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Daniel M. Baer, M.D., Richard E. Belsey, M.D.

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Preview

This chapter will discuss selection of a referral laboratory, how to get the best service from your referral laboratory, and how to decide whether to send a test to a referral laboratory or to do it in your office laboratory.

• Educational Objectives for the Referral Laboratory Section
• Referral Laboratory Selection
  • Exercise
  • Commentary
• Getting the Best Service from Your Referral Laboratory
• Should We Test It, or Send It Out?
  • Exercise
  • Commentary
• Suggested Reading

Educational Objectives for the Referral Laboratory Section

Daniel M. Baer, M.D., Richard E. Belsey, M.D.

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Upon completion of this section, the reader should be able to:

1. List the factors for selecting a referral laboratory
2. Use a checklist for rating perspective referral laboratories
3. Describe items that can add to costs of sending tests to a referral laboratory
4. Establish a good working relationship with your referral laboratory
5. Provide the necessary information when submitting a test request to the referral laboratory
6. Describe why you must use the correct specimen tube or container when submitting a specimen
7. List the factors for deciding whether to test in the office or send to a referral laboratory
8. List costs involved in office laboratory testing

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Referral Laboratory Selection

Daniel M. Baer, M.D., Richard E. Belsey, M.D.

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Your in-office laboratory will probably meet only part all of your diagnostic and management testing needs. It will therefore be necessary to find a referral laboratory to handle the balance of your testing needs. In this section we will examine how to select a referral laboratory.

The selection process involves two basic steps: 1) defining the service, quality and consultative support needed from a referral laboratory; 2) Evaluating each prospective referral laboratory's ability to meet these requirements. Factors that are important in the selection of a laboratory include the following:

• Tests offered
• How specimens are handled and whether assistance is provided in obtaining and handling them
• Turn around time
• Adequacy and style of reports
• Availability and quality of consultation services
• Licensing and accreditation
• Cost
• Extra services offered
• Professional and business reputation
• Quality and adequacy of personnel
• Quality management activities

Download and print out one or more copies of the checklist for use in the following exercise. The one shown presents a scoring scheme for comparing referral laboratories. The replies to each question have been assigned points. You should give highest consideration to the laboratory receiving the greatest number of points, but because you may place a higher or lower value on some of the factors, a laboratory receiving a lower score may be more suitable. Some factors are so important that despite a high score, a laboratory lacking one of these may be eliminated from consideration. For example, a laboratory with a poor reputation for its business ethics might be eliminated from your consideration despite a relatively good score in other factors.

Exercise

You and your laboratory staff can evaluate several referral laboratories by doing this exercise and than reading the commentary that follows. The checklist can be helpful in recording and organizing the data you obtain from the prospective referral laboratories.

1. Make a list of the tests you are likely to want to refer to an outside laboratory. Compare your list with the list offered by the prospective referral laboratory.
2. Inquire about the referral laboratory's specimen and handling.
3. Ask to see some sample reports from each prospective referral laboratory. Some laboratory reports are more readable and informative than others. You may have a preference of type of format. How are reports returned to your office? by messenger, mail, printing terminal, internet or telephone?
4. What does each laboratory state as its turn-around-time?
5. Does the laboratory have a pathologist or other doctoral level scientist available for consultation?
6. Inquire about licensing and accreditation.
7. Review the charges that the laboratory will make to your patients and ask if there are any charges to your laboratory for providing pick-up and reporting of results.
8. Do HMOs that your patients use allow you to use this laboratory?
9. Inquire about any educational service, consultation, or interpretative manuals the laboratory might provide. Also check whether it has a designated customer service representative to serve you. How do they keep you informed of new or updated services?
10. Does the laboratory have a reputation for high quality and integrity? Be sure to ask for references.

