Disruption of outpatient laboratory services by routing the samples to commercial reference laboratories may seem like a cost-saving measure by the payers, but results in hidden costs in quality and resources to support this paradigm.
To identify differences when outpatient tests are performed at the Children's Healthcare of Atlanta (Children's) Hospital lab compared to a commercial reference lab, and the financial costs to support the reference laboratory testing.
Outpatient testing was sent to 3 different laboratories specified by the payer. Orders were placed in the Children's electronic health record, blood samples were drawn by the Children's phlebotomists, samples were sent to the testing laboratory, and results appeared in the electronic health record. Data comparing the time to result, cancelled samples, and cost to sustain the system of ordering and reporting were drawn from multiple sources, both electronic and manual.
The median time from phlebotomy to result was 0.7 hours for testing at the Children's lab and 20.72 hours for the commercial lab. The median time from result posting to caregiver acknowledgment was 5.4 hours for the Children's lab and 18 hours for the commercial lab. The commercial lab cancelled 2.7% of the tests; the Children's lab cancelled 0.8%. The financial cost to support online ordering and reporting for testing performed at commercial labs was approximately $640,000 per year.
Tangible monetary costs, plus intangible costs related to delayed results, occur when the laboratory testing system is disrupted.
“Care delivery has become increasingly fragmented, leading to coordination and communication challenges for patients and clinicians,” according to the Institute of Medicine.1 The publication recognizes the increasing complexity of care, need for documentation, and sheer amount of data in the current medical practice, resulting in diminishing time for direct patient care. In addition, the complexity of data management translates to time lost to the caregiver, and the possibility of clinically significant results not being communicated in a timely manner. Casalino et al2 found that there was no evidence of transmission of clinically important test results in an adult outpatient clinic for 7.1% of tests, including results such as a cholesterol level of 318 mg/dL, a hemoglobin A1c level of 18.9%, and a potassium level of 2.6 mEq/L. Given the sheer volume of testing, the Institute of Medicine calls for streamlined systems to assist the caregivers in being informed of the results, interpreting them appropriately, determining a course of therapy, and relating this to the patient.3
The systems approach to medicine is heralded as necessary to providing quality patient care. The Centers for Disease Control and Prevention (CDC) identified the importance of the clinical laboratory in the system of care for the patient, noting that, “The contributions of laboratory tests and services as an essential component and partner in health systems remain under-recognized.”4 However, fragmentation of laboratory testing often exists in outpatient medicine because of insurance-mandated routing of laboratory tests to commercial laboratories, and this has the potential to be particularly impactful in pediatric subspecialty medicine.
Children's Healthcare of Atlanta (Children's) located in Atlanta, Georgia, is a multisite children's health care system in which subspecialty outpatient testing is routed to different locations on the basis of insurance agreements. The variability of laboratory testing location allowed for analysis of its impact. The purpose of this article is to compare the impact of laboratory testing performed at an off-site commercial reference laboratory versus the hospital-based Children's Hospital laboratory, and to identify the costs to the Children's system to support testing performed at commercial laboratories.
MATERIALS AND METHODS
The Institutional Review Board at Children's Healthcare of Atlanta approved this study. Laboratory and clinical data for patients seen in Children's outpatient facilities were retrieved from the electronic health record (EHR; Epic, Madison, Wisconsin) from April 1, 2015, through March 31, 2016.
Children's provides phlebotomy services at 14 outpatient locations throughout the system, and phlebotomy at each of these locations is performed for all patients regardless of the testing laboratory. The patient's insurance determines the laboratory that performs the testing, with Children's testing samples from patients with Medicaid or managed Medicaid, and samples from patients with managed care sent to 1 of 2 commercial reference laboratories for testing, based on the insurance plan.
