Context.—On-line clinical laboratory manuals are a valuable resource for medical professionals. To our knowledge, no recommendations currently exist for their content or design.

Objective.—To analyze publicly accessible on-line clinical laboratory manuals and to propose guidelines for their content.

Design.—We conducted an Internet search for clinical laboratory manuals written in English with individual test listings. Four individual test listings in each manual were evaluated for 16 data elements, including sample requirements, test methodology, units of measure, reference range, and critical values. Web sites were also evaluated for supplementary information and search functions.

Results.—We identified 48 on-line laboratory manuals, including 24 academic or community hospital laboratories and 24 commercial or reference laboratories. All manuals had search engines and/or test indices. No single manual contained all 16 data elements evaluated. An average of 8.9 (56%) elements were present (range, 4–14). Basic sample requirements (specimen and volume needed) were the elements most commonly present (98% of manuals). The frequency of the remaining data elements varied from 10% to 90%.

Conclusions.—On-line clinical laboratory manuals originate from both hospital and commercial laboratories. While most manuals were user-friendly and contained adequate specimen-collection information, other important elements, such as reference ranges, were frequently absent. To ensure that clinical laboratory manuals are of maximal utility, we propose the following 13 data elements be included in individual test listings: test name, synonyms, test description, test methodology, sample requirements, volume requirements, collection guidelines, transport guidelines, units of measure, reference range, critical values, test availability, and date of latest revision.

Laboratory medicine is a broad and complex discipline, involving the measurement of hundreds of different analytes using many different techniques and instruments. Laboratories have long recognized the need to provide easily accessible collections of information regarding the testing that they offer.1 This information typically has been published as hardcopy clinical laboratory manuals.2 These paper manuals have proven to be a valuable resource for medical and laboratory professionals.3 However, their use has been hampered by practical issues, including cost, limited space in order to keep the manual small enough to be easily used and printed, the long time between revisions,4 inadequate distribution, and the inherent limitations of physical items, such as loss or damage. The move toward centralized testing facilities, on-line order entry, and networked laboratory information systems necessitates easily accessible and up-to-date testing information for both hospital-based and commercial clinical laboratory facilities. To this end, on-line laboratory manuals, which are typically Web-based, have begun to complement, and even replace, traditional printed versions. This evolution allows for more frequent content updates, increased information about the laboratory and individual tests to be included, and greater accessibility.5–7 The College of American Pathologists Laboratory Accreditation Program mandates that each laboratory create and distribute a specimen collection manual.8 However, the program limits its attention to data elements required for proper collection and transportation of samples. While each on-line manual should be designed to meet the requirements of each laboratory's specific circumstances, a generalized consensus on the data elements that should be present for each test would enhance their utility as a clinical reference. This study aimed to evaluate publicly accessible on-line clinical laboratory manuals and to propose guidelines for their content.

We conducted an Internet search for publicly accessible clinical laboratory manuals written in English with individual test listings. Our goal was to find on-line laboratory manuals from each of the following laboratory subtypes: academic/teaching institutions, commercial/reference laboratories, and community hospitals. Searching was done by a combination of Internet search engines, such as google.com, and also targeted manual searching of Web sites that were considered likely to host a publicly accessible laboratory manual (eg, labcorp.com). Laboratory manuals that were clearly intended to be used only for research purposes and manuals that were produced by institutions not providing clinical laboratory services for human patients were excluded. We did not include sites targeted only at the general public, such as labtestsonline.org. In addition, manuals that were clearly identified as being incomplete or “under construction” were excluded.

