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 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.
Introduction
Diagnostic laboratory testing performed outside the traditional clinical pathology laboratory may use either instrumental or noninstrumental test systems and is commonly referred to as “point-of-care testing” (POCT). Although the term POCT can imply certain simplicity compared with instruments used in traditional clinical pathology laboratories, the truth is that test systems marketed for in-clinic use vary widely in technological complexity and sophistication. Heartworm antigen tests and classic urine dipstick measurements (e.g., pH, glucose, ketones, protein) are examples of simple, noninstrumental test systems that require simply following manufacturer’s instructions for successful operation. Hematology instruments are among the most complex, involving precise sample pipetting and dilution, electronic measurements in a flow cell of some type, cell interactions with complex fluid reagents, and data reduction software.1 Successful operation of those instruments requires not only adherence to manufacturer instructions, but also regular maintenance and quality procedures, in part because instrument performance can degrade over time or can be subject to random errors, and in part because all hematology instruments have inherent limitations that quality procedures (such as blood smear review) ameliorate.2
In the US, in human medicine, diagnostic laboratory testing is subject to federal regulatory oversight governed by the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and administered by the Centers for Medicare and Medicaid Services.3,4 Written to apply to all settings where human disease is diagnosed and/or treated (from reference laboratories to doctor’s offices), CLIA regulations classify laboratory instruments and test kits according to complexity as “high,” “moderate,” or “waived,” and specify analytical performance criteria (by analyte) that these instruments and test kits must be able to meet.3,4 Additionally, for moderate and high complexity instruments, CLIA specifies quality procedures that must be carried out in order for providers of laboratory services to meet regulatory requirements.3–5 Laboratory testing sites engaged in POCT must either follow CLIA requirements or choose voluntary accreditation by an approved organization (by the Centers for Medicare and Medicaid Services) deemed to promote standards equivalent to, or more stringent than, CLIA.5
No such regulatory oversight exists for either veterinary diagnostic laboratory testing (in any setting) or for manufacturers and suppliers bringing laboratory instruments to the veterinary market. Veterinary clinics owning and maintaining laboratory instruments and regularly producing patient laboratory data should consider themselves to be operating a de facto clinical pathology laboratory, analogous to a human community hospital laboratory. It is important that veterinarians promote quality of laboratory testing from within the profession and that they demand more quality assurance (QA) monitoring support from their instrument suppliers. QA refers to laboratory procedures that monitor and improve laboratory performance and seek to minimize error in all phases of testing on an ongoing basis. The term “quality control” (QC) is most often used to refer specifically to those procedures that monitor the analytical performance of instruments and detect analytical error. “Running controls” (i.e., measuring control material) and the subsequent interpretation of control data are the cornerstones of QC. Over the years, veterinarians themselves have expressed concern about the quality of veterinary in-clinic laboratory testing.6,7 The veterinary community knows the elephant is in the room. Now we must find a way to lead it out! The major motivation for providing high-quality laboratory services in any veterinary setting clearly is that having high-quality patient data facilitates high-quality patient care. Minimizing the veterinarian’s liability is a secondary consideration.
In-Clinic Versus Send-Out Laboratory Testing
Most modern veterinary practices use a combination of in-clinic and send-out (to a reference laboratory) testing. Each veterinary practice must weigh the pros and cons of owning and maintaining laboratory equipment for their particular circumstances and patient population. General considerations include time costs (e.g., to carry out laboratory testing, instrument maintenance, running of controls, and interpretation/management of control and patient data), resource availability (e.g., space, personnel, training), financial costs (e.g., costs of instruments, service contracts, consumable supplies, including attention to expiry dates), and the nature of the patient population served (e.g., considerations for an emergency clinic versus a spay/neuter clinic).2 Likewise, reference laboratories must be carefully selected. General considerations include available test menu, cost of testing, data reporting, customer service, qualifications of laboratory staff (e.g., are clinical pathologists board certified? Are staff certified medical technologists?), and QA practices.8
Challenges
Promoting and improving quality of veterinary in-clinic laboratory testing presents significant challenges (Figure 1). A recent survey conducted via the Veterinary Information Network found that most laboratory testing within veterinary clinics is carried out by veterinary technicians of varying certification levels.9 Most respondents were from the US and reported having some form of laboratory QA within their clinic, most commonly for hematology and chemistry testing; however, responses suggested possible confusion on the part of respondents about the difference between QA and QC, levels of control material, and the running of controls.9 Ignorance of how to perform QA was the most commonly cited reason for lack of an in-clinic QA program.9
Citation: Journal of the American Animal Hospital Association 50, 6; 10.5326/JAAHA-MS-6231
In traditional veterinary clinical pathology laboratories (e.g., academia or commercial diagnostic laboratories), staff typically include board-certified veterinary clinical pathologists (e.g., Diplomates of the American College of Veterinary Pathologists [ACVP]) and certified medical technologists (e.g., the American Society for Clinical Pathology). In contrast, laboratory testing in veterinary clinical settings (e.g., private veterinary practices and individual hospital wards of academic veterinary medical centers) is often carried out by either veterinarians or veterinary technicians (or other staff) having no particular training in laboratory technology or quality management. Some personnel may be part-time employees, and staff turnover may be considerable. Training of such personnel within an individual practice may be limited to “how to run a sample and produce a report.” Furthermore, many veterinary technicians and assistants gravitate to the profession because of interest in one or more aspects of hands-on animal care or contact; thus, interest in and aptitude for laboratory work is more variable, and some may view the need to learn laboratory diagnostics technology as a necessary evil.