Orders are placed in the Children's EHR, and the test orders are routed to the testing laboratory assigned to the patient's primary insurance via automated rules in the EHR. Orders are sent to the testing laboratory via real-time HL7 orders interfaced directly between the EHR and the laboratory information system (LIS) of the testing laboratory. Following phlebotomy, Children's personnel process samples either at the location of the phlebotomy or at the hospital laboratory for all 3 laboratories. A courier hired by the laboratory where the samples are tested picks up samples from the site after processing is completed. When samples are received, the testing laboratory electronically acknowledges receipt of the samples into its LIS. Results of tests from the Children's laboratory and the commercial laboratories are reported in the EHR at Children's via direct real-time HL7 results interfaces from either the Children's LIS (Sunquest, Tucson, Arizona) or the reference laboratory LIS directly to the Children's EHR.
To minimize variability in workflow surrounding specimen collection, handling, and reporting, data for the interlaboratory comparison were restricted to a single, large pediatric subspecialty clinic adjacent to one of the hospital laboratories. Patients are seen at one of several subspecialty clinics within the building, and the health care is provided to all patients in the same manner, regardless of insurance. The phlebotomists in the clinic building are hired by the Children's laboratory. Approximately 95% of the laboratory tests are collected at this subspecialty clinic. Commercial laboratory draw stations external to the clinic collect a small portion of the tests.
Although samples are sent to 2 commercial laboratories for testing, data from Children's and only 1 of the reference laboratories could be used for this analysis. Children's and the reference laboratory used for comparison had a similar method for posting results to the EHR via HL7, but the other reference laboratory used a different (snapshot mode) method of reporting results via HL7, which resulted in inaccurate electronic capture of turnaround times, so it was excluded from the analysis.
The subspecialties with the greatest amount of laboratory testing were included in this study, and these clinics include rheumatology, gastroenterology, endocrinology, pulmonary medicine, allergy and immunology, and infectious disease.
Data for 6 tests were gathered electronically from the Children's EHR via its Clarity database (Epic), and from Sunquest LIS. The tests chosen for analysis represent the top 80% of plasma or serum tests for the commercial laboratories. These were the comprehensive metabolic profile, complete blood count (CBC), renal function panel, lipid profile, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP). Data related to the preanalytic and postanalytic aspects of testing were gathered for ESR and CRP, and also for specific analytes representing a component of the above panels: aspartate aminotransferase, white blood cell count, phosphate, and low density lipoprotein.
The total number of laboratory tests per encounter was defined as the number of tests ordered at a single event during which a physician/provider places orders. The EHR was used to document each of the time points below, including the time of phlebotomy, receipt in the laboratory, and acknowledgment by the caregiver. Time from phlebotomy to receipt in laboratory was defined as the difference in date and time between sample collection and receipt of the specimen by the laboratory. Time from phlebotomy to result was defined as the difference in date and time between sample collection and result available in the Children's EHR. Time from result to acknowledgment by caregiver was defined as the minimum (earliest) positive difference in date and time between test results being present in the Children's EHR and documentation of the caregiver's viewing of the results. Wilcoxon rank sum tests were performed to compare median response times between laboratories. Descriptive statistics included counts, medians and interquartile ranges, calculated by using SAS v. 9.4 (Cary, North Carolina).
Cost Analysis for System to Support Testing at Commercial Reference Laboratories
The cost of supporting test orders and results between the Children's EHR and the LISs of each of the testing laboratories was analyzed, and included all 14 phlebotomy locations. The effort to support testing for both commercial reference laboratories is included. The methods of data gathering are listed in Table 1, and all data collection was categorized by its impact on the following parts of Lundberg's brain-to-brain model of the diagnostic process: pre-preanalytic, preanalytic, and postanalytic.3,5
To the extent possible, data regarding time and personnel to support the commercial laboratory testing were drawn from project management reports, direct assessment of workflow, and documentation of meetings. The information technology department uses project management software to manage projects and assess time spent on projects, and data from this software were used to estimate the time spent building the interface. The pathologists who were involved in bringing the interface live were asked to estimate the number of days spent on this work, which involved specific day-long meetings to map tests. The time for a phlebotomy draw was assessed by direct observation of approximately 30 episodes of phlebotomy by the manager, who had been trained in Lean principles and workflow analysis. The manager observed multiple phlebotomists for several days to get an average time spent per phlebotomy experience. The amount of time required for management to troubleshoot issues was taken from compilation of the number of issues during the course of a month, with estimates of time to resolve issues provided by phlebotomy supervisors and the outpatient manager. This was annualized. The number of phlebotomy experiences for the commercial laboratories was derived in different ways depending on the location of the phlebotomy: These include reports of the numbers of samples from the commercial laboratories, or hand counting of the number of requisitions requiring phlebotomy for a 6-month period, and annualizing the data. Some of the data are more subjective and consist of estimates of time spent on given tasks by direct interviews of the persons performing those tasks.