Each laboratory manual Web site was analyzed for 5 general features, including the ability to perform a text search for specific tests, presence of an alphabetic list or index of available tests, a listing of the laboratory's accreditations, contact information for the laboratory, and basic-specimen collection information and guidelines (eg, how to obtain a sputum sample). In addition, 4 specific tests (serum sodium, glycated hemoglobin, prolactin, and human immunodeficiency virus [HIV] antibody) in each manual were evaluated for the presence of individual data elements. Sodium was chosen because it is a commonly ordered test, and therefore most laboratories should have an assay to measure sodium. In addition, it is a test that commonly has critical values, that is, levels above and below which the laboratory may contact the ordering provider so that a potentially life-threatening value may be acted on in a timely fashion. Glycated hemoglobin was chosen because there are a variety of synonyms for this test, such as hemoglobin A1c and HbA1c. Prolactin was selected to represent a less common assay and one for which additional clinical and analytic information might be present in the laboratory manual (eg, reasons for ordering this test or an explanation of macroprolactinemia). Lastly, HIV antibody was chosen since there are a number of ethical, logistic, and patient confidentiality issues associated with this test (eg, specific HIV consent forms may need to be signed by the patient prior to performing this test). As such, the HIV antibody entry was anticipated to have additional information and possibly links to other Web pages regarding ordering and result interpretation.

The 4 specific test listings selected were each evaluated for the presence of the following 16 data elements: test description, synonyms, test methodology, sample type, specimen volume requirements, collection guidelines, transport guidelines, units of measure, reference range (including age and sex differences), critical values, test availability or turnaround time, interpretative information (including literature references), hyperlinks to additional information, Current Procedural Terminology codes, contact information for the individual test, and the date that the specific test information was last updated. Each of these 16 data elements was scored as present or absent in the laboratory manual according to the following criteria. Most data elements were scored as present if at least 3 of the 4 specific test listings for each laboratory manual included them. However, the synonym category was scored as present if there were any synonyms listed for “glycated hemoglobin” (HbA1c, A1c, etc), since we felt that this was the only test of the 4 that was likely to have synonyms listed. Also, listings for sodium were used to score critical values, as the other tests were deemed unlikely to have critical values defined. Web links or literature references were scored as present if they were present in any specific test listing. Any additional or unique features specific to the various manuals were also recorded. Analysis of the data elements in each laboratory manual was performed using Microsoft Excel (Microsoft Corporation, Redmond, Wash).

We identified 48 publicly available on-line clinical laboratory manuals written in English, of which 24 originated from hospital-based laboratories (21 were academic institutions and 3 were community hospitals) and 24 from commercial or reference laboratories that appear to provide primarily outpatient testing services to a wide variety of hospitals and clinics. Forty-two (88%) of the 48 manuals were from institutions located in the United States. Two were from Canadian institutions, 3 from Australia or New Zealand, and 1 from Hong Kong. Our analysis of general features (Table 1) revealed that 36 (75%) of the 48 manuals had functional search engines, and 41 (85%) had an alphabetic listing of available tests. Forty-seven (98%) included contact information, 28 (58%) provided general specimen-collection information, and 26 (54%) indicated their accreditations.

Table 1.

General Features Available in On-Line Clinical Laboratory Manuals

General Features Available in On-Line Clinical Laboratory Manuals
General Features Available in On-Line Clinical Laboratory Manuals

All 48 manuals had listings for the 4 tests we specifically targeted for evaluation and were suitable for inclusion in our study. Analysis of the specific test listings (Table 2) showed that no single laboratory manual contained all 16 data elements that we evaluated. A mean of 8.9 (56%) data elements per manual was present (range, 4–14). There was only a minimal difference in the number of data elements present when the laboratory manuals were divided according to the type of laboratory. Among the 24 academic or community hospital laboratories found, the average number of data elements present was 9.2, and among the 24 commercial or reference laboratories, the average number was 8.5. The 2 data elements related to sample requirements (type of specimen and volume required) were the most common, with 47 (98%) manuals containing them. The turnaround times for specific tests were present in 43 manuals (90%), while almost 80% of manuals provided reference ranges, units of measure, or test name synonyms. Data elements with particularly low representation included critical values for sodium (18 manuals [38%]), links to related information (15 manuals [31%]), an explanation or medical significance of a specific test or analyte (9 manuals [19%]), and the date the Web page was last updated (14 manuals [29%]). The frequency of the remaining data elements varied from 10% to 65%.

