Introduction
The first article in this series introduced the concepts of a total quality management system and a quality plan for in-clinic laboratories. The purpose of this second article is to introduce aspects of quality assurance related to laboratory facilities, laboratory equipment, health and safety, staff training, and improvement opportunities. A brief description of the various topics discussed further in this article should be included in the quality plan, with more detail added within laboratory SOPs (the topic of the third article in the series).
Facilities
The in-clinic laboratory should be in an area of the veterinary practice that provides adequate light, ventilation, electric and water supplies, and space for sample and reagent preparation, analysis, and storage. The laboratory area should be conveniently accessible but not situated in a high-traffic area. The ambient temperature should ideally be controlled in the range of 22°C to 25°C (72°F to 77°F) and humidity in the range of 30% to 50%, given that most instruments are designed to function best within these specified environmental conditions.
Instrumentation
The most common testing performed at in-clinic laboratories includes serologic testing for tick-borne, FeLV, FIV, and heartworm infections; serum or plasma biochemical analysis; hematologic analysis; urinalysis; and fecal analysis. Coagulation testing, blood gas analysis, hormone assays, cytologic evaluation, and microbiological testing (culture and identification of bacteria) are less common.1 Centrifuges (fixed-angle, swinging-bucket, and micro-Hct types), refrigerators, non–frost-free freezers, automated benchtop hematology and biochemistry instruments, and microscopes are among the laboratory equipment required for these analyses. The following considerations should be taken into account when purchasing or leasing inclinic automated instruments2:
Ease of use: Will all relevant veterinary personnel in the practice be able to operate the instrument after basic training? Are instruction manuals easy to follow and accessible? Are maintenance procedures simple to perform?
Footprint: What amount of space is needed for the instrument? How much noise is generated? What are the electricity requirements? How much waste material is generated?
Financial viability: What is the purchase or leasing cost of the instrument and associated contract duration, consumable and reagent requirements, maintenance and quality control requirements, cost of potentially discarding unused expired material, and technician time, as compared with the income generated from running an expected number of samples per time period? How do the results of this cost-benefit analysis compare with the costs and benefits of sending the same samples to a reference laboratory instead?
Appropriateness of the instruments or assay for use in veterinary patients: Has the instrument been tested and found to be accurate and precise for the species for which it will be used?3 Have available reference intervals been generated for the instrument from an appropriate reference population in accordance with relevant guidelines?4 Are results of independent, peer-reviewed studies available to substantiate the manufacturer's claims?
Data management: What format of report is generated? What are the data storage requirements? How can the instrument interface with the clinic information system (medical record)? Does the instrument provide adequate (at least 6 months) and easily retrievable data storage?
Quality control: Does the instrument have a quality control mode whereby individual and cumulative results of quality control measurements can be viewed in a tabular or graphic format?
Availability and nature of technical support from the manufacturer or distributor: Is there a service package? If so, what does it cost and include, and what is the duration of the instrument warranty?
An instrument performance and maintenance log should be available for each piece of equipment in the in-clinic laboratory.3 The maintenance section of the log should include details and check boxes for when routine maintenance procedures (eg, cleaning and changing of parts), annual service, and any software updates are due. The frequency and type of maintenance procedures are usually recommended by the equipment manufacturer, but additional procedures can be added if needed. Any problems experienced with the equipment, as well as details of resolution of each problem, should be recorded in this log. Temperatures of refrigerators and freezers should be recorded daily on a temperature chart, along with actions taken if the temperature strays from the specified range acceptable for the materials or reagents stored therein.
Automated instrument performance is monitored through the analysis of QCM, which is a material used to mimic a patient sample. The results of QCM measurement should be used to calculate instrument accuracy and precision (discussed in more detail in the fourth and fifth articles of this series). The performance log should include at least an indication of whether each QCM run has passed preset goals and what remedial action or actions were taken if QCM analysis failed. The results of each QCM run should be recorded, either automatically via a quality control mode by the instrument itself or entered manually into a spreadsheet. Lot numbers and expiration dates of reagents and QCMs should also be recorded in the maintenance log.
Health and Safety
The veterinary practice environment poses many potential health and safety hazards. Those pertaining to in-clinic laboratories specifically include physical, chemical, and biological hazards. Workplace health and safety regulations may differ from country to country, and employers should be aware of these, but certain aspects apply to all diagnostic laboratory environments.
