Ventura County Grand Jury • 2014-2015

Ventura County Electronic Health Record Implementation Risks

Published: June 11, 2015 22 pages
View Original PDF

Findings and Recommendations 51 findings

F01
The Grand Jury found that after Go-Live a significant level of concern was raised by clinical staff to IT regarding potential impacts of observed EHR- related risks on patient well-being. (FA-27, FA-37, FA-42, FA-43, FA-44)
No recommendations for this finding
F02
The Grand Jury found systemic deficiencies in the process used by VCHCA to develop and vet the adequacy of the EHR project requirements specification. For example:  The “number of simultaneous users” specification was clearly developed using an inadequate analysis strategy, and the specification reasonableness was not validated by appropriate independent EHR SMEs.  A performance requirement for a maximum window update time was not developed. VCHCA failed to develop a mutually agreeable 12 Ventura County EHR System Implementation Risks specification with Cerner in the contract, as part of an EHR acceptance requirement.  VCHCA did not have an effective mechanism to gauge the comprehensiveness and quality of the EHR implementation and its test development process.  VCHCA did not specify the minimum required FTE staffing level that IT/Informatics management and an independent EHR SME agreed was both necessary and sufficient to fully accomplish the goals of the project. Without this staffing it was not possible to conduct rigorous testing in the time period specified by the Cerner Event Driven Project file. (FA-02, FA-05, FA-09, FA-10, FA-17, FA-26)
No recommendations for this finding
F03
The Grand Jury found no evidence that project requirements were formally specified, which precluded generating a complete and quantifiable test plan to verify overall EHR quality throughout the Implementation stage. The actual project was guided primarily by untestable goals to meet the federal Stage 1 attestation. (FA-02, FA-17, FA-22, FA-41, FA-42)
No recommendations for this finding
F04
The Grand Jury found no effective independent review of the EHR project before the release of the RFP, before contract signing, nor continuing periodically during the course of the project. Such an independent review would include SMEs from outside the VCHCA who have EHR Implementation experience and also clinical staff with experience in the VCHCA. (FA-02, FA-05, FA-17, FA-28, FA-29)
No recommendations for this finding
F05
The Grand Jury found that the lack of an effective Risk Management Plan resulted in significant impact on project quality and cost. Developing and maintaining such a plan would have exposed potential problems and triggered mitigations that could have avoided or lessened the undesirable consequences. For example, training did not satisfactorily address learning retention losses with timely hands-on refresher courses using an EHR domain and more robust training materials. Nor did it adequately stress the importance of accuracy using discipline-specific examples of correct vs. incorrect situations (e.g., data entry accuracy). (FA-03, FA-10, FA-17, FA- 27, FA-39, FA-46)
No recommendations for this finding
F06
The Grand Jury found that EHR project execution was directed solely by the Cerner Event Driven Methodology and key events and dates in the Cerner Microsoft Project file—to the exclusion of other important VCHCA- specific considerations. The EHR Implementation had significant undis- covered problems at Go-Live caused by issues such as: the inflexible July 1, 2013 Go-Live date; the 14-month integration schedule; the lack of slack in the schedule; and the lack of documented testable requirements before proceeding to the next stage. As a consequence, waiting to address residual quality issues (e.g., software bugs) until after Go-Live made patient care more challenging in the interim. However, due to alert staff, Ventura County EHR Implementation Risks 13 temporary workarounds were developed to maintain patient care standards. (FA-12, FA-13, FA-22, FA-26, FA-43)
No recommendations for this finding
F07
