What do you want from your reference laboratory?

April 1, 2002

By: Kathleen M. LaBeau1, Sharon Granade2 and Steven J. Steindel2

A report card on send-out testing in the Pacific Northwest

Regardless of the size of your laboratory or the sophistication of your on-site testing menu, its likely that you sometimes need to send some laboratory testing out to fulfill the needs of your patients, physicians, or clients. 

In the United States, the bulk of laboratory testing (80 percent) occurs in sites that perform a complex menu of tests, with the remaining tests being conducted in sites with limited menus, primarily those classified as physician office laboratories (POLs).1 When looking at the Clinical Laboratory Improvement Amendments of 1988 (CLIA) database information, the majority of registered sites are POLs (59 percent), but only 7 percent of the total volume of laboratory testing nationwide is performed in POLs. In contrast, hospital and independent laboratories comprise just 10 percent of all CLIA-registered laboratories, yet they perform 69 percent of the total volume of testing in the nation (Hearn, TL, unpublished report, January 1997).

To evaluate trends in referral laboratory testing, we conducted a study to find out how clinical sites choose and use reference laboratories and what problems they encounter with send-out testing.

Pacific Northwest Laboratory Medicine Sentinel Monitoring Network

Since 1995, we have gathered information from the Pacific Northwest Laboratory Medicine Sentinel Monitoring Network to identify factors that influence the accuracy, reliability, and accessibility of laboratory testing in hospital, independent, and POLs. Created through a cooperative agreement between the Washington State Department of Health and the Centers for Disease Control and Prevention, the network comprises 630 clinical laboratory sites performing waived, provider-performed microscopic procedures (PPMPs), moderate- and high-complexity testing in Alaska, Idaho, Oregon, and Washington. The network has provided interest groups (physicians, laboratorians, manufacturers, educators, consumers) and regulators with information on trends in the practice of laboratory medicine. Full-text reports of 18 previous studies can be found at: www.phppo.cdc.gov/mlp/pnlmsmn.asp.

Utilization of referral laboratories by waived and PPMP sites

In February 2001, we mailed a questionnaire to the 264 network participants categorized as waived and PPMP sites. One hundred ninety-one participants returned a completed questionnaire, a 72 percent response rate. Using Census Bureau designations, 74 percent were categorized as urban and 26 percent rural. In addition to POLs, laboratories in the following clinical settings were represented: clinics, nursing homes, pharmacies, hospital ancillary services, home health agencies, rehabilitation centers, health departments, occupational health programs, community health clinics, and student health clinics. We asked the following questions:

Where is send-out testing being done?

Most waived and PPMP laboratories used independent (commercial) laboratories (53 percent) as their primary reference laboratory, and 68 percent of those using independent laboratories sent the work within 25 miles. Those using hospital laboratories as their reference laboratory (28 percent) were even closer, with 92 percent having to send their work only 10 or fewer miles away.

How accessible are reference laboratory testing services?

Overall, 75 percent of our respondents were within 25 miles of their reference laboratory, with only 9 percent having to send work more than 100 miles away. As might be expected, more rural sites had to send testing out at greater distances than urban sites. Forty-one percent of rural laboratories sent work to a referral laboratory located more than 50 miles away. When rural sites used hospital laboratories as their primary reference laboratory, 85 percent sent the work within 10 miles. 

What do clients want from their reference laboratories?

When given a list of factors used in choosing a reference laboratory, the top responses were:

  • Reputation of the laboratory.
  • Turnaround time for test reports.
  • Courier services.
  • Proximity to my facility.
  • On-site computer or printer for test results.

Rural laboratories viewed turnaround times, courier services, and proximity as the most important features, whereas reputation counted first with urban laboratories. A higher percentage of rural laboratories were interested in having problems solved by their reference laboratory than found in urban sites. The selection of a referral laboratory due to a managed care or insurance contract agreement ranked relatively low for all laboratory types, and was even less influential in laboratories in rural settings.

What problems are being encountered with send-out testing?

We found that few respondents (10 percent) had changed their reference laboratory in the previous two years, and even fewer (7 percent) did so because of problems or issues of testing quality. 

When specifically asked to list problems and problematic tests, 38 percent gave a response. The most frequent problems reported were: 

  • Turnaround times for test reports (37 percent). 
  • Compromised specimens (11 percent).
  • Incorrect tests performed (11 percent). 
  • Courier services (10 percent). 

