Journal Entry 1

100 Am J Clin Pathol 2015;143: 100 -104 DOI: 10.1309/ AJCPM0O7MNVGCEVT © American Society for Clinical Pathology AJCP / Original Article Downtime Procedures for the 21st Century Using a Fully Integrated Health Record for Uninterrupted Electronic Reporting of Laboratory Results During Laboratory Information System Downtimes Bulent Oral, 1 Regina M. Cullen, 1 Danny L. Diaz, 1 Eldad A. Hod, MD, 2,3 and Alexander Kratz, MD, PhD 2,3 From 1 Information Services, NewYork-Presbyterian Hospital, New York, NY; 2Department of Pathology and Cell Biology, Columbia University College of Physicians and Surgeons, New York, NY; and 3Clinical Laboratory Services, NewYork-Presbyterian Hospital, New York, NY. Key Words: Informatics; Management/administration; Generalist; Laboratory informat\ ion system; Downtime; Electronic medical record; Scanning Am J Clin Pathol January 2015;143:100-104 DOI: 10.1309/AJCPM0O7MNVGCEVT ABSTRACT Objectives: Downtimes of the laboratory information system (LIS) or its interface to the electronic medical record (EMR) disrupt the reporting of laboratory results. Traditionally, laboratories have relied on paper-based or phone-based reporting methods during these events.

Methods: We developed a novel downtime procedure that combines advance placement of orders by clinicians for planned downtimes, the printing of laboratory results from instruments, and scanning of the instrument printouts into our EMR.

Results: The new procedure allows the analysis of samples from planned phlebotomies with no delays, even during LIS downtimes. It also enables the electronic reporting of all clinically urgent results during downtimes, including intensive care and emergency department samples, thereby largely avoiding paper- and phone-based communication of laboratory results.

Conclusions: With the capabilities of EMRs and LISs rapidly evolving, information technology (IT) teams, laboratories, and clinicians need to collaborate closely, review their systems’ capabilities, and design innovative ways to apply all available IT functions to optimize patient care during downtimes. Accurate, fast, and reliable communication of laboratory results to clinicians is a crucial prerequisite for effective and efficient patient care. In most hospitals, this communication is accomplished through interfaces that link laboratory instruments to the laboratory information system (LIS) and the LIS to the electronic medical record (EMR). This setup allows almost immediate transmission of verified laboratory results to all clinicians who have access to the EMR. Interfaces and LISs can become unavailable due to planned maintenance or because of unexpected hardware or software malfunctions. 1 Both scheduled and unscheduled downtimes occur with significant frequencies. In 1996, a College of American Pathologists Q-Probes study polled 422 laboratories and found a median of eight downtime episodes during a 30-day study period. 2 A follow-up study of 97 laboratories published in 2003 showed a decrease to a median of three events per 30-day period. 3 Downtimes can severely disrupt clinical workflows and affect patient care throughout a health care system. 4 They are also associated with the need for additional labor in the laboratory and for information technology (IT) teams; decreased patient, clinician, and laboratory personnel satisfaction; and significant costs. 5 Most hospitals have downtime procedures for times when the LIS or the interface between the LIS and the EMR is not available. These plans often include the use of phone calls, faxes, or the delivery of printed reports for the communication of urgent laboratory data such as critical values or results for patients in the emergency department (ED) or the intensive care units (ICUs). Most of these strategies are paper based; this limits the availability of the data and consumes significant amounts of valuable time of both clinicians and laboratory workers. AJCP / Original Article Am J Clin Pathol 2015;143: 100 -104 101 DOI: 10.1309/ AJCPM0O7MNVGCEVT © American Society for Clinical Pathology We describe a novel way to report laboratory results during LIS or interface downtimes. Our method maximizes the use of electronic resources before and during these events by combining the downloading of orders to laboratory instruments before planned downtimes with the scanning of urgent laboratory results directly into the EMR during the downtime.

