It’s Time for In-House Quality Assurance
Laboratory testing has always been an important part of veterinary practice, and advances in technology have allowed veterinarians to bring more testing in-house. Each day’s flood of new product information brings with it still another supplier’s literature loudly trumpeting the ability of their products to provide veterinarians with the important clinical data needed for timely medical decisions.
There is one problem, however. Where we used to extract a tooth, we now perform a root canal. Where we used to remove a femoral head, we implant a gleaming artificial hip joint. Where we used to euthanize animals with cancer, we administer chemotherapy; yet, the vast majority of veterinary practices still run test after in-house test with little to no means for verifying the accuracy of their test results, just as it was done 15 or 20 years ago! Although we’ve made great strides, still missing from most of our now robust in-house testing programs is some form of laboratory quality assurance (QA).
While the current manufacturers of in-house testing equipment have done a superb job of training their veterinarian customers as to the uses of their products, this writer believes that they have done a woeful job of educating practitioners with regard to the critical role that QA plays in the laboratory setting. Are suppliers concerned that practitioners will view QA programs as an additional cost with no obvious benefit? Are they concerned that the inclusion of quality control procedures will cause practitioners to view their products as perhaps more complicated than they actually are? Do they fear that routine quality control runs might expose their analytical systems to closer scrutiny? Instead of being relatively mute on the need for laboratory quality control, equipment manufacturers should be partnering with the profession in an educational effort to achieve the very best and most accurate patient results.
A thorough discussion of even the basic components of a laboratory QA program is beyond the scope of this commentary, although many good references are readily available.12 Suffice it to say that from a practitioner’s standpoint, a laboratory QA program need only have one goal—assuring him or her that the test results posted to the patient’s record are both accurate and precise. This unshakable level of confidence can only be achieved when we utilize methods that carefully monitor the performance of the equipment, the integrity of the reagent system, and the ability of our staff to perform those tests correctly.
Such methods include routine testing of preassayed control materials with successful recovery of assigned target values. “Built-in” quality control products or methods are helpful in some instances, but they can never cover all of the possible scenarios that might cause an otherwise good test to go bad. Documentation of scheduled preventative maintenance and calibration must also be included in this scheme.
In addition to instituting a standardized in-house QA program, veterinarians should be subscribing to an external QA program such as the one currently offered through the Veterinary Laboratory Association. These programs are often referred to as proficiency testing programs, and enrollment would allow practitioners to compare the performance of their own in-clinic laboratory with other hospital laboratories utilizing the same equipment by processing “unknown” specimens and reporting those test results to the program provider for tabulation and statistical analysis. Organizations such as the AAHA, whose purpose is to promote high standards of care within its members’ hospitals through the establishment of practice standards and practice accreditation, could easily take the lead by adding a standardized laboratory QA program (including both internal and external components) to its list of member hospital requirements. Wouldn’t practitioners rest easier knowing that the patient who’s taken to the clinic down the street or to the specialist across town for a second opinion won’t leave him or her embarrassed or (worse yet) liable when an erroneous test result surfaces?
In 1988 the US federal government mandated strict QA guidelines for all physician office laboratories when it was discovered that physicians were also reporting patient results without proper validation. As the caretakers of animal health, we veterinarians have a golden opportunity to take a higher road by instituting our own such programs from within. While there are no guarantees that such a move would keep government inspectors out of our practices, I suspect that it will only be a matter of time if we don’t.
As our profession enters the third millennium, we find at our disposal awesome new tools like surgical lasers, ultrasound, and various forms of telemedicine with which we can provide a quality of health care far beyond any we might have ever imagined. However, in-house laboratory testing conducted in the absence of a QA program has no place in this bold new world of practice. I believe that veterinarians are and always have been among the most caring and responsible professionals. This profession has before it yet another opportunity to demonstrate that.
Response
On behalf of the American Animal Hospital Association, I would like to thank Dr. Mitzner for his thoughtful editorial. Current AAHA practice accreditation standards include the following laboratory quality assurance requirements:
All in-house laboratory services performed must be carried out by competent personnel using approved standard laboratory procedures. The quality-control system within the pathology laboratory must be designed to ensure medical reliability of laboratory data.
For in-house laboratory procedures, equipment must be operated and evaluated according to the manufacturer’s recommendations and have a written protocol of operation.
A record of the quality-control tests and maintenance procedures performed on all laboratory equipment must be maintained.
For outside-laboratory procedures, a current letter from the outside laboratory(ies) must be available assuring that a quality-control program is in effect. The outside laboratory(ies) should participate at least annually in proficiency surveys and/or reference sample services covering all types of analyses performed to verify competence.
While these standards are consistent with Dr. Mitzner’s recommendations, they apply only to 4-year accredited practices. In addition, in-house laboratories are not required to provide assurance of participation in an external proficiency testing program. Coincidentally, the AAHA Standards Enhancement Task Force, which is in the process of reviewing all AAHA accreditation standards (including those involving laboratory services), is considering these points.
Once again, I would like to thank Dr. Mitzner for his timely recommendations. His suggestions will be given serious consideration as enhanced accreditation standards are developed during the coming months.
