Streamlining Institutional Pathway Processes: The Development and Implementation of a Pathology Molecular Consult to Facilitate Convenient and Efficient Ordering, Fulfillment, and Reporting for Tissue Molecular Tests

Most laboratory test orders can be placed electronically without the need for providers to consult laboratory personnel. This is the case because the majority of laboratory testing is performed on specimens received by the laboratory after the order is placed. Receipt of the specimen triggers the laboratory to review the orders and execute the required tests. Molecular diagnostic tests are frequently ordered on specimens collected at a previous point in time. Since orders on such specimens are unaccompanied by a new specimen to initiate order fulfillment, the process of placing the order, by itself, does not trigger test performance. Since these specimens already reached the laboratory, the process of placing the order, by itself, does not trigger the laboratory to begin since no new specimen is received. Some manner of communication is required to initiate the process. Further, most of these specimens are irreplaceable; therefore, they must be handled with the utmost care to ensure optimal tissue utilization.

One safeguard is the mandatory retention of tissue for years in the form of formalin-fixed paraffin-embedded tissue blocks. Because of sample irreplaceability, requests must be reviewed for appropriateness, then the tissue retrieved from storage and reviewed for sufficiency prior to the order being executed.

Determining appropriateness often necessitates exchange of information between ordering providers and pathologists. The need for back-and-forth communication and review of tissue by an anatomic pathologist for orders on anatomic pathology specimens precludes the automation seen with most clinical pathology orders. This inexpediency remains a source of frustration for ordering providers even though they understand the process.

To complicate matters, the lack of standardization introduces frank inefficiency. No electronic medical record system (EMRS) currently has a standard function specifically designed or optimally suited to allow for the simultaneous placement and bidirectional communication necessary for such orders. Therefore, an order for molecular testing on anatomic pathology tissue must be accompanied by a separate communication between oncology and pathology. Because of the lack of a standard process, various methods of communication are used to accomplish these requests. At the authors’ facilities, methods included: alphanumeric pages, telephone calls, voicemails, emails, Microsoft Teams messages, in-person requests in passing or during a tumor board meeting, and EMRS alerts. Furthermore, these multiple oncology providers used these methods to communicate with numerous pathologists. Without a predetermined point of contact, oncology providers would need to figure out which pathologist to contact. This created additional work for oncology providers and necessitated that all pathologists continuously monitored all communications methods. Without standardized documentation of this communication, oncology providers were often unaware of communications made by other providers. This resulted in redundant work by oncology and pathology.

At one medical center, the oncologists asked the pathologists to examine developing a process by which oncologists could request anatomic pathology tests and communicate the necessary information for such orders within their EMRS. With the help of information technology and information management experts, it was decided that a consult would best serve this purpose. Unlike orders, consults allow for the creation of associated notes that can be added at any time in the future and by people other than the ordering provider. The working group at that medical center drafted a template consult form through a series of calls and meetings. After implementation at their medical center, they worked with a similar group at another medical center to refine the consult and ensure generalizability to other facilities.

The consult form was designed to apply to any type of anatomic pathology testing. It could be used to request something as simple as an immunohistochemical stain (eg, PD-L1), as complex as a series of specific fluorescence in situ hybridization (FISH) probes and genes, or as exhaustive as comprehensive genomic profiling (CGP) (Figure 1).

The goal was to develop a way for the oncology provider to request molecular tests on archived specimens in the EMRS without needing additional communications with pathology outside the EMRS to get request fulfillment or status updates and that would reliably report in a designated location in the EMRS (Figure 2). Consider, for example, an oncology provider needing CGP performed on prostate cancer tissue. Said provider simply places the pathology molecular consult (PMC), or even delegates completion of the PMC to someone qualified to do so, and in most cases this alone will result in the test getting performed, an alert when results become available, and a link directly to the report. Placement of the PMC simultaneously sends electronic alerts to all stakeholders and provides a place where everyone can communicate to collectively complete the request in the most efficient way.  Among others, this includes the ordering provider, designees in charge of completing vendor requisitions, personnel tasked with physical retrieval of archival glass slides and paraffin blocks, and pathologists who review the request and select tissue to be tested.

As it was intended to maximize efficiency, information that may formerly have prompted back-and-forth questions was provided on the form for oncologists. For example, when a CGP assay is selected, the provider is provided with the list of accepted indications at that facility and asked to provide an explanation if the test does not meet indications (Figure 3).

This is not to prevent requests in cases where testing is still desired, but instead to prevent another call where the pathologist would have to ensure that the order was not placed in error or that another assay may not be more felicitous. For example, when PD-L1 is requested alongside a CGP assay, the ordering provider is asked whether PD-L1 testing can be delayed until the CGP results if the CGP assay includes tumor mutational burden (TMB) assessment and the PD-L1 request does not meet one of our institutional indications (Figure 4). The next generation sequencing (NGS) assay used by our facility includes PD-L1 when institutional indications for PD-L1 testing are met. Since TMB ≥10 mutations/megabase can qualify a patient for immunotherapy, it can obviate PD-L1 testing, which in cases not meeting indication could be billed to the patient’s insurance. 