Physical hazards
Physical hazards particular to in-clinic laboratories may include loud noise from equipment and ergonomic hazards.5 Excessive noise can be produced by instruments and centrifuges, and low noise–generating instruments should be purchased with this in mind. Long periods of microscope use can cause injury to the neck and wrists, and microscope users should try to maintain an erect posture with forearms placed parallel to the floor.6 New microscopes with improved ergonomic designs should be considered. Other examples of laboratory tasks that may be associated with a risk of work-related musculoskeletal disorders include data entry and repetitive pipetting movements.6 Cuts and abrasions from working with glass micro-Hct tubes and slides may also occur.
Chemical hazards
Chemical hazards associated with in-clinic laboratories include disinfectants and chemicals used for sample analysis (eg, instrument reagent packs, stains, and microscope oil). Exposure may occur through inhalation or dermal contact. Information on the risks associated with the use of various chemicals can be found in the safety data sheet that accompanies each chemical substance. These data sheets outline the potential hazards associated with the use and storage of a particular chemical, potential health effects caused by exposure, and first-aid measures to be taken in the event of exposure. Safety data sheets for all chemicals used in the laboratory area should be kept together in a file or folder for quick reference in the event of a problem. A spill kit should be easily accessible in the laboratory area in case of chemical or biological spills. These kits are commercially available and typically include absorbent material, neutralizing agents, protective clothing, disposable bags, and a waste container.
Biological hazards
Sources of zoonotic agents in the laboratory environment include but are not limited to blood, serum, plasma, urine, feces, and tissue samples. Some types of QCMs may be serum or blood based and thus may have the potential to contain infectious agents. Ideally, personal protective equipment consisting of protective outer clothing (eg, lab coat) and gloves should be worn when handling patient samples. Eye protection and a surgical mask may also be used, particularly if aerosol formation is likely,7 such as when cleaning up spills or pipetting. Proper hand hygiene is one of the most important precautions that can be taken to prevent zoonotic disease transmission.8 Needlestick injuries may occur when transferring sample material. Needles should be disposed of into a sharps container as soon as possible. Needle recapping should be avoided where possible, but if recapping is necessary, the 1-handed scoop method should be used (placing the needle cap against a firm vertical surface and pushing the used needle into it with 1 hand, then lifting up the syringe and attached covered needle), with the capped needle removed from the syringe and discarded into a sharps container.8 Sample containers must be labeled clearly and stored in a designated area or refrigerator and packaged in accordance with local regulations if transport is required. Laboratory surface areas should be cleaned and disinfected frequently. If microbial culture and identification are performed in the clinic laboratory, work surfaces should be swabbed and microbial culture of the collected swab specimens performed regularly. All medical waste, including spills, unused sample material, and chemicals from analytic procedures, should be disposed of as required by local regulations.
A practice's health and safety program should apply to the entire clinic environment and include the laboratory section. The approach to formulating the health and safety policy or plan will include identification of risks, instigation of risk prevention and control, training, formulation of health and safety-related policies and SOPs, and maintenance of a reporting system for workplace-related illness and injury.9 More information on developing a practice health and safety plan is available from the US Occupational Health and Safety Administration.10
Staff Training
All staff permitted to work in the laboratory area should receive appropriate training.11 This should encompass pertinent aspects of quality assurance and quality management as well as instruction covering the various sample preparation procedures, analytic processes, and reporting of test results. Training materials should include SOPs and printed or electronic information provided by the manufacturers of benchtop instruments, in addition to other materials needed to achieve competence in the analysis of veterinary specimens.
Competencies of individual staff members can be assessed through ongoing informal evaluations and formal audits. These evaluations could include participation in an external proficiency program, such as that offered by the Veterinary Laboratory Association12 and provided by some commercial laboratories and other organizations13,14,15 or internal evaluations such as comparative blood smear analysis and SOP compliance assessment. One staff member is likely to be allocated to manage or spend most of their time in the laboratory, but all veterinary personnel, including veterinarians and veterinary technicians, should have adequate training and competency if their jobs allow them to perform laboratory tests. The SOPs should include a sign-off sheet to be completed once the SOP has been read. Records should be kept of training and proficiency evaluations and should be signed by a senior staff member. Of note, the Academy of Veterinary Clinical Pathology Technicians offers a program for licensed veterinary technicians to become a veterinary technician specialist in clinical pathology.16
IOFs
As explained in the first article of this series, the final stage of the total quality management system loop is quality improvement.17 Integral to this stage is the identification of problems or errors (nonconformities) affecting the quality of laboratory results. To this end, a formal recording system is needed to identify nonconformities and propose corrective and preventive actions. The use of IOFs is a practical way to address this within the in-clinic laboratory, and this principle can be easily applied to the rest of the clinic environment. An IOF should contain the following fields (Appendix 1; Supplementary Appendix S1, available at: avmajournals.avma.org/doi/suppl/10.2460/javma.258.3.273):
Name of the person submitting the information (eg, staff member or client).