The Grand Jury found that, by failing to have quantitative data to predict impacts on the Go-Live date, project management was unable to convince VCHCA administration to support the project staffing levels and ordering dates of materials necessary to deliver an operationally acceptable product. EHR project management did not utilize industry-accepted best practices project management techniques (e.g., PMI) for project planning and quantitative reporting of VCHCA labor and material schedules, nor for status against those schedules. (FA-12, FA-13, FA-14, FA-15, FA-24, FA- 26, FA-28, FA-29, FA-31, FA-32, FA-33, FA-36, FA-37, FA-38, FA-39, FA- 40, FA-41, FA-42, FA-48, FA-49)
No recommendations for this finding
F08
The Grand Jury found that VCHCA research and ITC status reports both indicated a shortage of personnel assigned to the EHR project. However, VCHCA and ITC failed to take the necessary and timely corrective action. (FA-26, FA-28, FA-29)
No recommendations for this finding
F09
The Grand Jury found that VCHCA failed to develop a project plan to reflect VCHCA staffing hours and resources necessary to integrate with the Cerner production schedule. (FA-13) Recommendations
No recommendations for this finding
F10
Cerner would not agree to any requirement on window update time in the contract. Most clinical staff users consider any update time exceeding 2 to 3 seconds unacceptable because it affects concentration and degrades productivity. [Ref-04]
No recommendations for this finding
F11
After agreeing on terms and conditions, Cerner and the County negotiated Cerner Contract No. 6433 for development of the VCHCA EHR project. [Ref- 04, Ref-10]
No recommendations for this finding
F12
The contract required Cerner to develop a “Work Plan” that would describe mutual expectations and work to be performed by Cerner and VCHCA during the EHR delivery. The Cerner Work Plan was supposed to contain detailed information, including but not limited to schedule, tasks, estimates, durations, deliverables, critical events, task dependencies, resource assignments, specifications, and payment schedules. No provision of the Cerner EHR contract limited VCHCA to exclusively use the Cerner Work Plan for managing VCHCA labor and/or material. [Ref-04]
No recommendations for this finding
F13
The Work Plan Cerner delivered during the course of the project was documented in a Microsoft Project file. This file was described by VCHCA as reflecting the Cerner “Event Driven” Project Management Methodology. Cerner Event Driven Project files contain only Cerner-owned tasks, with scheduling and manpower loading. They do not contain any VCHCA labor hours. The key event in the schedule was the project Go-Live milestone of July 1, 2013. VCHCA’s project manager was expected to ensure that VCHCA maintain this schedule in order to qualify for the financial incentives of HITECH Stage 1 Meaningful Use. [Ref-03, Ref-04] Upon examining the Cerner Microsoft Project file for “Implementation” Phase 1 of the EHR project—spanning the time period from “contract signing” (October 2011) through “end of maintenance” (October 2013)— the Grand Jury observed that:  Cerner did not “populate” the project file with any VCHCA labor tasks or hours.  VCHCA did not augment the project file with its own staff resources and tasks. Ventura County EHR Implementation Risks 5  VCHCA did not create any independent project plan for the VCHCA staffing resources and tasks.
No recommendations for this finding
F14
As indicated in VCHCA’s response to the 2013-2014 Grand Jury report “Healthcare Records Processes and Procedures,” VCHCA EHR Implementation resources were coordinated to link up with key-event dates specified in Cerner’s Event Driven Project plan (e.g., Project Kick- Off, four trips to Kansas City, Unit & Integration Test, and Go-Live deadline). The Cerner project file provided a list of milestones and expected dates that VCHCA had to meet to achieve the established Go-Live date. [Ref-05]
No recommendations for this finding
F15
Throughout the Implementation period, VCHCA management and staff status reporting was handled at weekly or as-needed staff meetings. Project management coordination between Cerner and VCHCA was handled at weekly or as-needed teleconferences or in-person meetings.
No recommendations for this finding
F16
All County IT projects must receive the approval of the ITC for large projects and purchases. The ITC requires the project sponsor to complete the Automation Project Assessment Questionnaire (APAQ). This document outlines the project description, scope, objectives, risk assessment, outcome, and measurements for success. The APAQ form can be found on the County Forms & Policy (F&P) Intranet website.