Commentary

1. The referral laboratory's list of tests should include all of the tests you need. If it does not, the laboratory may be able to forward the specimen to a laboratory that offers the test.
2. The laboratory should provide a manual containing instructions for specimen. The manual should include clear instructions for specimen collection including:
   • Patient preparation
   • Type of tube or anticoagulant to be used
   • Special instructions for preservation and shipping of specimens
   • Lists of interfering drugs or foods
   • Quantity of sample required
   • Special handling instructions, such as centrifugation or freezing prior to shipping
   • Reference intervals (normal values) for the tests and if possible some interpretative comments.

     There are other potentially important differences between referral laboratories that might be important when you compare them:

   • Some laboratories provide specimen containers, mailers and request forms
   • Does the laboratory pickup specimens from your office?
   • Is the pickup and delivery schedule convenient?
   • Is there a delay of more than two hours between the pickup time and delivery to the laboratory? If so, are the specimens refrigerated while in transit?
   • Does the laboratory require that blood samples be spun to provide serum or plasma, or does the laboratory accept whole blood specimens?
   • Many laboratories provide containers with special preservative for tests where sample deterioration may occur (eg lead-free blood tube for blood lead test or urine tube with preservative for microscopic examination).
3. Do you like the format for reports? Look at several examples including, chemistry, hematology, coagulation and microbiology.
   • Is it difficult to find the test result, the reference range, the time and date the sample was obtained, the patient's name, the referring physician's name?
   • Do results of tests such as protein electrophoresis include interpretations?
   • Does the laboratory's manual contain reference intervals, test methods and interpretative information?
   • Is the laboratory's method for returning test results returned to your office convenient for you and at a time that fits your office routine? If your office's business with the referral laboratories large, they might be willing to install a printing terminal in your office at no charge.
   • Are significantly abnormal results reported to you by telephone? Can you obtain from the laboratory a list of test values that would prompt a telephone report? Are test values outside of the normal (reference) range highlighted on the report?
4. From the physician's perspective, turn-around-time is the length of time between obtaining the specimen from the patient until the report is evaluated by the physician and a diagnostic or therapeutic decision is made. Although the referral laboratory may quote an expected turn-around-time, in practice, it is necessary for you to estimate it for your practice, keeping in mind that probable times patients will be seen in the office, pick-up times by the referral lab, times of delivery of completed reports, and the time the physician is in the office, ready to evaluate the test report.
5. You may wish to be able to consult a laboratory professional about appropriateness of tests and the interpretation of results. Some referral laboratories will provide advice and assistance to your office laboratory, helping you choose tests and test methods and assisting with trouble-shooting and quality control. From time to time laboratories produce reports that are inconsistent with the patients condition. The referral laboratory's response if you report such a situation will be revealing. Are they defensive? Do they offer to retest the sample you have submitted or ask for a new sample for testing? Do they indicate that it will be done without charge to the patient? Do they question you about interfering drugs or foods that may have caused the inconsistent result? Can you establish a relationship with a specific laboratory professional, or do you talk to a anonymous voice when you call for advice? What are the client service hours? Remember that the laboratory may be located in a different time zone and that their hours of availability may be different from your office's hours of operation.
6. All laboratories are required to be licensed under Clinical Laboratory Improvement Act of 1988 (CLIA '88). Ask the laboratory representative if the laboratory has been restricted from doing any tests because of poor performance in proficiency testing. If the laboratory refers some tests to other laboratories, ask if the performance of those laboratories in proficiency tests is periodically reviewed. Ask if they are accredited by the College of American Pathologists (CAP) or Joint Commission on Accreditation of Healthcare Organizations (JCAHO). If the referral laboratory forwards some tests to another lab, does it restrict such referrals to laboratories that are accredited?
7. Referral laboratories vary in their charges to patients. It is frequently possible to reduce the cost to patients by ordering high volume test panels instead of individual tests. Review the referral laboratory's price schedule and discuss options with the service representative. Also inquire whether there are overhead costs to your office, such as postage or shipping costs, provi-sion of sample containers, supplies, such as collection tubes or needles. Do they charge you for the cost of a terminal for receiving printed reports? Do they charge for consultation services?
8. HMOs frequently negotiate favorable prices with specific laboratories. Patient laboratory benefits are then restricted to the use of those labs. To avoid dealing with multiple referral laboratories, it is an advantage for the physician with HMO patients to use the HMO's contract laboratory
   

