When we discuss the characteristics of a quality laboratory, we naturally look at those areas of the laboratory operation encompassed by CLIA/ AO requirements, including Personnel training and Competency Assessment , Organization, Instrument Verification, Quality Assessment, Record Keeping and Documentation, Proficiency Testing, Facility safety, and so on.
However, one area that is often overlooked when assessing factors that contribute to quality laboratory work is the appropriateness and “do-ability” of the test menu. In fact, this is really such a fundamental aspect of the lab operation, that problems in this area affect everything else.
Whether you are planning a new, start-up lab operation, or performing a cost/benefit analysis of current testing, or thinking of purchasing a new or replacement instrument, you must do a realistic assessment of not only what you want to offer your patients, but what you can realistically offer your patients.
When your instrumentation/test menu creates problems with staffing, time management; work overload, and expiration of unused reagents; when quality control, calibration and maintenance requirements exceed test time for infrequently utilized instruments….you’ve got problems!
Your decision making should first include a cost/benefit analysis:
• Instrument cost (purchase or lease?)
• Reagent cost (are you obligated to purchase reagents from a particular manufacturer?)
• Reagent life (expiration dates: days, weeks, months before/after opening packages)
• Storage requirements (buying a new refrigerator or freezer?)
• Calibration, Maintenance frequency.
• Tests run singly or in batch mode?
• Comparison to Reference laboratory charges and turn-around time
• Staffing requirements: number, training expenses; qualifications and experience beyond present staffing; continuing education.
• Proficiency Testing
• Facility space, ventilation, electrical needs; hazardous disposal requirements
• Time and involvement of the Lab Director, and the Technical Consultant
• Document storage requirements / LIS capacity
• Adjusting the front office staffing to handle additional pre and post analytical paperwork and communications.
Of course, providing the highest level of service for your patients may justify costs associated with the above considerations, but you must right –size the instrumentation to meet the demand in terms of test volume capacity, variety of tests offered, operating times and staffing. Having a laboratory with excess capacity and operating requirements can ultimately bankrupt a practice. Investigate what instruments can meet your present needs, and for the near future, and be cost effective.
In today’s world, when compensation for laboratory testing is constantly under pressure, right-sizing your lab means better financial health; better resource utilization, and ultimately, better service for your patients. This spells Quality!