No recommendations for this finding
F17
The October 3, 2011 APAQ for the Cerner EHR project presented to the ITC identified three goals, one measurement for success, and a minimal risk assessment.  Goal 1: To replace VCHCA’s clinical record system with a single system that complies with the HITECH provision of ARRA  Goal 2: To automate and integrate the patient accounting and supply chain management with the new clinical record system  Goal 3: To automate and integrate billing and claim management for leveraging information across the County  Measurement: The single measure of this project’s success would be achieving its first “attestation” in accordance with federal requirements under the “Stage 1 Meaningful Use” criteria by September 1, 2013.  Risk assessment: Risk would be limited to the loss of federal reimbursement allocations and the issuance of fines if the project was not started by January 1, 2012, and completed by September 1, 2013.
No recommendations for this finding
F18
On October 4, 2011, the BOS approved $32 million to acquire the Cerner EHR system. This appropriation did not include provisions for computer hardware, staffing, or medical hardware, which were to be determined at a later time and funded out of VCHCA’s operating budget. [Ref-10]
No recommendations for this finding
F19
As indicated in VCHCA’s response to the 2013-2014 Grand Jury report “Healthcare Records Processes and Procedures,” Cerner was responsible for system design and acquisition of the Ventura-based server farm and 6 Ventura County EHR System Implementation Risks some Cerner-specific end-user hardware. VCHCA was responsible for generic end-user hardware such as workstations, laptops, barcode scanners, and printers. [Ref-05]
No recommendations for this finding
F20
Cerner performed the overall EHR system design based on VCHCA’s parameters (i.e., 600 simultaneous users, 56 Solutions, 2 hospitals, 40 clinics, and a Ventura-hosted server farm). [Ref-05, Ref-09]
No recommendations for this finding
F21
EHR Project Kick-Off for VCHCA was originally planned by Cerner for month three of the contract timeline (January 2012) but did not happen until May 2012 (month seven)—a four-month schedule slip.
No recommendations for this finding
F22
During the EHR Implementation Phase 1, Cerner was responsible for the EHR “Build” process that customized the basic Cerner framework to implement the specific VCHCA workflow. Cerner Clinical Strategists—working in conjunction with VCHCA-selected analysts, SME staff who were familiar with the workflow (operating as Informatics personnel in training), and VCHCA-hired contractors—were primarily engaged with Implementation tasks. Implementation involved describing, modifying, and improving the hospital and clinic workflows using formatted Cerner Design Control Worksheets (DCWs). Implementation also involved reviewing interim functionality and testing for correct Build functionality and accuracy.
No recommendations for this finding
F23
VCHCA had three methods to get the staff needed for the Implementation: 1) share existing VCHCA staff; 2) share personnel from County IT staff; and 3) hire outside contractors.
No recommendations for this finding
F24
In December 2011 VCHCA recognized the need to hire contract staff to help meet staffing requirements. In July 2012 (month nine of the original timeline) the BOS approved hiring requested contract staff. [Ref-12]
No recommendations for this finding
F25
The HITECH Act, by requiring a short compliance period and offering enticing grant subsidies, reduced the pool of available qualified Informatics personnel. VCHCA and all other hospital and clinic institutions and EHR providers (including Cerner) were competing nationwide to secure needed Informatics staff. This situation complicated VCHCA’s ability to recruit and hire qualified EHR talent.
No recommendations for this finding
F26
VCHCA did not provide sufficient analyst and SME staff to meet scheduled key dates:  Many other comparable-size Cerner customer institutions employ over 50 Informatics support staff.  Cerner’s original estimate for VCHCA’s labor for Implementation was 31.5 experienced Full-Time Equivalent (FTE) staff (analysts and SMEs). [Ref-04]  The APAQ for the EHR stated that approximately 30 dedicated clinical analysts would be needed. [Ref-11] Ventura County EHR Implementation Risks 7  VCHCA provided on average 24 FTE staff to support Phase 1 Implementation: o 14 full-time VCHCA staff (=14 FTE) o 22 part-time “borrowed” VCHCA staff (=5 FTE) o 5 full-time contractors (=5 FTE)  VCHCA management and staff did not have prior hands-on experience with Cerner system Solutions Implementation, Build, or Maintenance.  Limiting staffing to less than Cerner-recommended and IT-requested levels helped VCHCA hold down costs. It also delayed efforts to identify and fix EHR quality issues (e.g., “bugs”) until after Go-Live.