The estimated cost for the time involved was taken from the average hourly earnings published by the Bureau of Labor Statistics for 2016, and 20% of these earnings were added to each salary to account for benefits distributed. The hourly wages were calculated as follows: physician, $118.60; technologist, medical and clinical laboratory, $36.02; manager, medical and health service, $63.10; phlebotomist, $19.46; computer systems analyst, $52.86.6
From April 1, 2015, through March 31, 2016, a total of 14,498 patient encounters occurred at the subspecialty outpatient clinic. Ninety-eight percent of the encounters resulted in a laboratory test ordered. Each of these encounters with laboratory tests resulted in an average of 2.63 laboratory tests.
Of the 14,342 tests included in the study, 8577 (60%) were sent to the Children's laboratory and 5765 (40%) to the commercial laboratory used for the interlaboratory comparison. The median time from phlebotomy to receipt in the testing laboratory was 0.7 hours for Children's and 20.72 hours for the commercial laboratory. The median time from phlebotomy to result was 1.28 hours for the Children's hospital laboratory and 38.7 hours for the commercial laboratory (Table 2). The median time from result availability to documented acknowledgment by the caregiver was 5.4 hours for Children's and 18.0 hours for the commercial laboratory.
While there was a significant difference between the time from phlebotomy to result when comparing the laboratories, the time to a result differed by less than 10% when comparing tests performed at a specific laboratory. However, there was variability in the time to result and acknowledgment by the caregiver, based not only on the location of testing but also on the test being resulted (Table 3). The shortest median time between posting and documentation of review was 3.8 hours for LDL at Children's; the longest was 25.5 hours for low density lipoprotein at the commercial laboratory. The median time from result to review for the ESR was 1.31 hours at the commercial laboratory and 5.6 hours at Children's.
The number of cancelled tests at the commercial laboratory was 155 of 5765 (2.7%), and the number of cancelled tests at Children's was 68 of 8577 (0.8%). The test with the greatest number of cancellations at the reference laboratory was the ESR assay, with 79 of 1097 (7.2%) cancelled. The Children's laboratory cancelled 9 of 1454 ESR tests (0.1%). The reasons for cancellation at the commercial lab included extended age of specimen for 63, duplicate orders for 6, quantity not sufficient for 5, and miscellaneous other reasons for 5 samples. The reasons for cancellation at the Children's laboratory were cancelled per physician request (3), no specimen received (3), unable to collect (1), wrong test ordered (1), and quantity not sufficient (1).
Cost Analysis for System to Support Testing at Commercial Reference Laboratories
Test Selection and Ordering (Pre-preanalytic)
Orders at the clinic were entered electronically into the Children's EHR. To provide caregivers a single point of order entry, test orders in the Children's EHR automatically routed the test order to the correct testing laboratory's LIS, based on the patient's primary health insurance. For example, there is only 1 order in the Children's EHR that can be selected for a CBC. When the provider chooses a CBC for his/her patient, that CBC order is mapped to the Children's laboratory CBC order code as well as the order codes for CBC at each of the reference laboratories. An automated script in the Children's EHR identifies the patient's insurance and routes the test to the correct testing laboratory using the order code for CBC that is specific to the testing laboratory. The following assessments refer to the building and testing of the interfaces, and the maintenance of the interfaces.