Although many instruments and test kits used for POCT are relatively simple (equivalent to CLIA waived categorization), increasing availability and technological sophistication of POCT instrumentation means that some veterinary clinical settings may use more complex instruments (equivalent to CLIA moderately complex categorization). Although it is true that instruments marketed for POCT in both human and veterinary medicine are simpler (i.e., easier to maintain and use) than instruments marketed to reference laboratories, even the simpler instruments should not simply be considered “plug-in-and-play” devices. Manufacturer instructions for all aspects of use should be strictly followed, and daily QA and QC procedures must be in place for optimal operator and instrument performance to ensure optimal patient data quality.
Unfortunately, instrument suppliers vary in their recommendations regarding QA/QC. One extreme is that QC material is not available for some instrument systems. The opposite extreme is a recommended program of daily control material analysis patterned after minimal standards for a professional laboratory; however, compliance is optional and is neither monitored nor regulated. In the middle are numerous and varied recommendations, an example being to analyze control material once monthly. Some systems have various mechanisms for checking tolerance of selected system components and electronics. A problem for the veterinary community is that marketing information may call this “internal QC” and may imply that those mechanisms are a substitute for performing other QC procedures. Although system checks are useful for monitoring and troubleshooting purposes, they are not a substitute for analysis of control material (e.g., made from blood or serum; designed to mimic a patient sample; and able to test function of the entire system, including instrument, reagents, and operator).10 The absence of either control materials or QC recommendations as part of the instrument system package may play to a veterinarian's concerns about the cost and expertise required to implement a QC program. Ironically, some may believe that an instrument system incorporating a QA/QC program is inferior to one that does not (i.e., if a program of regular maintenance and QC is recommended, then the instrument must not be as “reliable”). Companies offering instrument systems without control material or QC recommendations may unknowingly reinforce the perception that QC is not important.
Additional challenges are that all instrument performance degrades over time and that analytical performance capability of POCT instruments may vary, even among instruments of the same make and model.11 Assessment of instrument performance is ideally recommended at the time of purchase and on an annual basis thereafter.12
Possible Solutions
Improving the quality of veterinary in-clinic laboratory testing from within the profession requires a multifaceted approach combining support of veterinarians by organized veterinary medicine, appropriately trained (and possibly specialty certified) veterinary technicians, instrument suppliers, board-certified veterinary clinical pathologists, and external quality assessment (EQA) programs (i.e., proficiency testing) aimed at the in-clinic setting.13 Change must necessarily occur incrementally and, in coming years, those diverse resources should ideally communicate and converge to develop policies, recommendations, and guidelines aimed at the in-clinic laboratory setting and to provide continuing education opportunities, consulting services, and other resources for veterinarians interested in improving quality of their in-clinic laboratories. Possible incremental changes are outlined below.
Veterinary Medical Education
The DVM Curriculum
American Veterinary Medical Association veterinary school accreditation standards state that new veterinary graduates must have competency in “appropriate use of clinical laboratory testing”.14 In the authors’ personal experience, QA/QC information is scant in most veterinary curricula. Given the burden of information overload already affecting veterinary education, detailed training in laboratory quality management in the Doctor of Veterinary Medicine curriculum does not seem appropriate or necessary. However, newly graduated veterinarians should ideally leave veterinary school with a basic understanding of the phases of laboratory testing and laboratory error and the idea that managing an in-clinic diagnostic laboratory requires some level of formalized QA/QC within the practice. Additionally, new graduates should ideally have a basic grasp of the QA/QC-related resources available to them as they set up and maintain an in-clinic laboratory and seek continuing education on QA/QC topics for themselves and/or their staff.