Materials and Methods Site The Columbia University Medical Center (CUMC) campus of NewYork-Presbyterian Hospital (NYPH; New York, NY) is a tertiary and quaternary care academic medical center with more than 1,000 adult and pediatric inpatient beds. Three EDs (adult, pediatric, and psychiatric) and eight ICUs (adult surgical, cardiac, cardiothoracic, and two medical ICUs; pediatric general, pediatric cardiac, and neonatal ICUs), together with active surgical, transplant, and interventional cardiology and radiology services, require reliably fast reporting of stat results to large teams of medical professionals. The laboratories receive on average over 10,000 samples a day. More than 25% of these samples are sent stat.

Information Technology in Use Our hospital uses the Sunrise Enterprise Eclipsys 5.5 (Allscripts, Chicago, IL) as the EMR. Our LIS is Cerner Millennium, version 2012.1.19 (Cerner Corporation, North Kansas City, MO). Laboratory data generated in the hospital’s laboratories are transmitted via an interface from the LIS to the EMR and displayed in the EMR’s “Results” section. For patient information that is paper based, the RegScan document workflow solution from Streamline Health (Williamsport, PA) is used to display scanned documents in the EMR. The hospital uses this function for the display of paper documents provided by patients or outside providers or hospitals, forms, and laboratory reports from reference laboratories that are not interfaced to our LIS. The system allows full integration of the EMR with paper-based clinical documentation, allowing document management to be seamlessly integrated with the rest of the EMR. Clinicians can access all needed clinical information remotely via a single access point, the EMR. 6,7 Scanning of Instrument Printouts for Display in the EMR Laboratory personnel use the password-protected RegScan program to enter a patient’s medical record number and encounter number. The program then displays the patient’s name. The technologist verifies the patient’s name against the printout and chooses “Laboratory Report” as the document type. He or she then uses a Canon Imageformula DR-2510c document scanner (Canon USA, Melville, NY) connected to his or her computer to scan in the documents.

Files are sent in TIFF format to a Streamline datacenter and stored there. When users at NYPH open the “Paper Documents” tab of Eclipsys and select a laboratory report, the documents are displayed by Streamline in an Eclipsys window via a live interface.

Instrument Printouts Our laboratory compares instrument printouts with the displays in the inpatient and outpatient EMRs on a regular basis. This is part of our quality assurance program to ensure accurate transmission of results. Scanned instrument printouts included name and address of the reporting laboratory, patient’s name and medical record number, date and time of the release of the report, the specimen type, the test results with units of measurements, and conditions of the specimen that may have limited adequacy of testing (eg, hemolysis, icteric). The name of the physician of record or of the legally authorized person ordering the test was available in the EMR with other information about the test order; reference intervals were available in the laboratory’s online test dictionary, which remained functional throughout the downtime. The collection times for the specimens were recorded on paper by the phlebotomists but were not available in the EMR. In our hematology section, middleware (Sysmex WAM, Sysmex, Kobe, Japan) handles delta checks and autoverification. The LIS is set to autoverify all results sent by the hematology middleware. Technologists were therefore able to finalize hematology results during the LIS downtime in the middleware just like during normal operations. In our chemistry and immunochemistry sections, middleware is not used for autoverification and delta checks.

We were therefore not able to perform delta checks or autoverification during the downtime. Flags (eg, hemolysis, icterus) were displayed on the instrument printouts. If a report needs to be amended, the amended printout would be marked “amended report” and scanned in.

Results CUMC/NYPH experiences LIS or interface down - times of more than 2 hours approximately twice a year.