Establishing the Interface
Children's employed contract labor to work with internal resources, and project management records revealed that 4425 hours of information technology (IT) effort were expended from 2011–2014 to establish bidirectional interfaces between the Children's EHR and each of the commercial laboratories' LISs. This included 2425 hours of employed IT analyst/informaticist time at an estimated cost of $128,185 (using the average salary for a computer systems analyst from the Bureau of Labor Statistics), and approximately twice the financial support for internal resources was used to support IT contractors.
To establish the initial interfaces, 140 commonly placed laboratory orders were mapped to each reference laboratory in addition to the mapping that already existed to the Children's laboratory for those orders. Mapping each test required evaluation by a clinical pathologist, often in concert with a clinician in the subspecialty, to ensure that the test at the commercial laboratory was equivalent to the test at the Children's laboratory that was already mapped to the order in the EHR. This took 8 hours per week for 1 clinical pathologist for 2 years (0.2 FTE [full-time equivalent]), and an additional 20 hours a week from each of 2 other clinical pathologists for 1 month, resulting in an estimated cost in physician effort of $118,600. An example of the challenge in mapping complex tests with overlapping panels of analytes is shown in Table 4.
Clinician Test Selection and Ordering (Pre-preanalytic)
The pre-preanalytic phase of testing, as defined by Lundberg,3,5 includes clinician test selection and ordering and the systems that support this activity. In addition to the initial interface build and implementation, there is an ongoing cost to Children's to assess clinician requests for new tests or panels, to build new requested tests that traverse the interfaces for all 3 laboratories, and to modify test builds when changes occur to tests at any of the 3 laboratories (eg, test availability, specimen requirements, methodology, reference ranges). During the year of the study, this required 10 hours per week from a pathology informaticist and 10 hours per week from an Epic analyst, for an estimated cost of $61,672 and $27,847, respectively (Figure).
Additional costs not quantitated were the hours spent by IT analysts and managed care to maintain the dictionary of primary insurance providers and the testing laboratories that each required to use, clinicians' time to meet with the informaticist to confirm that the mapped tests in the 3 systems were accurate and the tests desired, and time spent identifying solutions when analytes in panels did not match between laboratories.
Sample Collection and Preparation for Testing (Preanalytic)
The preanalytic phase of testing includes patient/specimen registration, clarification of orders, specimen collection, processing, storage, preparation/packaging for transport, transport, and documentation of the above. The number of phlebotomy occurrences at Children's for samples that went to the 2 commercial laboratories was based on annualizing data from a 6-month period. During the period of the study, there were 23,883 phlebotomy experiences across all Children's sites supporting the commercial laboratories. Each episode of registration, collection and processing, storing, packaging, and preparing for pick-up took 30 minutes. This equates to 11,942 hours per year, or $232,381. Additionally, activities to clarify orders from care providers by laboratory management resulted in approximately 10 hours per week for all sites, and equates to $31,172.
Generation of Results, Reporting, Interpretation, and Follow-Up (Postanalytic)
On many occasions, the commercial reference laboratories would make changes to test order codes and/or test result codes without giving advance notice to Children's analysts supporting the Children's EHR. The commercial reference laboratories also frequently sent HL7 results messages that had incorrect client account numbers, patient names, patient dates of birth, patient sex, and/or the ordering provider identification. When any of these components were not recognized by the Children's EHR, the HL7 message with the incorrect data was automatically put into an error queue. These errors are worked by systems analysts for the EHR, in conjunction with laboratory analysts daily. While in the error queue, the laboratory results are not visible to clinical providers, and thus communication of the information is delayed. One HL7 result message typically contains many results for a single patient.
The number of HL7 result messages delayed in the interface error queue during the year of the study was 0 for the Children's laboratory to Epic interface, and 6151 for the commercial laboratories combined (Table 5). The Children's laboratory works with Children's EHR staff to ensure that test orders and results are always up-to-date before changes are made, and patients are registered in the Children's EHR, which then registers the patient in the Children's LIS automatically. This ensures accurate delivery of demographic, order, and result information. Resolving issues that caused a subset of the HL7 result messages from the reference laboratories to go to the error queue, specifically errors in order codes and result codes (37.2% of the total errors), required 28 hours per week for a senior clinical informaticist for the Children's EHR, 10 hours per week for a senior laboratory analyst, 10 hours per week for a pathology informaticist, and 4 hours per week for a clinical pathologist, equating to $192,728 per year.