Table 2.

Presence of Data Elements in Individual Test Listings

Presence of Data Elements in Individual Test Listings
Presence of Data Elements in Individual Test Listings

Finally, several notable features were found in individual laboratory manuals, including sample-collection information with supporting images or graphics, color photographs of sample collection tubes, sample rejection criteria, information regarding the effect of physiologic states (eg, pregnancy) on reference ranges of various analytes, printable HIV consent forms, and downloadable Adobe portable document format (PDF) and Palm personal digital assistant (PDA) versions of the laboratory manual.

We identified 48 laboratory manuals that met our criteria for inclusion in the study, including the laboratory manual at our own institution. We suspect that there are many more on-line laboratory manuals that were not available to us owing to restrictions on outside access or to our choice of search phrases and search engines. However, we believe that our sample was sufficient for our purposes. About half of the on-line clinical laboratory manuals originated from laboratories affiliated with academic medical institutions.

All except 1 of the manuals listed information necessary for adequate specimen collection. However, interpretive and educational information about the tests offered was not a prominent feature of most Web sites. Specifically, data elements of potential medical importance, such as appropriate reference ranges and critical values (for sodium), were found to be absent in several manuals. Educational data elements, including Web links to additional information or resources and literature references were absent in the majority of manuals. The lack of such important data elements in the manuals we evaluated may be related to these manuals being designed for use prior to or during sample collection, and not as a clinical resource that might help health care providers understand or interpret test results or select additional appropriate tests. While sample collection is obviously an important function of a laboratory manual, we believe that information supporting test selection and result interpretation is equally important. This is likely to become more pertinent with the increasing use of Web-based order entry and laboratory result reporting, both of which offer additional entry points into the laboratory manual. Fewer than half of the manuals provided hyperlinks to additional information in the individual test listings. One of the great strengths of the World Wide Web format is that voluminous supporting information can be made available simply by creating hyperlinks. While laboratories may not have the resources or desire to generate their own supporting material, many reliable sources of medical information are currently available on the Internet. The use of appropriate hyperlinks would allow the main test listing to remain brief and uncluttered, and in our opinion, provides a means for interested parties to further their understanding.

The inclusion of supporting information in a manual brings up an important design consideration. Laboratory information systems (LISs) contain much of the relevant test information, such as units, reference ranges, and synonyms for ordering. However, most of these systems do not have the capability of storing, formatting, and displaying all of the various data elements required for a complete on-line laboratory manual. Ideally, an on-line laboratory manual should draw whatever information is possible from the LIS in real time, so that a secondary database will not need to be created and kept synchronized. Multiple laboratory manuals have been implemented using this design strategy of drawing information directly from the LIS6 and other networked resources.7 Recently, an extensible markup language (XML) syntax for clinical laboratory procedure manuals was proposed,9 which, in addition to test method details, includes information relevant to physicians and patients, and might prove useful in implementing laboratory manuals designed for health care providers outside the laboratory.

In 2000, we implemented a Web-based on-line laboratory manual at our institution (http://home.caregroup.org/departments/pathology/). The design was guided by our desire to make each test listing brief, yet still provide sufficient information for clinicians to guide their test selection, sample collection, and test result interpretation. We use a homegrown LIS that has no provision for storing the information needed for a laboratory manual, nor for real-time links to the data tables containing test information. As a result, we designed and implemented a Microsoft SQL Server database to serve as a repository of this information. We have entries for approximately 500 tests in our database. We then created a Web site that pulls the test-specific information from the database using active server pages. A large number of static Web pages were also created, which contain general information about the laboratory, methods of specimen collection (ranging from venipuncture to eye cultures), and expanded information regarding specific tests. This format has served us well and provides the flexibility to continually and easily tailor the content and format to meet our needs. However, it does have the drawback of having to maintain some test information (eg, units and reference ranges) in 2 places—the LIS and the laboratory manual database.

