians ([AVCPT]; the eleventh veterinary technician

Animal Health Diagnostics Companies

specialty) was granted provisional approval by the North Amer-

A potential solution for optimizing performance of veterinary

ican Veterinary Technician Association in November 2011 (full

in-clinic laboratory instruments might be a new, supplier-driven

recognition status is pending the first credentialing examination,

concept of QA/QC services. Historically, laboratory instruments

which is anticipated to occur in 2014). AVCPT’s mission is to

were designed for human health applications with the assumption

promote excellence in the discipline of veterinary clinical pathology

that the operator is well trained in laboratory science and will be

and to certify qualified veterinary technicians in that specialty.17

responsible for all required quality monitoring procedures. With

Certification requirements and knowledge and skills lists can be

integration of computing power and information systems into

found at the AVCPT website (available at: www.avcpt.net). Devel-

modern instruments, the opportunity exists to rethink instrument

opment of that specialty certification for veterinary technicians is

design in a way that automates many aspects of a veterinary clinic’s

exciting because it presents a career path for those veterinary

laboratory quality program and education. In so doing, instru-

technicians with aptitude for and interest in laboratory medicine.

ment suppliers could not only take a leadership role in promoting quality, but could also help reduce the complexity and mystery of

Development of Guidelines and Other Resources

QA/QC procedures for busy staff (although that would not excuse

Through its Quality Assurance and Laboratory Standards Com-

veterinarians and their technicians from having a basic un-

mittee, ASVCP is actively working to develop guidelines on diverse

derstanding of QA/QC). Development of software and data

topics in laboratory quality management aimed at various settings.

monitoring procedures related to QA/QC is an opportunity for

Currently available documents relevant to the in-clinic setting

instrument suppliers to integrate QA/QC recommendations and

include guidelines about reference intervals, allowable total

services into a complete product offering (Figure 2). As an

FIGURE 2

Potential elements of a supplier-provided QC program to be included in the total instrument package. QC, quality control.

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379

example, a study by Hammond et al. (2012) recently investigated

Training and Quality Program Guidance

whether the analytical performance of a hematology instrument

By providing operator guidance in real time, automation of

marketed for veterinary in-clinic use could be monitored and

maintenance and QC procedures (described above) has the po-

adjusted using weighted averages derived from batched patient

tential to be a source of training over time. The instrument-

data. Data from 102 instruments were collected and monitored

operator interface could also be used to provide browser-based

(made possible via the instrument software and manufacturer’s

training modules to eliminate content of user manuals that are,

laboratory information system).19 An interesting application of

in the authors’ experience, rarely used. Interface-delivered training

using patient data to monitor laboratory quality, results from that

modules can be graphical, interactive, and designed to make user

study also showcase how instrument manufacturers can develop

factors more consistent. Modules might cover topics such as the

software and data monitoring procedures capable of improving

need for a key operator, preanalytical sampling handling critical to

in-clinic laboratory results in real time. Some components may

the specific system, unique sample factors that may cause errors,

include the following:

use of control materials, and how the QC program provides automated data interpretation.

Instrument-Operator Interface Historically, limited instrument-operator interfaces and instru-

Connectivity

ment design necessitated detailed operator knowledge and tech-

Modern instrument systems have computing power and con-

nical understanding of not only sample analysis, but also

nectivity enabling bidirectional communication via a network and

maintenance, troubleshooting, and QC procedures. The instrument-

the Internet. With such capability, it is possible to upload system

operator interface of today has the almost endless possibilities of

data to the supplier. As illustrated above, remote data monitoring

a personal computer, including menu navigation on a touch

can allow suppliers to monitor the comparative performance of

screen. Sophisticated user interfaces create potential not only to

a family of field instruments, potentially in an automated manner.

train instrument operators but also to direct instrument operation

Analysis of instrument family trends has the potential to identify

by prompting mandatory maintenance and QC procedures as part

system-wide problems and could be used to aid product im-

of daily operation (including explanations of what is being done).

provement over time. There is also the potential for the supplier

System clocks can be set to recognize daily start-up and other

to send technical bulletins, product alerts, and system soft-

defined intervals and initiate prompts to guide the operator.

ware upgrades directly to the instrument, to be communicated to

Supplier-conceived maintenance and QC procedures specific to the

the user via the instrument-operator interface. For example, data

system can be recommended, and the interface can prompt the

from a family of instruments might identify a reagent lot cali-

operator to analyze control material at prescribed intervals. Intel-

bration factor change that would improve results. That factor

ligent systems can tell the operator whether start-up checks and

change could be uploaded and implemented within that in-

other procedures yield passing results or are completed within

strument family remotely. Additionally, although it seems unlikely

programmed specifications. Control material data can be displayed,

that supplier technical support staff would have the capacity to

archived, and interpreted by system software using preprogrammed

look at all monitored individual systems on a routine basis, in-

evaluative rules. Likewise, intelligent systems can alert the operator if

formation for individual systems could be retrieved for accounts

there is a QC failure or problem and prevent patient sample analysis

either requiring or requesting technical support intervention or

until correction occurs. For specific failures, an interface can be

QC services. Issues that would need to be addressed, should

designed to guide an operator to specific on-board technical doc-

such procedures and services become commonplace, include

umentation (that might be buried within a hard copy technical

data protection, confidentiality, and the logistics of invoicing and

manual) or connect the user to technical support.

billing for services rendered. Finally, using instrument per-

Such reinvention of the instrument-operator interface would

formance data gathered for individual veterinary practices, sup-

basically automate laboratory QC and archive its documentation.

pliers could issue renewable laboratory “certification” designed not

Automation would reduce necessity for conventional extensive

only to provide recognition of a facility’s compliance with

technical training across all instrument operators. With the in-

supplier-recommended QC procedures but also, potentially, to

strument supplier assuming much responsibility for instrument

satisfy accreditation requirements (e.g., AAHA). Veterinary

QC, that approach could standardize QC across veterinary facilities

practices may perceive value in such certification, both for staff

and assert expertise that often is lacking or inconsistent in vet-

pride in the facility and for making such certification known to

erinary practices.

clients.