Almost all these downtimes are planned in advance and are needed for upgrades or maintenance of the system. Our downtime procedures until 2013 called for all samples, Oral et al / LIS Downtime Procedure 102 Am J Clin Pathol 2015;143: 100 -104 DOI: 10.1309/ AJCPM0O7MNVGCEVT © American Society for Clinical Pathology including morning draws, to be sent labeled with the patient’s name and medical record number and a paper requisition. Laboratory staff then relabeled the samples with previously prepared, barcoded downtime labels and manually programmed the instruments to perform the ordered assays on each sample. After the downtime, all orders were entered from the requisitions into the LIS, the downtime numbers were electronically matched with the orders, and results were transmitted from the instruments to the LIS and from the LIS to the EMR. The protocols relied on phone calls, faxes, and printouts to communicate the most urgent laboratory results to clinicians during the downtime. Instrument printouts were hand-delivered by laboratory personnel to the EDs and ICUs. Due to the large number of patients in our medical center, these paper-based methods required extensive sorting of printouts by labora - tory and clinical staff, distracting them from their patient care responsibilities. For patients who were not in ICUs and EDs, clinicians had to call the laboratory for urgently needed results. Technologists would then find the instru - ment printouts with the patients’ results and read them to the clinical staff, who would write them down and read them back to the technologists. Due to staffing limitations in the laboratory and the clinical units, this approach could only be applied to the most urgent cases ❚Table 1 ❚. Since 2010, our IT system has allowed trained users to scan document files for display in a “Paper Documents” sec - tion of the EMR. The laboratories were using this function mainly to display reports from noninterfaced reference laboratories. In 2013, the leadership of our IT group sug - gested incorporating the scanning functionality into our LIS downtime procedure. Our new downtime protocol ❚Table 2 ❚ was developed in meetings of the LIS team, laboratory leadership, and representatives of the clinical staff of the ICUs, the EDs, and routine inpatient units. The goal of the new downtime procedure was to provide laboratory results electronically to clinicians in critical care areas and in ED settings while the LIS or interface was still down. For stable patients in other units, the goal was to keep the turnaround times for morning draws as close to normal as possible. The protocol empha - sized communication among the IT team, the laboratory, and clinical staff, both before and during the downtime. Our new standard operating procedure was first used in early 2013 in a planned downtime scheduled for a routine upgrade to the LIS. The downtime was scheduled from midnight to 10:00 am during a night between Friday and Saturday. Clinical staff were asked to place all orders for morning draw and timed draw phlebotomies by 10:00 pm on the evening before the downtime. Shortly after 10:00 pm , before the start of the downtime, barcode labels for these orders and draw lists were printed, and the IT team changed the order status of all orders for morning draws and timed draws from “ordered” (and awaiting collection) to “received in the laboratory.” This caused all the orders to download from the LIS to the instruments. Custom interface scripting ❚Table 1 ❚ Methods for Communicating Laboratory Results to Clinical Staff During LI\ S or Interface Downtimes Method Advantages Disadvantages Dedicated printers in EDs and ICUs that are directly connected to the LIS Can easily be initiated if the interface to the EMR or the EMR itself is down Not applicable during LIS downtime Provides laboratory results without need for significant additional labor in the laboratory Clinical staff needs to distribute printouts within the unit Only one hardcopy of the results is available; no electronic access Instrument printouts are hand-delivered to EDs and ICUs by laboratory staff Provides clinicians with clinically necessary information Laboratory staff needs to sort and deliver printouts to units Clinical staff needs to distribute printouts within units Only one hardcopy of the results is available; no electronic access Clinical staff calls laboratory for results on patients with urgent clinical needs; laboratory then reads results over the phone or faxes them to the unit Targeted use of resources—communication efforts are concentrated on patients with greatest clinical needs Requires significant time and effort of laboratory staff (answering phones, finding results on instruments, calling or faxing results) Requires significant time and effort of clinical staff (calling, spending time on hold, finding a specific patient’s results among other patients’ faxes) Scanning laboratory results as TIFF files into the EMR Laboratory results become available electronically during the downtime with minimal delay Requires scanning equipment and a system for display of scanned documents in the EMR Can be efficiently performed for large numbers of reports, allowing the reporting of morning draws of entire units Uses laboratory personnel time Requires advance education of clinical staff on location of reports in the EMR ED, emergency department; EMR, electronic medical record; ICU, intensive\ care unit; LIS, laboratory information system. AJCP / Original Article Am J Clin Pathol 2015;143: 100 -104 103 DOI: 10.1309/ AJCPM0O7MNVGCEVT © American Society for Clinical Pathology built in house was used to block the bogus collection and in-labeling times from being displayed in the downstream systems; this avoided confusion of the clinical staff. The custom interface scripting was done by a member of our LIS team (R.M.C.). The time required (including testing and validation) was approximately 3 hours. During the downtime from midnight to 10:00 am , morning draws took place like any other night, using the labels and draw lists created before the downtime. Upon arrival in the laboratory, samples from the morning draws could be analyzed as usual, since the orders had already been downloaded to the instruments. After analysis, results from ICU patients were printed from the instruments, matched with the patients’ encounter numbers, scanned, and downloaded for immediate availability in the “Paper Documents” section of the EMR. The advance ordering of laboratory testing was not practical for patients in the EDs, operating rooms, interventional cardiology units, or any other situation in which an urgent need for laboratory testing arose after the 10:00 pm deadline. For these patients, clinicians were instructed to use paper requisitions for the ordering of laboratory tests and to note the patients’ encounter number on the requisition. Upon arrival of the samples in the laboratory, the orders were manually placed in the instruments, samples were analyzed, results were printed out, and printouts were scanned and downloaded to the EMR. After the downtime, orders were placed in the LIS and connected to the downtime accession numbers of the results already obtained, and results were downloaded from the instrument. Results from morning draws from routine, non-ICU patients were held in the instruments and not reported during ❚Table 2 ❚ Procedure for Planned Downtimes of the LIS or LIS-EMR Interface Using an\ Integrated EMR One to 2 weeks before planned downtime Emails are sent to hospital staff to inform them of the planned downtime\ .