Residency Training
The veterinary specialty having expertise in laboratory quality management is clinical pathology, and expertise in that subject is acquired by most veterinary clinical pathologists as part of residency training and/or through continuing education following completion of a residency. Although current residency training guidelines recommend that residents receive training in principles of QA, including (but not limited to) principles of sample collection and handling, types of laboratory error, and principles of QC, the depth of QA/QC training varies from program to program. Currently, on average, training in QA/QC is emphasized more heavily in European clinical pathology residencies and certifying examinations than in American ones.15 Something that could facilitate greater emphasis on QA/QC topics in American residency curricula is inclusion of American Society for Veterinary Clinical Pathology (ASVCP) QA/QC guidelines in the clinical pathology specialty boards reading list for candidates (maintained by the ACVP, the organization that certifies all veterinary pathologists). Such a move would ensure that all candidates seeking to qualify for the ACVP certifying examination in clinical pathology become familiar with current ASVCP QA/QC recommendations.
Organized Veterinary Medicine
Continuing Education Opportunities
Promotion of QA/QC in the veterinary in-clinic laboratory by national veterinary organizations is essential as described in Table 1. In coming years, organizations such as the ASVCP, American Animal Hospital Association (AAHA), American Veterinary Medical Association, National Association of Veterinary Technicians in America, and the Academy of Veterinary Clinical Pathology Technicians will hopefully provide increasing continuing education opportunities featuring laboratory QA/QC topics through continuing education sessions and workshops aimed at both veterinarians and veterinary technicians. ASVCP, having a membership composed predominantly of board-certified veterinary clinical pathologists and certified medical technologists, is a likely source of continuing education speakers on QA/QC topics.
Veterinary Practice Accreditation
AAHA additionally contributes to quality of veterinary in-clinic testing through its practice accreditation standards. Current mandatory AAHA accreditation standards that are relevant to laboratory testing list laboratory services that should be available (either via in-clinic and/or send-out testing) and specify that only trained practice team members perform in-clinic laboratory testing. Additional standards (of which practices seeking accreditation must meet a specified percentage) contain a list of QA and QC procedures aimed at reducing laboratory error in all phases of testing.16
Specialty Certification of Veterinary Technicians
It seems likely that busy veterinarians will want to continue leveraging staff to carry out laboratory testing, and veterinary technicians are an important contributor to the quality of in-clinic laboratory testing.13 The Academy of Veterinary Clinical Pathology Technicians ([AVCPT]; the eleventh veterinary technician specialty) was granted provisional approval by the North American Veterinary Technician Association in November 2011 (full recognition status is pending the first credentialing examination, which is anticipated to occur in 2014). AVCPT's mission is to promote excellence in the discipline of veterinary clinical pathology and to certify qualified veterinary technicians in that specialty.17 Certification requirements and knowledge and skills lists can be found at the AVCPT website (available at: www.avcpt.net). Development of that specialty certification for veterinary technicians is exciting because it presents a career path for those veterinary technicians with aptitude for and interest in laboratory medicine.