Date or dates of detection of the nonconformity and of IOF submission.
Sample or patient to which the IOF refers, if applicable.
Type of nonconformity, problem, or idea for improvement (example categories: sample material, sample container, analytic phase, QCM, maintenance, supply, or reporting of results).
Description of the nonconformity, problem, or idea for improvement.
Presumed root cause of the nonconformity or problem.
Immediate corrective action that took place to resolve the nonconformity or problem.
Any preventive action that will be implemented to prevent the nonconformity from occurring in the future (usually involves a review and sometimes revision of the relevant SOP or SOPs).
Plans for implementation of improvements, plans for corrective or preventive actions, and plans for ongoing monitoring to determine if the actions have been effective.
Date of discussion of the report.
Completed IOFs should be discussed at regular meetings. The emphasis of these discussions should not be on blaming and shaming staff. Rather, the discussions should focus on the cause and resolution of the nonconformity or problem as related to the total quality management system, policies and procedures, clinic environment, and staff training. The use of a formal recording system to document errors and subsequent corrective and preventive actions has been shown to decrease error frequency in the veterinary laboratory environment.18
Clinical Bottom Line
The physical environment of an in-clinic laboratory and the equipment contained therein contribute to the quality of laboratory test results generated within the clinic. Maintenance of all equipment must be kept up-to-date, and maintenance and quality control procedures should be documented. The health and safety of personnel are of paramount importance, and a formal health and safety policy should be in place, with reference to the particular hazards associated with an in-clinic laboratory. Staff should be trained in health and safety principles as well as aspects of laboratory management, and competency should be assessed regularly through both formal and informal assessments. A formal system for documentation of nonconformities, other problems, and ideas for improvement should be in place, with the aim of improving quality through the implementation of corrective and preventive actions. A checklist is provided to aid implementation of these concepts (Appendix 2; Supplementary Appendix S2, available at: avmajournals.avma.org/doi/suppl/10.2460/javma.258.3.273).
Acknowledgments
No third-party funding or support was received in connection with this study or the writing or publication of the manuscript. The authors declare that there were no conflicts of interest.
Abbreviations
| IOF | Improvement opportunity form |
| QCM | Quality control material |
| SOP | Standard operating procedure |
References
- 1. ↑
Bell R, Harr K, Rishniw M, et al. Survey of point-of-care instrumentation, analysis, and quality assurance in veterinary practice. Vet Clin Pathol 2014;43:185–192.
- 2. ↑
Flatland B, Vap LM. Quality management recommendations for automated and manual in-house hematology of domestic animals. Vet Clin North Am Small Anim Pract 2012;42:11–22.
- 3. ↑
Flatland B, Freeman KP, Friedrichs KR, et al. ASVCP quality assurance guidelines: control of general analytical factors in veterinary laboratories. Vet Clin Pathol 2010;39:264–277.
- 4. ↑
Friedrichs KR, Harr KE, Freeman KP, et al. ASVCP reference interval guidelines: determination of de novo reference intervals in veterinary species and other related topics. Vet Clin Pathol 2012;41:441–453.
- 5. ↑
National Institute for Occupational Safety and Health. Veterinary safety and health. Available at: www.cdc.gov/niosh/topics/veterinary/physical.html. Accessed Aug 6, 2020.
- 6. ↑
Occupational Safety and Health Administration. Laboratory safety. Ergonomics for the prevention of musculoskeletal disorders. Available at: www.osha.gov/Publications/laboratory/OSHAfactsheet-laboratory-safety-ergonomics.pdf. Accessed Sep 8, 2020.
- 7. ↑
Wright JG, Jung S, Holman RC, et al. Infection control practices and zoonotic disease risks among veterinarians in the United States. J Am Vet Med Assoc 2008;232:1863–1872.
- 8. ↑
Williams CJ, Scheftel JM, Elchos BL, et al. Compendium of veterinary standard precautions for zoonotic disease prevention in veterinary personnel (Erratum published in J Am Vet Med Assoc 2016;248:171). J Am Vet Med Assoc 2015;247:1252–1277.
- 9. ↑
Gibbins JD, MacMahon K. Workplace safety and health for the veterinary health care team. Vet Clin North Am Small Anim Pract 2015;45:409–426.