Clinical leadership, senior hospital administrators, laboratory IT team,\ and laboratory management meet and finalize details of the downtime (start time, duration, areas affected, etc). Two days before planned downtime All hospital staff are reminded of coming downtime via emails and messag\ es on their computer screens.

Emails are sent to all clinicians who have ordering privileges (residen\ ts, attending physicians, nurse practitioners), reminding them of the planned downtime and asking them to place all orders for morning draws 2\ hours before the beginning of the downtime. One to 2 hours before the downtime Reminders of the planned downtime continue to be sent to clinicians.

The IT team generates an Excel file of all inpatients’ names, their m\ edical record numbers, and their encounter numbers. This file is sent to the laboratory.

Morning-draw labels are printed to colored label stock to distinguish th\ em from nonmorning-draw labels. Draw lists for morning draws are printed.

The status of all morning-draw samples is changed to “received” in\ the LIS (even though they have not been drawn yet). This downloads all morning-draw orders from the LIS to the instruments, allowing for an\ alysis when the samples arrive in the laboratory later during the downtime. Custom interface scripting blocks the bogus collection tim\ es and in-laboratory updates from being displayed in the downstream systems, thereby avoiding confusion of clinical staff. During downtime Morning-draw ICU samples All morning-draw phlebotomies proceed as usual, using draw lists and lab\ els printed before the downtime.

As far as possible, separate instruments are sequestered for use for spe\ cimens from the ICUs. These instruments are programmed to print out paper reports for all completed \ orders.

Using the Excel file with the financial (encounter) number, technologi\ sts match each result printout with the correct financial number and scan the printout into the patient’s EMR\ file.

Results are available in the “Paper Documents” section of the EMR \ to all staff during the downtime. All clinically urgent samples that are not from the ICU morning draws (eg, all ED samples, all samples from the operating rooms and interventional cardiology suites) Staff are instructed to use paper requisitions during downtime and to wr\ ite the patient’s encounter number on each requisition.

Label color is used to identify these samples as urgent.

Upon arrival in the laboratory, orders are manually entered into the ins\ truments, samples are analyzed, and results are printed from the instruments.

Result printouts and requisitions (which contain the financial number)\ are paired up, and result printouts are scanned into the EMR.

Results are available in the “Paper Documents” section of the EMR \ to all staff during the downtime. Nonurgent samples from routine care units Morning draws proceed as usual, using the draw lists and labels printed \ before the downtime.