Development of Guidelines and Other Resources
Through its Quality Assurance and Laboratory Standards Committee, ASVCP is actively working to develop guidelines on diverse topics in laboratory quality management aimed at various settings. Currently available documents relevant to the in-clinic setting include guidelines about reference intervals, allowable total error, and QA of POCT. Finalized ASVCP guidelines are freely available under the “Publications” link on their website (available at: www.asvcp.org). The ASVCP’s goal is to revise guidelines q 10 yr. ASVCP, AAHA, (and possibly the North American Veterinary Technician Association and AVCPT) could also consider developing resources (e.g., workbooks; wall charts; and templates for forms, logs, and records) that would facilitate implementation of QA/QC procedures in veterinary clinics. Dialogue between ASVCP and AAHA regarding promotion of QA/QC in the in-clinic setting is ongoing.18
Animal Health Diagnostics Companies
A potential solution for optimizing performance of veterinary in-clinic laboratory instruments might be a new, supplier-driven concept of QA/QC services. Historically, laboratory instruments were designed for human health applications with the assumption that the operator is well trained in laboratory science and will be responsible for all required quality monitoring procedures. With integration of computing power and information systems into modern instruments, the opportunity exists to rethink instrument design in a way that automates many aspects of a veterinary clinic's laboratory quality program and education. In so doing, instrument suppliers could not only take a leadership role in promoting quality, but could also help reduce the complexity and mystery of QA/QC procedures for busy staff (although that would not excuse veterinarians and their technicians from having a basic understanding of QA/QC). Development of software and data monitoring procedures related to QA/QC is an opportunity for instrument suppliers to integrate QA/QC recommendations and services into a complete product offering (Figure 2). As an example, a study by Hammond et al. (2012) recently investigated whether the analytical performance of a hematology instrument marketed for veterinary in-clinic use could be monitored and adjusted using weighted averages derived from batched patient data. Data from 102 instruments were collected and monitored (made possible via the instrument software and manufacturer's laboratory information system).19 An interesting application of using patient data to monitor laboratory quality, results from that study also showcase how instrument manufacturers can develop software and data monitoring procedures capable of improving in-clinic laboratory results in real time. Some components may include the following:
Citation: Journal of the American Animal Hospital Association 50, 6; 10.5326/JAAHA-MS-6231
Instrument-Operator Interface
Historically, limited instrument-operator interfaces and instrument design necessitated detailed operator knowledge and technical understanding of not only sample analysis, but also maintenance, troubleshooting, and QC procedures. The instrument-operator interface of today has the almost endless possibilities of a personal computer, including menu navigation on a touch screen. Sophisticated user interfaces create potential not only to train instrument operators but also to direct instrument operation by prompting mandatory maintenance and QC procedures as part of daily operation (including explanations of what is being done). System clocks can be set to recognize daily start-up and other defined intervals and initiate prompts to guide the operator. Supplier-conceived maintenance and QC procedures specific to the system can be recommended, and the interface can prompt the operator to analyze control material at prescribed intervals. Intelligent systems can tell the operator whether start-up checks and other procedures yield passing results or are completed within programmed specifications. Control material data can be displayed, archived, and interpreted by system software using preprogrammed evaluative rules. Likewise, intelligent systems can alert the operator if there is a QC failure or problem and prevent patient sample analysis until correction occurs. For specific failures, an interface can be designed to guide an operator to specific on-board technical documentation (that might be buried within a hard copy technical manual) or connect the user to technical support.
Such reinvention of the instrument-operator interface would basically automate laboratory QC and archive its documentation. Automation would reduce necessity for conventional extensive technical training across all instrument operators. With the instrument supplier assuming much responsibility for instrument QC, that approach could standardize QC across veterinary facilities and assert expertise that often is lacking or inconsistent in veterinary practices.
Training and Quality Program Guidance
By providing operator guidance in real time, automation of maintenance and QC procedures (described above) has the potential to be a source of training over time. The instrument-operator interface could also be used to provide browser-based training modules to eliminate content of user manuals that are, in the authors' experience, rarely used. Interface-delivered training modules can be graphical, interactive, and designed to make user factors more consistent. Modules might cover topics such as the need for a key operator, preanalytical sampling handling critical to the specific system, unique sample factors that may cause errors, use of control materials, and how the QC program provides automated data interpretation.
Connectivity
Modern instrument systems have computing power and connectivity enabling bidirectional communication via a network and the Internet. With such capability, it is possible to upload system data to the supplier. As illustrated above, remote data monitoring can allow suppliers to monitor the comparative performance of a family of field instruments, potentially in an automated manner. Analysis of instrument family trends has the potential to identify system-wide problems and could be used to aid product improvement over time. There is also the potential for the supplier to send technical bulletins, product alerts, and system software upgrades directly to the instrument, to be communicated to the user via the instrument-operator interface. For example, data from a family of instruments might identify a reagent lot calibration factor change that would improve results. That factor change could be uploaded and implemented within that instrument family remotely. Additionally, although it seems unlikely that supplier technical support staff would have the capacity to look at all monitored individual systems on a routine basis, information for individual systems could be retrieved for accounts either requiring or requesting technical support intervention or QC services. Issues that would need to be addressed, should such procedures and services become commonplace, include data protection, confidentiality, and the logistics of invoicing and billing for services rendered. Finally, using instrument performance data gathered for individual veterinary practices, suppliers could issue renewable laboratory “certification” designed not only to provide recognition of a facility's compliance with supplier-recommended QC procedures but also, potentially, to satisfy accreditation requirements (e.g., AAHA). Veterinary practices may perceive value in such certification, both for staff pride in the facility and for making such certification known to clients.