In addition to the time spent to maintain interfaces in the context of constantly changing test menus, there were instances in which the issues with tests sent to the commercial labs are brought to the attention of laboratory management by the caregivers. These include issues such as lost specimens, canceled tests, delayed test turnaround time, problems with critical result reporting, finding missing reports, and communication problems. The Children's laboratory management interfaces with caregivers and meets with the commercial laboratories to address these issues on a regular basis, and this takes approximately 30 hours per week, for an estimated annual cost of $98,436.
There is additional time and cost that was not accounted for in this study, specifically time spent by caregivers in various related activities such as searching for missing tests, contacting the laboratory and/or IT staff when tests were missing or canceled, and calling patients back for re-collection. This represents wasted time and effort as well as frustrating delays for caregivers, lab personnel, and patients.
Integration of Results into the Patient Context and Subsequent Decision-Making (Post-postanalytic)
This part of the testing event is the duration between the result being reviewed by the caregiver and the point at which the caregiver acts on the information provided. Activities during this time are difficult to quantitate in terms of time, but the following impact the ability to take clinical action:
Cancelled samples requiring a decision about re-collection. In some instances, the patient returned for a repeated collection or the patient had the test done elsewhere. Also, since this was a pediatric facility and many of the patients were very young children, instead of having to subject them to repeated phlebotomy, frequently the clinician made a determination on a course of therapy without the result.
Looking for the result. The caregiver's team would call the reference laboratory to determine what happened to the specimen or, more commonly, would contact the Children's laboratory outpatient manager or pathologist to complain. The Children's outpatient manager would investigate, and then send the information to the account manager for the reference laboratory, who would also investigate.
Time to close the encounter. Many providers wait for the lab tests to result before closing the encounter in the EHR. For labs done at the outside facility, this resulted in a lag to close the charts due to the time it took for results to appear in the EHR.
This report highlights the impact of fragmented laboratory testing in a pediatric subspecialty clinic. The study quantitates delays in results due to such fragmentation and the cost burden to the Children's system, providing support for recommendations by the Institute of Medicine calling for attention to decrease fragmentation of care. The comparison of testing performed by the Children's hospital laboratory close to the point of phlebotomy versus at a commercial reference laboratory highlights a time to result from the off-site commercial reference laboratory that is more than a day longer than the local laboratory.
The CDC states that there is a gap between the actual delivery of health care and the standards desired.4 Our study quantified that gap for patient laboratory testing seen at a pediatric subspecialty outpatient clinic. While the CDC indicates that, “Timeliness of care minimizes unnecessary delays that can result in emotional or physical harm,” the routing of tests to the commercial laboratory ends in a result the day following clinic, rather than the day the patient is seen. In addition to the delay in results, there is a delay in the caregiver viewing the result after it is available in the EHR. There are more cancelled specimens for critical tests, and in the final result, the inexpensive test provided to the patient insurance by the commercial reference laboratory becomes an expense to the individual patient, caregiver, and Children's system.
In addition to a gap in the quality of laboratory care for the patient, we also identified an annual cost of more than $600,000 to Children's to support the ordering, collection, and shipping of samples to the commercial reference laboratory, and to ensure to the extent possible that the test results appeared accurately in the EHR. Ironically, the activities and expense to provide this critical support with the goal of ensuring the best possible patient care are not recognized or appreciated by the payers, and are borne by Children's, thus financially supporting the fragmented system that results in delays and cancelled results. Nine stages in the testing process have been defined, with the analytic (testing) phase the least prone to errors leading to inaccurate lab results.3,5 Paradoxically, it is the analytic phase that is reimbursed and so the economic driver for laboratory medicine is attributed to the least complex part of the process. If the analytic part of the process is removed from the system of care, as is the case when tests are routed to commercial laboratories, based on insurance specifications, there are delays. Additional hidden costs are incurred in order to ensure the result is seen by the caregiver as an integral part of the diagnostic process.
