Wednesday, February 09, 2022

By Irwin Z. Rothenberg, MBA, MS, CLS(ASCP), Technical Writer /Quality Advisor, COLA Resources, Inc. 

Introduction

Whether planning a new, start-up laboratory operation, or performing an analysis of current testing, (providing input for decisions on whether or not to purchase new or replacement instruments, or add or delete tests), it is important to do a realistic assessment not only of what you want to offer, but what you can realistically offer. The laboratory’s test menu should be aligned as closely as possible with physician expectations and needs, as well as the laboratory’s operational capabilities. 

By strengthening relationships with ordering physicians, laboratories can more accurately forecast future service needs and make the best decisions as to test menu, instrumentation, and staffing, including which tests to outsource or maintain in-house^[i].

Begin this process by:

 Reviewing Basic Information about the Current / Proposed Laboratory Operation

The first step in the planning process for adding new tests and new instrumentation begins with asking the following baseline questions regarding the present or proposed laboratory operation:

• What is your present test menu? Present instrumentation? Present staffing levels?
• What medical specialties are represented by your ordering physicians? (an important determinant of what tests will be requested, as well as patient demographics)
• Do you anticipate changes in the number of client physicians served? New specialties added? New populations served?
• What are your current or anticipated test volumes / demand for specific tests?
• What is the complexity of testing already performed or planned? (waived vs. non-waived, with attendant regulatory requirements, including personnel)
• What are your present hours of operation with attendant staffing levels / type and volume of testing performed per shift / commitment for turn-around times?
• What are your anticipated operating and capital budgets? (important determinant for changes to instrumentation and level of automation; as well as staffing expertise)
• Is adequate workspace available to accommodate all phases of new patient testing from specimen collection to test result reporting?

The answers to these questions provide guidance for any changes to the test menu, which will be a driver for decisions on whether to acquire new or replacement instruments.

The next step forward is to perform a Cost/Benefit analysis of your present operation, and of the proposed changes to the test systems to determine economic and logistical feasibility.

Determine the Feasibility of Adding New Tests:

Perform a Cost / Benefit Analysis[ii]

It is by taking into account the internal as well as external factors in the laboratory environment, that the decisions made will have the best chance of success.

Below are items to consider for your cost/benefit analysis:

• Instrument capacity for current or proposed test menu (is it “right-sized” for test volume and level of staffing)
• 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 for reagents (do you need to buy a new refrigerator or freezer?)
• Frequency and expense of Quality Controls, Calibration, and Maintenance
• Tests run singly or in batch-mode
• Comparison of in-house testing with reference laboratory charges and turn-around time
• Complexity of present and proposed testing.
• Staffing requirements: number, training expenses; qualifications and experience beyond present staffing; continuing education
• Proficiency Testing requirements
• Facility space, ventilation, electrical needs; hazardous disposal requirements
• Time and involvement of the Lab Director, and the Technical Consultant
• Document storage requirements / LIS capability
• Adjusting the front office staffing to handle additional pre and post analytical paperwork and communications

Additional strategies to determine the appropriateness of testing offered, and the instrumentation needed[iii].

• Analyze test mix and outsource demanded but low-volume tests. Only outsource these tests if you can provide the test results a lower cost and with a better turnaround time.
• Project test demand and costs to determine which tests to perform in house. Conversely, analysis of send-out volumes may indicate opportunities to bring certain tests in-house.
• Partner with reference laboratories. Reference laboratories can provide valuable support in the form of financial analysis, methodology assessment, and provision of clinical samples to help make in-source-versus-outsource decisions and to establish and increase on-site test volumes.

Consider external factors as well[iv]

Consider what is going on in the laboratory industry today, noting trends both locally and across the country and seeing if these factors may affect your laboratory:

•  What will be the impact of changes in reimbursement / payment mechanisms?

• What is the current market for your laboratory services? Estimating market size and location is a critical component to determine market opportunity. These estimates will drive financial outcomes.
• If you are part of an organization that has adopted the concept of value-based medical care, and it now part of an Accountable Care Organization (ACO), or accepts “bundled payments”, your expenses will come under increased pressure to be held down and minimized. You may be encouraged to outsource more than originally planned.
• The well-documented staffing shortage may be a factor in your area; consider your local situation if planning to increase testing, add shifts, and new pre-analytic services.

Of course, providing the highest level of service for your patients may justify costs associated with the above considerations, but it is vital to ensure that your instrumentation can handle the changes in projected demand in terms of test volume capacity, variety of tests offered, operating times and staffing.  This may require considering more automation. Automation has long been regarded as an important means for clinical laboratories to achieve greater operational efficiency, test accuracy, method standardization, total data handling and reduced turnaround time; in short, an improved quality of patient care.

The development of new generations of automated stand-alone and bench top equipment has made automation a more viable option for labs of all sizes—and in many cases, a necessary option for labs seeking to remain competitive in today’s marketplace[v]. 