Two other design elements merit discussion. First, we decided to formulate all of the content of our manual in-house. Another option would have been to engage a commercial vendor, such as Lexi-Comp (Hudson, Ohio). For many years, this company provided a service to create customized hardcopy and electronic laboratory manuals that were based on the information in their Laboratory Test Handbook Concise.10 Although Lexi-Comp no longer actively pursues custom laboratory database projects, our understanding is that they may still accept a few new laboratories for such development work. The second consideration is whether the resulting laboratory manual will be freely accessible via the Internet or restricted in some way (eg, password protected or limited to local intranet users). Since many of our laboratory clients are located off-site and may not have easy access to our intranet, having our laboratory manual freely available on the Internet made sense for our situation. When making a decision about access, laboratories will need to consider their local circumstances, including whether a secure intranet infrastructure is already in place and available to all of their users.

Currently, health care providers at our institution use a secure, Web-based, on-line provider order entry system to enter almost all orders on inpatients, including laboratory tests, radiologic examination, and pharmaceutical orders. When selecting laboratory tests, the providers at our medical center have the ability to click on the name of a desired test in order to open a new browser window, which then displays the relevant test listing from our on-line laboratory manual. This ability to link to our laboratory manual gives us an opportunity to provide clinically relevant information, such as expected turnaround time for a given test, at a point in the patient's care when it may be particularly helpful to the clinician. Moreover, within our secure Web-based inquiry system for health care providers, individual result names are again linked to their corresponding listing in the laboratory manual. Thus, our clinicians are able to access specific test information on-line, which includes a contact person, at their convenience, 24 hours a day. Our institution also has a secure on-line system designed for patients to use, which displays different types of information drawn from their electronic medical record, including laboratory test results. As mentioned, our laboratory manual is available on the Internet, but since our test-specific information is designed for use by health care providers, we have not created links from our patient-based system into our laboratory manual. However, we do provide links to another Web site designed to educate the public regarding laboratory testing. For laboratories with the resources and desire to customize their information for use by patients, systems such as this might represent another venue in which to provide accurate and informative information regarding laboratory testing.

Our study indicates that the majority of publicly available on-line clinical laboratory manuals are useful for obtaining information needed for the collection, transportation, and analysis of patient samples in a given laboratory. However, their potential value as a reference and educational resource for medical and laboratory professionals in selecting or interpreting laboratory tests requires the inclusion of more comprehensive and standardized information.

To be useful to health care providers, general features of a clinical laboratory manual should include an alphabetic listing of tests and a search engine to facilitate finding individual test listings, as well as basic specimen collection and transportation information pertinent to that laboratory. The core of any laboratory manual is the individual test listings, and for these listings we propose that the following 13 data elements (Table 3) be included, as a minimum, for each test: test name, synonyms, test description, test methodology, sample type, specimen volume requirements, specimen collection guidelines, transportation information, units of measure, reference range, critical values (if established), test availability or turnaround time, and the date this information was last revised.

Table 3.

Minimum Recommended Data Elements for Individual Test Listings

Minimum Recommended Data Elements for Individual Test Listings
Minimum Recommended Data Elements for Individual Test Listings

Additional information that can be profitably included in the test listings includes hyperlinks to further educational material, literature references, expanded explanations of the medical significance of test results, sample rejection criteria, potential sources of interference, Current Procedural Terminology codes, and relative cost information. While the addition of these or other elements may enhance a clinical laboratory manual, they may also increase the length of each entry. To keep the manual user friendly, we recommend that the individual test listings remain brief and that hyperlinks be used if extensive supporting information is provided.

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Presented as an electronic poster at the Advancing Pathology Informatics, Imaging, and the Internet (APIII 2002) conference, Pittsburgh, Pa, October 2–4, 2002.

The authors have no relevant financial interest in the products or companies described in this article.

Author notes

Reprints: Bruce Beckwith, MD, Department of Pathology, Beth Israel Deaconess Medical Center, 330 Brookline Ave, Boston, MA 02215 ([email protected])