- 10. ↑
Occupational Safety and Health Administration. OSHA recommended practices for health and safety programs. Available at: osha.gov/shpguidelines. Accessed Aug 7, 2020.
- 11. ↑
Flatland B, Freeman KP, Vap LM, et al. ASVCP guidelines: quality assurance for point-of-care testing in veterinary medicine. Vet Clin Pathol 2013;42:405–423.
- 12. ↑
Veterinary Laboratory Association. Quality assurance program. Available at: www.vetlabassoc.com/quality-assurance-program. Accessed Sep 11, 2020.
- 13. ↑
Synlab. Veterinary quality assurance scheme. Available at: vet.synlab.co.uk/the-veterinary-pathology-group-launches-their-external-quality-assurance-scheme. Accessed Sep 11, 2020.
- 14. ↑
Idexx. EQA programme for Idexx VetLab analysers. Available at: www.idexx.co.uk/en-gb/veterinary/reference-laboratories/eqa-programme. Accessed Sep 11, 2020.
- 15. ↑
Camus MS, Flatland B, Freeman KP, et al. ASVCP guidelines: external quality assessment and comparative testing for reference and in-clinic laboratories. Vet Clin Pathol 2015;44:477–492.
- 16. ↑
Academy of Veterinary Clinical Pathology Technicians. About us. Available at: www.avcpt.net/about_us. Accessed Aug 7, 2020.
- 17. ↑
Cook JR, Hooijberg EH, Freeman KP. Quality management for in-clinic laboratories. The total quality management system and quality plan. J Am Vet Med Assoc 2021;258:55–61.
- 18. ↑
Hooijberg E, Leidinger E, Freeman KP. An error management system in a veterinary clinical laboratory. J Vet Diagn Invest 2012;24:458–468.
Appendix 1
Example of an IOF for use in in-clinic laboratories.
| IMPROVEMENT OPPORTUNITY FORM | ||
| Document No.: [eg, 2019–2] | Version: 1 | In-Clinic Laboratory [Hospital name and location] File name: [eg, 2019–2 Improvement Opportunity Form.docx] |
| Original release date (if revision): [N/A or date] | Page: 1 of 1 | |
| Created by: | Checked/authorized by: | |
Name of person submitting this information:
______________________________________________
Please circle: STAFF CLIENT OTHER (PLEASE SPECIFY):
_________________________________________________________________________________
Date of submission:
_________________________________________________________________________________
Sample/patient number:
_________________________________________________________________________________
Type of nonconformity (please circle):
| SAMPLE COLLECTION | SAMPLE MATERIAL | SAMPLE REQUEST |
| ANALYTIC | COMPUTER SYSTEM | REPORTING |
| SUPPLY | MAINTENANCE | QUALITY CONTROL |
| DOCUMENTATION | CLIENT | OTHER |
_________________________________________________________________________________
Description of nonconformity, problem, or idea for improvement:
_________________________________________________________________________________
Cause of nonconformity or problem:
_________________________________________________________________________________
Immediate corrective action:
_________________________________________________________________________________
Planned preventive action:
_________________________________________________________________________________
Discussed at Quality Management Meeting on (date):
_________________________________________________________________________________
Further action required (please circle): YES NO
_________________________________________________________________________________
If YES, please state:
Appendix 2
Checklist for facilities, instrumentation, health and safety, training, and improvement opportunities for in-clinic laboratories.
| Recommendation | Compliant? | Additional comments by the auditor |
|---|---|---|
| The in-clinic laboratory is an area with adequate light, ventilation, and electric and water supply and has space for sample and reagent preparation, analysis, and storage. | □ Yes □ No | |
| Ambient temperature is 22°C to 25°C, and humidity is 30% to 50%. | □ Yes □ No | |
| The following are considered when purchasing in-clinic instruments: ease of use, footprint, financial viability, appropriateness of the instruments or assay for use in veterinary patients, data management, and availability of technical support. | □ Yes □ No | |
| An instrument performance and maintenance log is used for each piece of equipment. | □ Yes □ No | |
| Temperatures of refrigerators and freezers are recorded daily on a temperature chart. | □ Yes □ No | |
| The clinic has a health and safety plan that addresses physical, chemical, and biological hazards associated with the clinic's laboratory. | □ Yes □ No | |
| Personnel working in the laboratory have received the necessary training. | □ Yes □ No | |
| Records of training and proficiency evaluations are kept. | □ Yes □ No | |
| IOFs are used to identify nonconformities. | □ Yes □ No | |
| Improvement opportunity or nonconformity reports are regularly discussed, and preventive actions are implemented as appropriate. | □ Yes □ No |