Such nuanced details are more likely to be consistently addressed in a templated communication like that of a consult than they are in extemporaneous conversation and illustrate the necessity of such communication in approximating ideal personalized care.

Information that pathologists may need that is not readily available to them is asked of ordering providers. For example, when PD-L1 testing is ordered, the pathologist has a number of assays to choose from depending on the tumor type and specific immunotherapeutic agent. A companion diagnostic assay is approved by the US Food and Drug Administration (FDA) for one or more specific tumor types and drugs. Prices and insurance coverage vary between assays. By using reliable laboratory developed tests (LDTs) for tumor types or drugs other than those for which the FDA-approved assays are indicated, providers can avoid potentially higher out-of-pocket expenses for the patient.. Such savings cannot be realized if the pathologist is unaware of which specific drug is going to be used.

Much of anatomic pathology testing is performed at reference laboratories. Because these reference laboratories usually lack access to the ordering institution EMRSs, they are increasingly turning to online portals to report results. The older method of faxing or mailing results can require the company to regenerate and resend the report if a copy is misplaced or an additional copy is requested at any point in the future. Since ordering institutions are already using the portals, testing companies are also transitioning from paper requisitions to portal ordering. It is certainly more efficient for the person completing the order form since information can be autopopulated from previous orders, but the overall efficiency is reduced by requiring people from both oncology and pathology to access the portal if all information asked for on the form is not readily available for independent completion by either oncology or pathology. In our consult form, beside such tests we list the less accessible pieces of information asked for on requisitions so that when tests requiring such information are requested pathology can complete the consult without oncology needing to enter the portal and duplicate work (Figure 5).

Ordering tests on anatomic pathology specimens is one problem but reporting the results of them is a whole other problem. Results of molecular tests are usually needed by multiple providers, at least some of whom lack portal access and to whom results were not sent. Many institutions do not have standard procedures for ensuring that reference lab results are consistently incorporated into the patient’s medical record. Further, due to the length and complexity of molecular diagnostic reports, they often cannot be fully incorporated into the laboratory package of the EMRS and may need to be stored as a scanned document. If the patient transfers care, such scanned results may not be available to outside providers since the institution where the test was ordered may not include scanned documents when sending medical records to outside providers.

The consult provides a standard process for reporting anatomic pathology test results that allows for incorporation into the patient’s medical record in a way that the result, or at least knowledge of its existence, will follow the patient should he or she transfer care at any point in the future.  At our facilities, we instituted a standard procedure whereby a designated person is given access to all portals, downloads all portal results, sends the downloaded files to the health information management service with notation as to where to link and how to name the file in the medical record, and reports the presence and location of the files in the consult note.

By virtue of creating notes, consults allow for documentation in ways that orders cannot. In the EMRS, a note is created when a consult is placed. The note documents all the information inputted by the ordering provider when placing the consult. At any point after the creation of the consult, notes can be added to this initial note. We use this ability to provide status updates throughout this process that can be quite protracted and which would usually result in multiple status queries. Notes with timestamps and electronic signatures are added to document that the consult has been received, that slides and blocks are being retrieved from storage, that particular tissue blocks contain or lack sufficient tissue for testing, that particular slides or blocks were sent for testing, when and where results can be found, as well as summaries and interpretations of results (Figure 6).

Since the implementation of the consult, more than 1000 tests of various types have been ordered using the consult. Involved oncology and pathology personnel from both facilities have reported improved satisfaction with anatomic pathology test ordering and reporting due to the efficacy, convenience, and efficiency of the consult. Ordering providers have appreciated the ability to place anatomic pathology test requests in the EMRS while placing other orders, being apprised of status throughout the process, and the reliability and ease of finding results. Pathology has appreciated the decreased time spent fielding duplicate requests, vetting inappropriate requests, having pathologist time occupied doing work that could be done by clerical staff or histotechnologists, and independently providing the same information to multiple people. While the process will not be identical at other institutions, it is our hope that this report of our process and experience will inspire and guide similar solutions at other institutions. 

Authors: Daniel Mettman, MD¹; Michael Goodman, MD²; Joseph Modzelewski, MD²; Linda Verkruyse, MD¹; Susie Willis²; Janet Barrett¹; Robert Hoyt, MD³; Maryam Abdo, MBChB³; Hanan Elsarraj, MD, PhD³; Sharad Mathur, MD¹

Affiliations: ¹Kansas City Veterans Affairs Medical Center, Kansas City, MO ²Salisbury Veterans Affairs Medical Center, Salisbury, NC ³University of Kansas Medical Center, Kansas City, KS

Disclosures: The authors have no disclosures to report.

Address correspondence to:

Daniel Mettman, MD
4801 Linwood Boulevard Mail Stop 113
Kansas City, MO 64128
Phone:+1 (816) 861-4700
Email: daniel.mettman@va.gov