   Occasionally, however, the service or quality of the HMO's contract laboratory is not acceptable. A strategy to use in such situations is:

   1. Notify the appropriate responsible person at the HMO, in writing, of the unsatisfactory service, giving specifics.
   2. Follow up with a phone call to the responsible person at the HMO.
   3. Contact other physicians who have the HMO's patients and inquire whether they also have similar problems with the contract laboratory.
   4. Ask them to document the problems and to notify the HMO about them.
   5. Ask these physicians to contact their physician peers and widen the circle of physicians contacting the HMO about the laboratory performance problems.
      

   When multiple physicians are perceived as having a problem with a laboratory, the HMO is more likely to take the matter seriously than if it appears to be an isolated problem.

9. Some laboratories are well known for providing excellent educational services such as frequently revised manuals and newsletters for you and your office staff, or training in specimen collection and handling. Will they provide advice for your office laboratory? Is there a customer service representative who can interact with your office staff and handle service problems?
   
   CLIA '88 requires that laboratories without technically qualified staff have a technical consultant to provide guidance in evaluation of available test systems, develop procedures that will provide information which is comparable to the high quality produced in other laboratories in the community and develop quality assurance protocols to insure the accuracy and precision of the reported results. These consultative services may be available through the referral laboratory.
10. A laboratory that has operated under its present leadership in your area for a number of years and is used by many of your professional colleagues, is likely to provide good and reliable service.

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Getting the Best Service From Your Referral Laboratory

Daniel M. Baer, M.D., Richard E. Belsey, M.D.

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Defining Your Expectations

A physician's office laboratory will have good service from its referral laboratory if both agree on reasonable expectations, and strive to meet them. Issues that must be agreed on include:

• Turn-Around-Time (TAT): Usually, the referral laboratory's Users' Manual indicates the schedule for performing tests, and the expected turnaround time. If this is not the case, try to have the laboratory define the expected turnaround time for tests you commonly send them. This should be defined in relation to their schedule for picking up specimens from your office and their delivery of test reports. To get a better turnaround time, you may need to adjust the time you obtain specimens from patients, or negotiate a different time for pick-up of specimens.
• Users' manual: Referral laboratories usually provide a users' manual to their clients; The manual's quality and usefulness can vary. At a minimum, the manual should list:
  • Specimen requirements, including type of collection container, amount of specimen, and any special handling instructions such as protection from light, removal of blood cells from serum or refrigeration or freezing;
  • Tests available from the lab, the analytical method and their reference ranges;
  • Usual turn-around-time and testing schedule;
  • Cost to the patient;
  • Whom to call if there is a question or problem.
• Request forms: Some request forms are easier to use than others. Referral laboratories that are extensively computerized can sometimes design a custom form that lists the most commonly ordered tests for the practice, and includes the office's name and account number to aid the staff in preparing the form. Physicians should be familiar with the test names on the form. By ordering tests using those names, they can assist their office staff and avoid errors in ordering. A good request form might even give specimen collection information. Some laboratories are beginning to provide for ordering over the internet. If you find your referral laboratory's request form confusing or hard to use, discuss the problem with the laboratory's customer service representative. Bringing the problem to the laboratory's attention may improve service for other users as well.
• Billing: Most referral laboratories bill the patient directly. In some states, this is required by law. Be sure you understand the laboratory's required information for billing. In some situations, such as for Medicare billing, clinical information must correlate with the test in order for the laboratory to be paid.
• Problem resolution: The Customer Service Representative is the first line of problem resolution. Your staff should become acquainted with this person and know how to reach him or her. Should a problem arise that can not be solved to your satisfaction by the Customer Service Representative, you may need to speak to the laboratory's Medical Director.