Related Recommendations (1)
R04
The Grand Jury recommends that the Board of Supervisors direct the VCHCA to establish an Informatics Department with appropriate full-time staffing to satisfy the needs for maintenance and future upgrades of the VCHCA EHR. To be effective in this role, the Informatics Department should 14 Ventura County EHR System Implementation Risks report directly to clinical VCHCA management to ensure that patient care is always given proper clinical concern and priority. (FI-02, FI-03)
F27
Since Go-Live VCHCA has had a chronic shortage of available Report Writers. Report Writers are skilled in the extraction of data from the EHR database and producing formatted reports and statistics needed by various healthcare departments. VCHCA staff found that many of the stock Cerner reports did not produce the statistics or data needed by requesting departments. In March 2015 VCHCA had a backlog of over 35 reports. A typical report takes four to eight weeks to create.
Related Recommendations (1)
R04
The Grand Jury recommends that the Board of Supervisors direct the VCHCA to establish an Informatics Department with appropriate full-time staffing to satisfy the needs for maintenance and future upgrades of the VCHCA EHR. To be effective in this role, the Informatics Department should 14 Ventura County EHR System Implementation Risks report directly to clinical VCHCA management to ensure that patient care is always given proper clinical concern and priority. (FI-02, FI-03)
F28
Throughout the EHR Implementation in 2012 and 2013, the required ITC quarterly Project Status Reports indicated the following concerns (without quantitative supporting backup):  The project experienced delays with the design of a few modules due to lack of personnel allocations. Additional staff would have been needed to make up the lost time.  Delays in approval for additional staff impacted the ability to meet milestones for the design phase.
No recommendations for this finding
F29
Neither ITC nor VCHCA took corrective action regarding the risks resulting from staff shortages and the related consequences as documented in the quarterly ITC reports.
Related Recommendations (1)
R05
The Grand Jury recommends that, for any future capital projects of the VCHCA, the Board of Supervisors assign to the ITC the responsibility and authority to: regularly monitor achievement of stated project goals; ensure compliance with the approved project process; enforce utilization of quantitative data to measure project progress; identify problems; and assure that prompt corrective action is taken. (FI-03, FI-04, FI-05, FI-07, FI-08, FI-09) Responses Responses required from: Ventura County Board of Supervisors (FI-02, FI-03, FI-04, FI-05, FI-06, FI-07, FI-08, FI-09) (R-01, R-02, R-03, R-04, R-05) Responses requested from: County of Ventura, County Executive Officer (FI-02, FI-03, FI-04, FI-05, FI-06, FI-07, FI-08, FI-09) (R-01, R-02, R-03, R-04, R-05) Ventura County Health Care Agency (FI-02, FI-03, FI-04, FI-05, FI-06, FI-07, FI-08, FI-09) (R-01, R-02, R-03, R-04)
F30
VCHCA did not perform simulated or actual load testing before Go-Live. Testing could possibly have exposed storage capacity limitations, response time problems, and other limitations in the EHR system.
No recommendations for this finding
F31
Beginning at Go-Live on July 1, 2013, and for several weeks thereafter, much of the staff had difficulty logging into the EHR system to access patient records. To overcome this situation VCHCA had to rapidly purchase and install an additional 600 Citrix licenses and triple the number of servers in the server farm by July 30, 2013. VCHCA acknowledged this situation was a direct result of underestimating the number of simultaneous users at 600. [Ref-05, Ref-09]
No recommendations for this finding
F32
After adding the 600 Citrix licenses and tripling the servers in July 2013, a new problem became apparent and lingered until VCHCA abandoned its Ventura server farm and switched to Cerner Remote Hosting (RHO) in April 8 Ventura County EHR System Implementation Risks 2015. The new problem was that the “Order Entry” window response time, initially several minutes, was intolerable for most users. One of the causes was system design limitations in the server farm (e.g., the Storage Area Network [SAN] did not have enough ports) due to VCHCA’s underestimating the number of simultaneous users.