Some of the limitations to this study revolve around differences in laboratories and health systems. Some health systems do not have this fragmentation because testing is not routed to commercial laboratories for tests that are performed in-house. Other health systems do not integrate the ordering and reporting into the EHR, which shifts the burden of finding the result to the caregiver instead of the laboratory. The system we used attempted to have the least amount of impact on the caregiver when laboratory testing was performed at a commercial laboratory. We implemented a computer interface into our EHR so that orders could be placed and results received electronically. However, ensuring that test orders are correct and that results post back into the EHR takes resources, primarily in the form of computer analysts, clinical pathologists, and a pathology informaticist. The Children's laboratory instituted phlebotomy collections at the pediatric subspecialty clinics in 2014 to address complaints from the caregivers when pediatric phlebotomy was performed by the commercial reference laboratory phlebotomists. For that reason, Children's provides pediatric phlebotomy and also fields complaints when testing goes awry. In addition to the tangible monetary costs to the Children's care system, there are less quantifiable costs to the caregiver and patient. This includes the delay in result when testing is sent to the commercial laboratory, the higher number of rejected specimens, the higher number of re-collections required, and the delay in acknowledging receipt of results after they are present in the EHR, possibly a reflection of the interruption of workflow produced by the result being posted the day after the patient was seen. It is important to acknowledge the difference in expectation related to the time from phlebotomy to result when testing is performed at the local Children's laboratory versus the commercial laboratory. Aside from time in transport, there is a difference in the expected time to result once the test arrives in the laboratory, with the Children's laboratory being 4 hours for a routine test and the commercial laboratories being between 1 and 2 days for the tests analyzed in this study. These differences may result in a lack of clarity related to when the results are available from the commercial laboratories, and therefore a delay in the clinician acknowledging the result once it is available in the EHR.
With reference to one of the tests, the ESR, most of the cancellations occurred at the reference laboratory owing to the age of the specimen. Despite best efforts, the transport of the specimen by the commercial laboratory courier from the Children's draw site to the reference laboratory, which was out of state, resulted in specimen rejection due to age. Most of these were from the rheumatology clinic, where the ESR is used to monitor disease severity and guide therapy. The American College of Rheumatology guidelines indicate that therapy be based on disease activity, which includes a combination of clinical findings and ESR or CRP testing.7 Without a test result, the physician is left to have the patient undergo a redraw, or to manage the patient with incomplete information.
Hendrickson et al8 reported the impact of a systems-approach to laboratory testing when combined with an outpatient endocrinology clinic visit. The authors reported a stepwise quality improvement initiative, identifying that having the laboratory testing performed immediately before the first clinic visit, with results available at the visit, improved care in many ways. Previsit lab testing contributed to significantly more visits with complete information at the time of the clinic appointment. All clinicians indicated that the overall quality of care improved with previsit laboratory testing, efficiency improved, and most recognized more time for hands-on patient care and a system with less waste. Further, all reported spending less time after the visit gathering necessary information.
Another recommendation from the Institution of Medicine to improve the quality of health care is to ensure equity of care.9 States the mandate: providing care that does not vary in quality because of personal characteristics such as gender, ethnicity, geographic location, and socio-economic status. Our study identified inequity of care based on insurance providers but, as opposed to those with lower incomes often receiving poorer care, those with Georgia Medicaid received more rapid turnaround times, with less specimens rejected and a caregiver who viewed the results within a few hours of the results being posted.
The authors would like to acknowledge the work and support of the following people, who were instrumental to data collection and analysis: James Bost, PhD, Darlene Gomez, BS, Patrick Houlihan, James Laidley, MBA, Courtney McCracken, PhD, Jack McMillan, Carolyn Silzle, MS, MBA, RDN, Brigitte Thompson, AAS, Mikiki Williams, and Tanya Wright, BS.
The authors have no relevant financial interest in the products or companies described in this article.