Getting Good Service

Use the request form properly

Be sure your staff completes all requested information on the form. Complete patient information, identification of your office, and the correct test name are essential. Be sure to print clearly. If you want a test that is not listed on the request form, consult the referral laboratory's users' manual. If it is listed, the test should be ordered using the exact name in the manual. If the test is not listed, it is best to call the laboratory and inquire about the test or about using an alternative test to elicit the information needed.

Sometimes the request form asks for clinical data in addition to the required diagnosis. At times, this information is vital in interpreting the results. Some information is essential to provide, such as the fasting status of a patient tested for plasma glucose, or use of a medication prior to collection of a sample during the course of a stimulation test. Clinical information is especially important in interpretation of endocrine tests.

Attention to detail in filling out the referral laboratory's test request form is important. Correctly identifying the patient is especially important if more than on member of the family is seen in your office. An error could result in the wrong family member being given a test result. Many laboratories require that in addition to the patient's name, a second unique piece of patient identification should be given on the requisition and specimen label. This might be the patient's social security number or birth date.

Age and sex should be shown on the request form so the referral laboratory can indicate the correct age and sex specific reference values for comparison with your patient's test results. In some cases, the patient's diagnosis is requested. It may be necessary for the referral laboratory to have this information in order to collect reimbursement from an insurance carrier.

Reporting

The referral laboratory's report forms should be easy to read, and contain appropriate reference ranges. If you have difficulty reading test results, discuss this with the Customer Service Representative or Laboratory Director. A different report format may be possible, especially if the report is computer-generated. Report delivery over the internet to the physician and sometimes to the patient is possible from some laboratories.

Developing a Relationship

Service will be perceived as more personal if you and your staff are able to establish a closer relationship with members of the referral laboratory's staff. Large laboratories may have a customer service representative who functions as a sales person, trouble shooter and as a local contact for the laboratory. Frequently, this person will have a professional medical laboratory technology background, and can work with your staff to teach them how to use the referral laboratory optimally. If there are service problems, this individual is the first line of problem resolution.

Many referral laboratories' Users' Manual do not have a clear statement on how to resolve problems or whom to call for problems. If this is the case with your referral lab, contact the laboratory's customer service representative and get this information. Usually, the customer service representative is the first person to call if there are service problems. The name and phone number should be written into the Users' Manual so it's handy when a problem arises.

Professional Consultation

Consultation is usually available from a doctoral level professional at the referral laboratory. Most referral laboratories are more than happy to advise their users about test selection, result interpretation for specific patients, test interferences due to food, drugs or other factors, and to provide specific protocols for performing complex tests such as endocrine stimulation tests.

Specimen Collection and Handling

These are critical steps in the testing process. Carefully follow the referral laboratory's instructions about the correct collection tube or container to use. Compulsive attention to anticoagulants and preservatives is essential for correct test results. Substituting a different kind of tube may result in a specimen that is unsuitable for testing. For example, heparin anticoagulant (green top tube) is not suitable for coagulation tests, while the citrate tube (blue top tube) is required. If the blue top tube is not completely filled, however, the proportion of citrate to plasma will be wrong, and an erroneous test result will be produced. Be sure that if your office laboratory procedure manual has instructions for collection of specimens for the referral lab, the instructions are up to date in regard to specimen tube requirements. If your laboratory's procedure manual does not have these instructions, the staff should refer to the referral laboratory's instructions each time a specimen is collected. Refrigeration, freezing or protection of the specimen from light must be done if indicated in the users' manual.

Communication

Make your expectations known to the customer service representative or laboratory director. The Referral Laboratory Selection Checklist in this chapter can form the basis for discussion of your expectation.

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Should We Test It, Or Send It Out?