No recommendations for this finding
F33
Both VCHCA’s and Cerner’s system administrators managed to speed up response time slightly while the EHR was still hosted in Ventura by adjusting system software parameters. However, they were never able to get response time to acceptable levels. VCHCA decided not to pursue further hardware upgrades to the server farm in Ventura. Instead servers and server support were switched to Kansas City by purchasing Cerner’s RHO option.
No recommendations for this finding
F34
For six months after Go-Live, there were occasional planned and unplanned downtimes when the EHR network would be unavailable. During such intervals clinical staff had to temporarily revert to paper recordkeeping and then enter the paper information into the EHR when it came back online.
No recommendations for this finding
F35
To protect against an outage of the EHR, Cerner has the capability to periodically backup patient records (e.g., medication prescribed/ administered, lab results) “locally” in the hospitals, independent of the central EHR server farm. These backup “724 systems” are read-only to be used for retrieval of recent patient records during a system outage. At Go- Live, these 724 systems had not been configured and activated. After the Go-Live date, over a period of several months, thirty 724 systems were deployed by IT at strategic locations throughout the hospitals.
No recommendations for this finding
F36
The Wi-Fi network at the Ventura County Medical Center was not adequately assessed and tested before Go-Live. The network experienced intermittent problems beginning at Go-Live and for several months thereafter. This condition interfered with staff productivity and led to frustration.
No recommendations for this finding
F37
VCHCA personnel discovered that the standard Cerner-formatted prescription label did not contain all the content/dosage information that the compounding pharmacist and administering nurse needed. This deficiency and many other issues considered high priority by hospital staff were duly reported to the Help Desk and to management as patient care issues. The Pharmacy label format issue was not resolved for nine months.
No recommendations for this finding
F38
Before hardware was ordered, focus groups were used to gauge end-user hardware preferences. At these sessions, selected staff got to view and touch a variety of end-user equipment, but the equipment was not tested in a live environment as it would be used in the hospital. Users did not have an opportunity to evaluate the hardware as it would be used in their normal work environment. For example, tablets were selected as a choice for nurses. But after Go-Live, nurses tried to use them for charting but found they were inappropriate for a variety of reasons (e.g., the charting area was too small with the current Cerner Solutions; the pop-up on-screen Ventura County EHR Implementation Risks 9 keyboard covered valuable chart area; battery life was only a couple of hours). The tablets had to be replaced with alternative hardware. In addition, the laptops with built-in scanners were focus group selected, but in practice with the EHR system they were impractical to use and had to be replaced. [Ref-09]
No recommendations for this finding
F39
The purchase requisitions for end-user hardware needed to support the EHR Go-Live event were forwarded to VCHCA administration in December 2012 by the VCHCA IT organization. But the end-user hardware was not ordered until May-June 2013. Thus a significant amount of equipment was unavailable to be properly configured and in place for staff to use for check-out and refresher training in their work environment before Go-Live.
No recommendations for this finding
F40
Due to inadequate planning, a significant number of workstations and tablets had to be ordered after Go-Live.
No recommendations for this finding
F41
At Go-Live, many of the computer printer assignments were incorrectly configured by IT technicians. Printouts were directed to out-of-area printers that potentially exposed critical data until the default destination printer was located and the printout picked up by the requester. It took many weeks to get all associated printer problems fixed.