Upon arrival of these samples in the laboratory, they are analyzed on de\ dicated instruments (in-labing and downloading of orders to the instruments has occurred before the downtim\ e).

Results are held in the instruments until the end of the downtime, unles\ s a clinician calls and asks for the results. After downtime After downtime ends, all results obtained during the downtime are transm\ itted from the instruments to the LIS and EMR, making the results available in the “Results” section of the EMR. The comment\ “Processed during system downtime. Collect and received date not updated” is added to all results from the morning draws and timed\ draws. ED, emergency department; EMR, electronic medical record; ICU, intensive\ care unit; IT, information technology; LIS, laboratory information syst\ em. Oral et al / LIS Downtime Procedure 104 Am J Clin Pathol 2015;143: 100 -104 DOI: 10.1309/ AJCPM0O7MNVGCEVT © American Society for Clinical Pathology the downtime unless clinical staff called and indicated that results were urgently needed. After the end of the downtime, all results obtained during the downtime were downloaded from the instruments to the LIS and from the LIS to the EMR. The comment “Processed during system downtime; collect and received date not updated” was automatically added to all results. Twenty randomly selected reports from ED and ICU patients indicated that the average time between availability of printouts for scanning and completion of scanning was 64 minutes (range, 20-118 minutes). Review of the reporting of the morning draws showed that results started to appear in the results section of the EMR within minutes of the end of the downtime. By 9:00 am , 27% of the routine morning draws had been transmitted to the EMR. This compared favorably with 38% on the Saturday before and 13% on the Saturday after the downtime. By noon, 71% of all morning draws were transmitted, compared with 98% one week before and 92% one week after the downtime. One week after the downtime, a meeting was held to assess the success of the new downtime procedure.

Clinicians’ feedback was obtained in meetings of laboratory leadership with IT and clinical staff. The feedback was consistently positive; clinicians appreciated the ability to access laboratory results during the downtime electronically and the fact that morning draw results were available with only minimal delays. The laboratory staff noted that the new system made recovery after the downtime much easier than the previous approach.

Discussion Growing multisite health care organizations, interfaces with often dozens of upstream and downstream systems, and changing regulatory requirements that require updates to the LIS all contribute to the frequency with which IT systems need to be taken down for upgrades and maintenance. These factors also make networks more complicated and thereby increase the likelihood of unexpected system failures.

Most laboratories are aware that conventional ways to communicate laboratory results during downtimes, such as printouts, faxes, and phone calls, are not able to adequately transfer the large amount of information produced by modern laboratories with the needed reliability and speed. We describe a novel method to provide laboratory results to clinical staff during downtimes. Our approach combines the advance downloading of orders for scheduled phlebotomies from the LIS to laboratory instrumentation for planned downtimes with the scanning of instrument printouts into the EMR during all downtimes. The approach can be modified for unplanned downtimes and emergency testing to a process consisting of manually programming the laboratory instruments to perform the testing and then scanning the instrument printouts into the EMR. Advantages of our approach over conventional methods include fast availability of large amounts of data to clinical staff in electronic format, accessible through the EMR from multiple locations. Our protocol also reduces the amount of time laboratory staff have to spend to answer phones, track down clinical staff, or send faxes. Most important, it eliminates patient safety issues caused by transcription errors when results are orally communicated over the phone or sent via fax to the wrong location. The ability to continue analysis of morning draws during planned downtimes should allow faster recovery after the downtime and has the potential to improve clinical outcomes and to decrease hospital length of stay, all important factors for patient and physician satisfaction. Like all procedures in modern medicine, the success of a downtime procedure depends on the close cooperation of multiple teams. IT staff, laboratory employees, and clinicians need to work closely together on the design of the downtime procedure, the timing of the event, and the training of all levels and groups of staff. Service expectations, both during and immediately after the downtime, need to be carefully managed.

Address reprint requests to Dr Kratz: Columbia University Medical Center, NewYork-Presbyterian Hospital, Core Laboratory, 622 W 168th St, PH3-363, New York, NY 10032; [email protected].

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