Daniel M. Baer, M.D., Richard E. Belsey, M.D.

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Now we will focus on the decision making process used to decide whether to perform a test in the office or send it to a referral laboratory. Like all other patient management decisions, this decision should be made in an informed, thoroughly thought out and organized way. Factors that affect this decision include:

• Medical and logistical needs for rapid test reporting.
• Requirements of CLIA '88 that your laboratory will need to meet in order to do the test.
• How many specimens your laboratory will test each time testing is done, and how frequently the test will be performed.

Exercise

Select a test that is currently performed in your office laboratory, or which you are considering to perform in the office laboratory. Download and print a copy of the worksheet and answer its questions for your laboratory.

Commentary

Medical Needs

The major reason for performing tests in the office laboratory rather than sending them to a referral laboratory is that the results may be needed during the patient's visit, in order to quickly diagnose a problem and initiate or revise therapy. Additionally, follow-up may be more difficult once the patient has left the office. Tests for proteinuria are an essential part of a prenatal visit. Tests for bacteriuria can allow early therapy in a patient suspected of cystitis. A serum theophylline concentration might be helpful in adjusting therapy in patients who appear to be having an inadequate therapeutic effect from the drug. Blood A1c hemoglobin can be used to monitor diabetes control in the previous several weeks. Tests whose results do not lead to a medical decision at the time of the visit are more likely to be sent to a referral laboratory.

Technical Factors

A test should only be done in an office laboratory if it can be done accurately. The ability to provide reliable test results is limited by the availability of test methods and equipment that your staff is competent to use, and the time to perform the test. Can your staff perform this test or must you train or recruit someone with the necessary skills? What level of professional supervision will the office staff require to perform the test and will that supervision be available at all times when the testing is needed? How easy is the test to perform? If the test requires the full attention of the technician, will this interfere with the office routine? Does the test procedure make the technician unavailable to assist you for a prolonged period of time? Ideally it would be desirable for the test to be simple enough to be run by an alternative staff member if the technician is ill or on vacation. One way to gauge the level of difficulty of a test and method is to consider its classification under the CLIA '88 complexity model. If the test is classified as highly complex, it is probably best to send it to a professionally operated referral laboratory.

Whether the specimen can be transported to another laboratory without deterioration in transit is another factor in determining where to test. Specimens for sedimentation rate must be tested within 16 to 24 hours after being drawn as must tests for prothrombin time. Moreover, the specimen must be refrigerated. If there is no other laboratory facility in town, it may be necessary for you to perform these tests in your own laboratory, or to make arrangements for the patient to travel to a town where the test can be done.

Before deciding to do additional testing in your laboratory you should carefully consider whether an alternative test might provide the same information. Hemoglobin or hematocrit may provide adequate information and avoids the necessity of doing a red cell count. Several methods exist for testing urine specific gravity: urinometers, refractometers, and reagent sticks.

The availability of equipment is also a consideration. Each chemical analyzer on the market has a menu of available tests. Try to choose the system with the menu that best suits your needs. If you are adding a test and already have a test system, is it capable of doing the additional test? Another factor relating to test equipment is the availability of service and technical trouble shooting for any new system you are considering.

Another technical consideration is the anticipated workload. This can affect your decision in a number of ways. It is necessary to perform tests and procedures fairly frequently to retain proficiency. All reagents have a finite life expectancy. Your workload should be high enough to be able to use all of the reagents in the kit prior to their expiration dates. Tests that have such a low workload as to not use up the reagents prior to their expiration should be candidates for referral laboratory testing.

Legal Considerations

Tests that are classified as highly complex under the CLIA '88 complexity model require a more qualified staff than other tests. Before considering performing such tests, be sure that the laboratory will meet all regulatory requirements for CLIA '88 and your state (if the state has any).