Concerns about test accuracy and quality were relatively low (6 percent). 

A wide variety of tests were recorded.

How do waived and PPMP sites compare with higher complexity laboratories?

In studies conducted in 1996 and 2000, we polled our moderate- and high-complexity network POLs on these same issues. Comparing information gathered from the previous studies with the findings of our current study of waived and PPMP sites allows for some interesting observations. 

Overall, we found that the referral laboratory services desired and the problems encountered with send-out testing were similar for both limited testing sites and laboratories conducting higher complexity testing. We also found that factors involved in choosing and using reference laboratories had generally changed little from 1996 to 2001. 

In our 1996 study we focused on the role that managed care and insurance contract agreements played in determining where testing was sent. In particular, network members feared they would lose access to their chosen referral laboratory if a managed care contract dictated the use of another laboratory. Although most laboratories were exposed directly or indirectly to managed care, we found that few laboratories selected managed care as one of their top factors in determining where referral laboratory work was sent. Laboratories in urban areas experienced the effects of managed care more than those in rural areas; however the number of laboratories affected in either category was low.2 Our current study of waived and PPMP sites shows this same pattern. 

Waived and PPMP sites were generally closer to their referral laboratories and had fewer problems with their send-out testing than the higher complexity POLs we studied. 

Both waived and PPMP sites and moderate- and high-complexity laboratories ranked turnaround times, compromised specimens, and incorrect test performance as top problems with their reference laboratories. Both types of laboratories were also concerned about tests that had to go to their primary reference laboratory first, and then were sent to a second reference laboratory, thus complicating specimen handling and delaying the testing and reporting. Waived and PPMP laboratories also found courier services troublesome, while the higher complexity laboratories were more concerned with the accuracy and availability of the referral laboratorys information to properly order and submit tests. In some cases the test names are confusing [e.g., Human Immunodeficiency Virus (HIV): qualitative, quantitative, viral load, genotype; Hepatitis: panel, profile, B surface antigen, B surface antibody, B core antibody, C RNA, Polymerase Chain Reaction (PCR)-quantitative]. Clients are unsure what test to order and what results they will receive back. In other cases, the written instructions given to clients for ordering testing are confusing, outdated, or are in conflict with instructions received by telephone.

Relatively few of the limited testing sites or the more complex testing sites changed their reference laboratories due to problems, but a higher percentage of moderate- and high- complexity laboratories reported problematic tests than did waived and PPMP sites. Both groups included esoteric tests, PAP smears, cultures, hepatitis, and HIV testing as their most problematic tests.

Reference laboratories, take note!

In the Pacific Northwest, the report card for reference laboratory services appears to be generally favorable. Few laboratories have changed reference laboratories due to problems, and concerns about testing quality or accuracy are low. 

For urban laboratories, access to referral testing services appears to be good. Most sites using independent laboratories are relatively close to their reference laboratory; those using hospital laboratories are even closer. While rural laboratories cannot do much about their location, choosing a community hospital for their referral work may improve access. Otherwise, rural sites have special needs for courier services and on-site printers for result delivery. 

The list of customer demands is long, and challenges clearly exist for reference laboratories to satisfy this potential client base. Turnaround times drive the selection of a referral laboratory and generate the most concerns by reference laboratory clients. Consumers also want frequent and reliable courier services, current and correct information for test selection and specimen submission, and reports delivered on-line. 

But even when these needs are met, customers will also look for competitive pricing, well designed requisitions and reports, a phlebotomist stationed on-site, and error-free bills. Reference laboratories have their work cut out for them.

Kathleen M. LaBeau is on the staff of the Office of Laboratory Quality Assurance, Washington State Department of Health, Seattle, WA.
Sharon Granade and Steven J. Steindel are members of the staff of the Division of Laboratory Systems, Public Health Practice Program Office, Centers for Disease Control and Prevention, Atlanta, GA.

References

1. Steindel SJ, Rauch WJ, Simon MK, Handsfield J. National Inventory of Clinical Laboratory Testing Services (NICLTS): Development and Test Distribution for 1996. Arch Pathol Lab Med 2000;124:1201-1208.

2. LaBeau KM, Simon M, Steindel SJ. Access to Laboratory Testing: The Impact of Managed Care in the Pacific Northwest. Clin Lab Manage Rev 1999;13:137-142.

© 2002 Nelson Publishing, Inc. All rights reserved.

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