Steps in Determining the Right Automation for Your Laboratory[vi]

1. Questions to ask when deciding how much automation is needed

The amount of automation needed depends on the type and size of your laboratory. If all you are looking for is increased throughput and you don’t really have to deal with diverse assays and readouts, then you might want to think about modular components. So, with a few nonintegrated pieces of equipment, you can get the throughput you need without a huge investment, or additional space required.

1. Set priorities for automation based on realistic budget limitations

Once you have taken care of the above, and determined your needs, start getting quotes on systems needed.   Budget negotiations will begin, with sets of reality checks on what is doable and what is not.   Decisions should be based on priorities set in advance.

1. A few more points to remember

Always choose a vendor who can provide prompt, affordable service to minimize any downtime. Remember  the data management involved. There are different sets of tools for data processing, data mining and data visualization, and you need to think about how you are going to track and analyze this data. Finally, create an infrastructure that can be easily modified or expanded for other applications.

1. Plan for downtime for routine maintenance and equipment breakdown
2. Consider purchasing a service contract[vii]

A service contract can include many services beyond a general warranty, such as software updates, calibration, certification, preventative maintenance, priority service, and/or additional discounts on upgrades. Service contracts can be costly, and you can either discuss options with colleagues or make your own informed decision. Several reasons why you may choose to purchase a service contract could include reduced hassles if your equipment breaks, faster/priority repairs and a predictable expense in your budget. If a piece of equipment is critical to your work, you use it frequently, and major repairs are very expensive, a service contract may be worthwhile. In terms of budget, you will know exactly what you are going to pay in advance and will not be blindsided with a major "surprise" expense.

Recognize the strategic importance of physician / laboratory relationships

One of the ways that laboratories can use their resources more effectively is to strengthen their relationships with physicians. These relationships are vital as strategic assets, and, as the demands on physicians continue to multiply, they will increasingly rely on their laboratory partners for diagnostic support.  Physicians increasingly seek a diagnostic resource that can meet all of their testing needs[viii].

Laboratories are discovering that they are well positioned to provide medical guidance and direction for clinicians who are trying to maneuver their way through the increasingly complex world of laboratory testing. 

To efficiently manage laboratory test utilization requires both ensuring adequate utilization of needed tests in some patients and discouraging superfluous tests in other patients[ix].

An important step in this process is to work with client physicians on a program of proper test utilization to encourage the most efficient and relevant use of the testing offered. 

 The key role of competent management in accomplishing these goals[x]

Effective laboratory planning requires competent management. It is through the application of management skills that you can implement change with minimal disruption.

Competent laboratory management includes effective communication with the staff; providing key information and direction for the continuing future development of the laboratory; and encouraging involvement in the development of strategic plans.

Successful management can motivate staff to provide feedback about their workload; instruments and kits used; make suggestions for improvement of, and changes to, their test menu; and provide information about interactions with other offices, departments, physicians, and patients.  These types of information play an important role when developing strategies for cost containment, automation, growth, re-alignment, and even repositioning of the lab in the community.  

[i]R. Saunders and A. Westerink. Sidebar: The Strategic Value  of laboratory Outreach. Nov 1, 2014.  http://www.hfma.org/Content.aspx?id=25853 

[ii] The Cost Effective Laboratory: The Changing Landscape of Laboratory Testing. Laboratory Testing Matters. August 2015.   http://www.labtestingmatters.org/the-cost-effective-laboratory-the-changing-landscape-of-laboratory-testing/

[iii] R. Saunders and A. Westerink. Sidebar: The Strategic Value  of laboratory Outreach. Nov 1, 2014.  http://www.hfma.org/Content.aspx?id=25853

[iv] Strategic Planning For The Clinical laboratory. Martha Robbins and Associates. Clinical laboratory Consulting.

 http://www.labconsultant.com/strategic.htm

[v] G Tufel   Right-Sizing Laboratory Automation. Clinical Lab Products. December  17, 2014.   http://www.clpmag.com/2014/12/right-sizing-laboratory-automation/

[vi] M. Ferrer. Ask the Expert: How to Automate Your Lab to Best Fit Your Needs. Lab Manager. January 2011.

http://www.labmanager.com/ask-the-expert/2011/01/ask-the-expert-how-to-automate-your-lab-to-best-fit-your-needs

[vii] K Huey. Starting a New Lab:  How to Develop a Budget and Buy Equipment.  American Physiological Society (APS).

http://www.the-aps.org/mm/Careers/Mentor/Managing-a-Lab-and-Personnel/Early-Career-Professionals/Setting-Up-a-Laboratory/Developing-a-Budget-and-Buying-Equipment

[viii]R. Saunders and A. Westerink. Sidebar: The Strategic Value  of laboratory Outreach. Nov 1, 2014.  http://www.hfma.org/Content.aspx?id=25853

[ix] Dr. Curtis Hanson and Elizabeth Plumhoff.  MAYO CLINIC: Test Utilization and the Clinical Laboratory.  May 2012. http://www.mayomedicallaboratories.com/articles/communique/2012/05.html

[x] How To become A Good Lab Manager by Elizabeth Sandquist.  ASBMB Today. October 2013.