QA/QC Consultants
QA/QC consulting is a relatively new area for both board-certified veterinary clinical pathologists and suppliers of instruments aimed at veterinary settings. It seems likely that, in coming years, both clinical pathologists and instrument manufacturers will offer increased QA/QC consulting services. Private fee-for-service consulting companies aimed at veterinary laboratories that offer QA/QC services are few, but do exist. Optimal QA/QC consulting requires familiarity with the instrumentation being used and ideally involves familiarity with in-clinic laboratory operations (e.g., sample and reagent handling by staff).
External Quality Assessment (Proficiency Testing) Programs
An EQA program, also known as proficiency testing, evaluates a participating laboratory’s total testing performance by comparing test results from that laboratory to either a known standard or to an appropriate peer group mean. Peer group means are generated from interlaboratory comparisons in which multiple laboratories measure the same sample using the same analytical methods, reagents, and controls.20 Data provided to participants vary by EQA program provider but generally include means, standard deviations, and other statistics comparing the participating laboratory’s results to a peer group using the same or similar instrumentation.21 Identification of an appropriate peer group to which the participating laboratory's results can be compared is critical to successful EQA participation, and a limitation of this recommendation for veterinary in-clinic laboratories is that POCT analytical methods are underrepresented in currently available veterinary EQA programs.
EQA program data can provide valuable perspective on testing performance that is independent of the instrument supplier. EQA program participation can yield data useful for instrument performance evaluation, QA validation, and accreditation. If available, quarterly participation in a suitable EQA program is ideally recommended, but participation two or three times each year may be sufficient. Importantly, due to its periodic nature, EQA program participation is not a substitute for either an in-clinic quality management program or for the regular analysis of control materials. A veterinary EQA guideline is forthcoming from ASVCP, and a guideline on allowable total error for biochemistry testing (relevant to interpretation of EQA data) was recently finalized by ASVCP and published.22
Veterinarians and Veterinary Technicians
Veterinarians and veterinary technicians themselves can promote the quality of in-clinic laboratory testing by acknowledging the importance of QA/QC, by seeking continuing education on this topic, by implementing QA/QC procedures within their practices, and by consulting instrument manufacturers and other QC specialists (e.g., board-certified veterinary clinical pathologists) when problems arise or they wish to characterize and/or monitor analytical performance of laboratory instruments they possess.13 Veterinarians can additionally seek practice accreditation and voluntarily follow recommended guidelines from the ASVCP and other national veterinary organizations. Finally, veterinary practices maintaining in-house laboratories should consider appointing a laboratory supervisor or “key instrument operator.” The key operator's responsibilities could include instrument maintenance, quality monitoring, recognizing and troubleshooting problems, coordination with instrument technical support, and management of the laboratory quality program (including maintenance of written standard operating procedures and training and oversight of other instrument users). Veterinary technicians who have achieved the AVCPT specialty certification will hopefully be well qualified to function in such a capacity.
Conclusion
Promoting and maintaining quality of in-clinic laboratory testing presents diverse challenges that must be met incrementally and creatively, given the ≥30 yr period of relative neglect. Successful implementation of an in-clinic veterinary laboratory requires support of busy veterinarians by organized veterinary medicine, veterinary technicians, instrument suppliers, QA/QC consultants, and EQA programs. Organized veterinary medicine can play an important role through provision of continuing education, specialty certification of veterinary technicians, and practice accreditation standards. There exists potential for instrument suppliers to play an important role in in-clinic QC through instrument design, provision of QC services, and exploitation of instrument connectivity to monitor and adjust instrument performance. Although the field of veterinary laboratory QA/QC consulting is relatively new, particularly as it relates to veterinary private practice, it seems likely that this facet of veterinary laboratory medicine and the specialty of veterinary clinical pathology will continue to grow. Veterinarians will hopefully find increasing support for, and resources relevant to, this aspect of their practice available in the coming years.
Challenges affecting quality of veterinary in-clinic laboratory testing. QA, quality assurance; QC, quality control.
Potential elements of a supplier-provided QC program to be included in the total instrument package. QC, quality control.
Contributor Notes