380

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In-Clinic Laboratory Quality Challenges

QA/QC Consultants

importance of QA/QC, by seeking continuing education on this

QA/QC consulting is a relatively new area for both board-certified

topic, by implementing QA/QC procedures within their practices,

veterinary clinical pathologists and suppliers of instruments aimed

and by consulting instrument manufacturers and other QC spe-

at veterinary settings. It seems likely that, in coming years, both

cialists (e.g., board-certified veterinary clinical pathologists) when

clinical pathologists and instrument manufacturers will offer in-

problems arise or they wish to characterize and/or monitor an-

creased QA/QC consulting services. Private fee-for-service con-

alytical performance of laboratory instruments they possess.13

sulting companies aimed at veterinary laboratories that offer QA/

Veterinarians can additionally seek practice accreditation and

QC services are few, but do exist. Optimal QA/QC consulting

voluntarily follow recommended guidelines from the ASVCP and

requires familiarity with the instrumentation being used and

other national veterinary organizations. Finally, veterinary prac-

ideally involves familiarity with in-clinic laboratory operations

tices maintaining in-house laboratories should consider appointing

(e.g., sample and reagent handling by staff).

a laboratory supervisor or “key instrument operator.” The key operator’s responsibilities could include instrument maintenance,

External Quality Assessment (Proficiency Testing) Programs

quality monitoring, recognizing and troubleshooting problems,

An EQA program, also known as proficiency testing, evaluates

of the laboratory quality program (including maintenance of

a participating laboratory’s total testing performance by com-

written standard operating procedures and training and oversight

paring test results from that laboratory to either a known standard

of other instrument users). Veterinary technicians who have

or to an appropriate peer group mean. Peer group means are

achieved the AVCPT specialty certification will hopefully be well

generated from interlaboratory comparisons in which multiple

qualified to function in such a capacity.

coordination with instrument technical support, and management

laboratories measure the same sample using the same analytical methods, reagents, and controls.20 Data provided to participants

Conclusion

vary by EQA program provider but generally include means,

Promoting and maintaining quality of in-clinic laboratory testing

standard deviations, and other statistics comparing the partici-

presents diverse challenges that must be met incrementally and

pating laboratory’s results to a peer group using the same or

creatively, given the $30 yr period of relative neglect. Successful

similar instrumentation.

21

Identification of an appropriate peer

implementation of an in-clinic veterinary laboratory requires

group to which the participating laboratory’s results can be

support of busy veterinarians by organized veterinary medicine,

compared is critical to successful EQA participation, and a limi-

veterinary technicians, instrument suppliers, QA/QC consultants,

tation of this recommendation for veterinary in-clinic laborato-

and EQA programs. Organized veterinary medicine can play an

ries is that POCT analytical methods are underrepresented in

important role through provision of continuing education, spe-

currently available veterinary EQA programs.

cialty certification of veterinary technicians, and practice accred-

EQA program data can provide valuable perspective on testing

itation standards. There exists potential for instrument suppliers

performance that is independent of the instrument supplier. EQA

to play an important role in in-clinic QC through instrument

program participation can yield data useful for instrument per-

design, provision of QC services, and exploitation of instrument

formance evaluation, QA validation, and accreditation. If available,

connectivity to monitor and adjust instrument performance. Al-

quarterly participation in a suitable EQA program is ideally rec-

though the field of veterinary laboratory QA/QC consulting is

ommended, but participation two or three times each year may be

relatively new, particularly as it relates to veterinary private

sufficient. Importantly, due to its periodic nature, EQA program

practice, it seems likely that this facet of veterinary laboratory

participation is not a substitute for either an in-clinic quality

medicine and the specialty of veterinary clinical pathology will

management program or for the regular analysis of control

continue to grow. Veterinarians will hopefully find increasing

materials. A veterinary EQA guideline is forthcoming from

support for, and resources relevant to, this aspect of their practice

ASVCP, and a guideline on allowable total error for biochemistry

available in the coming years.

testing (relevant to interpretation of EQA data) was recently finalized by ASVCP and published.22

The authors would like to thank many members of the American Society for Veterinary Clinical Pathology and the ASVCP Quality

Veterinarians and Veterinary Technicians

Assurance and Laboratory Standards Committee whose expertise,

Veterinarians and veterinary technicians themselves can promote

project contributions, and advice have shaped the authors’ opin-

the quality of in-clinic laboratory testing by acknowledging the

ions regarding quality assurance/quality control in the in-clinic

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381

laboratory. In particular, the authors thank the following individuals (listed alphabetically): Dr. Kathleen P. Freeman (IDEXX Laboratories, Wetherby, West Yorkshire, UK); Dr. Kendal Harr (Urika

11.

Pathology LLC, Mukilteo, WA); and Dr. Linda Vap (Colorado State University, Fort Collins, CO). The authors also thank Debbie

12.

Gadomski (American Animal Hospital Association National Field Operations Manager) for enhancing their understanding of American Animal Hospital Association accreditation requirements.

13. 14.

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The elephant in the room (and how to lead it out): In-clinic laboratory quality challenges.

Over 30 yr of technological evolution have resulted in sophisticated instrumentation for in-clinic laboratories, yet there is no regulatory oversight ...
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