Whether planning for a new laboratory, or analyzing the appropriateness of your current testing, it is important to do a periodic assessment not only of what you want to offer your ordering physicians, but what you can realistically offer. The laboratory’s test menu should be aligned as closely as possible with physicians’ 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 send out or maintain in-house.

Begin this process by:

1. Reviewing the current or proposed laboratory operation[i]

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 or demand for specific tests? · What is the complexity of testing already performed or planned? (waived vs. non-waived, with attendant regulatory requirements, including personnel) · Can your Laboratory Information System (LIS) handle additional instrumentation, automation and testing capacity? · 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 work space available to accommodate all phases of new patient testing from specimen collection to test result reporting? Additional staff?

The answers to these questions provide guidance for any changes to the test menu, which will be a determinant 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.

2. Performing a Cost / Benefit Analysis[ii]

· Is the present instrument capacity adequate for the current or proposed test menu?

· The cost of new instrumentation (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 (will you need to buy new refrigerators or freezers?)

· Frequency and expense of Quality Controls, Calibration, and Maintenance

· Are 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

· Data storage requirements / LIS capability

· Adjusting the front office staffing to handle additional pre and post analytical paperwork and communications

3. Considering external factors as well[iii]

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, 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.

§ Does your laboratory perform Point of Care Testing (POCT) in distant locations? This may affect decisions on instrumentation and the test menu as well.

§ 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 additional 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, variety of tests offered, operating times and staffing.

4. Recognizing 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[iv].

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. Laboratories have become the central source of information (“Data Central”) for 70% of physician diagnostic decisions

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

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[vi]

Effective laboratory planning requires competent management. It is through the application of management skills that changes can be implemented 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 re-positioning of the laboratory in the community.

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

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

[iii] Strategic Planning For The Clinical laboratory. Martha Robbins and Associates. Clinical laboratory Consulting. https://www.labconsultant.com/strategic.htm [iv]R. Saunders and A. Westerink. Sidebar: The Strategic Value of laboratory Outreach. Nov 1, 2014. https://www.hfma.org/Content.aspx?id=25853

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

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