Some tests carry a higher exposure to medical malpractice risk than others. For instance, blood typing and neonatal bilirubin tests have been featured in a number of malpractice suits involving laboratories. Carefully review any tests that could expose your laboratory to a higher level of risk and be sure that the laboratory staff is properly qualified to perform such testing.

Financial Considerations

Production of income is not generally the primary motivating factor in deciding whether to perform laboratory tests in the office, but financial factors must certainly be considered. The daily volume of each test has a direct influence on the cost. Cost per test must include the cost of reagents for standardization and quality control, wastage of reagents due to out-dating, the costs of standards and controls required as part of the daily quality control program, proficiency testing costs, amortization of equipment, and the cost of personnel and space for the laboratory. Because many of these are fixed costs unrelated to the volume of tests, they can be a significant factor when the volume of testing is low. In considering whether to add a new test, consider whether additional equipment will be necessary for the test and whether there is adequate space. Will you have to provide training for your technician? Will there be a charge for this training and will a replacement be necessary while this person is in training?

Although in many states the patient must be charged directly by the laboratory performing a test, you should consider the cost of the test if performed by an independent laboratory, your laboratory's cost for performing the test, the price which you can charge for the test done in your own laboratory, and third party reimbursement policies and fee schedules. In some states, for instance, third party payers will only pay an amount equal to the lowest charge for the test from an independent laboratory regardless of whether the costs for testing in your office are higher than the reimbursement.

Managerial Considerations

For tests of moderate complexity, (link to CLIA Test Categorization web site http://www.CMS.hhs.gov/CLIA your laboratory will require the services of a technical consultant who will assist in the choosing of methods and test systems, set up quality control for the test, review and evaluate proficiency test results, and troubleshoot problems. The consultant should be able to advise you about the appropriateness of performing a test in your laboratory or sending it to a referral laboratory.

Tests classified as highly complex by CLIA '88 require a supervisory technologist with in-depth understanding of the tests and the ability to independently troubleshoot problems with them.

Physician and Patient Convenience

Immediate return of results allays anxiety in both physician and patient. With certain patient populations, there are significant benefits in having the results available quickly. Patients who are elderly or infirm, or live at such a distance from the physician's office that a return visit or a special trip to the pharmacy is inconvenient and impractical will benefit from rapid testing in the office. The physician and patient can avoid the time and expense of an additional visit; follow-up phone calls to the patient or pharmacy may not be necessary.

Testing in the office laboratory has been shown to improve office efficiency. It has been estimated that the additional effort of retrieving a medical chart, reviewing it once test results have been returned from the referral laboratory, contacting the patient and/or pharmacy, making an appropriate chart note and refiling the chart requires about 14 minutes of staff time. This additional work is eliminated if the test results are available while the patient is still in the office

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Suggested Reading

Daniel M. Baer, M.D., Richard E. Belsey, M.D.

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1. Baer DM, Good R and Orr J. A Quality Approach to Referral Lab Contracting. Medical Laboratory Observer, July 1997. pp 62-67.
   This paper discusses how a consortium of hospital laboratories rated and set up a contract with referral laboratories, using a rating form similar to the one used in this chapter.
2. Nelson JC, Using Referral Labs Efficiently. Medical Laboratory Observer, June, July, August 1991.
   Dr. Nelson discusses the decision to send work to a reference laboratory vs doing the work in your lab, how to evaluate and monitor the quality of work done by the reference lab, and how to get the best service from a reference laboratory.
3. National Committee for Clinical Laboratory Standards, Selecting and Evaluating a Referral Laboratory. NCCLS Document GP9-A, Wayne Pa. www.nccls.org
   This document was written as a guide to laboratories offering reference services as well as those using them. It is intended as a standard for the laboratory industry, setting expectations for good service.
4. Shaw, ST, "Selection of Reference Laboratory Services," Clinics in Laboratory Medicine 1983;3:509-523.
   This article was written primarily for the clinical laboratory community. It focuses on selection criteria for a reference laboratory and the writing of an RFP (request for proposal).

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