No recommendations for this finding
F42
There were EHR Implementation related concerns regarding potential risks due to a variety of factors. Issues of concern included:  Due to the frequent early EHR instability, staff had to temporarily administer medical care without access to recent patient records; they had to fall back to handwritten paper recordkeeping; and then, retroactively, update the EHR when it became accessible again.  Saturation of EHR login capacity led to frequent staff login failure attempts, a condition that went unresolved during the first several weeks after Go-Live.  Frequent crashes of the EHR during first 6 months after Go-Live  Incomplete/inadequate/inconsistent data entry windows, order sentences, and pick-list choices used by physicians, nurses, pharmacists, and other healthcare staff to select from in the various Solution charts  Sluggish response times for users launching/updating Solution window displays  Printer queues (particularly label printers used by the Pharmacy and Labs) frequently stalled and stopped printing labels. Pharmacy staff had to resort to handwriting labels—usually for several hours. On third shift or weekends, IT support was not readily available to fix the blockage. The handwritten labels used to work around EHR outages precluded the automatic checks normally performed by the EHR when verifying correct medication/patient administration. This situation was not resolved for over nine months after Go-Live when IT reconfigured printer servers in the server farm. Ventura County EHR System Implementation Risks
No recommendations for this finding
F43
While there are no reported incidents of harm to patients because of EHR problems, there are documented occasions that potentially could have put patients in danger if alert clinical staff had not taken corrective actions with workarounds.
No recommendations for this finding
F44
During the EHR Implementation, the communication paths within VCHCA’s organizational structure became ambiguous. IT problems involving patient care tended to be reported to IT personnel and may not have reached clinical management.
No recommendations for this finding
F45
Over 50,000 hours of EHR user training was provided over a four-month period to 3,000+ clinicians, ancillary, and support VCHCA staff. Typical training involved 12 to 16 hours of instruction and hands-on training spread over multiple sessions in nine dedicated training rooms. [Ref-05, Ref-09]
No recommendations for this finding
F46
The user training did not include competency testing before Go-Live. It was also noted that training did not satisfactorily address learning retention losses with timely hands-on refresher courses using an EHR domain and more robust training materials. Nor did it adequately stress the importance of accuracy using discipline-specific examples of correct vs. incorrect situations (e.g., data entry accuracy).
No recommendations for this finding
F47
Immediately after EHR Go-Live, many of the VCHCA staff were not comfortable using the system in spite of the training opportunities that had been provided and the availability of experts to help. Many users were confused and frustrated—a situation that was compounded by unplanned system downtime, slow window response time, and frequent failure of login attempts.
No recommendations for this finding
F48
Many factors contributed to patient billing problems associated with the EHR:  Some users did not consistently enter data correctly into Solution windows, which ultimately led to downstream uncollectable patient billing.  Beginning with Go-Live, much of the patient information used for billing by the EHR was not accurate. Many bills produced from the EHR were rejected by the “Scrubber” checking process and simply set aside to be looked at later for diagnosis and correction.  By second quarter 2014, the backlog of unresolved billing produced by the EHR was 9 to 10 months behind, due to rejected claims having incorrect/inconsistent/missing data on patient billing.  After a deep-dive analysis by VCHCA, the rejected claims were found to be due to a variety of problems, most notable being data entry issues such as: o Ineffectual training Ventura County EHR Implementation Risks 11 o Lack of attention by staff entering patient and treatment data into the EHR o Lack of proper supervisory oversight
No recommendations for this finding
F49
Diagnosis of the VCHCA’s billing issues was initially compounded by a variety of problems including:  A backlog of growing rejected billing  A lack of adequate staffing resources to correct the problems  Cerner “canned” report writing applications that produced inadequate visibility into the billing problems  A shortage of skilled staff to quickly develop new and more detailed diagnostic reports from the Cerner database
No recommendations for this finding
F50
Several insurance reimbursement entities such as Medi-Cal, Gold Coast, and private insurance companies limit the length of time allowed between patient treatments or discharge from the hospital until a medical provider submits accurate billing. Following the EHR Go-Live event, a significant portion of VCHCA billing claims had not been corrected within the time limit and were denied payment. As of March 2015, this potentially uncollectable amount may have exceeded millions of dollars. The VCHCA was reported to be in the process of trying to reduce this collections deficit.
No recommendations for this finding
F51
VCHCA successfully met the Stage 1 Meaningful Use requirements:  Both hospitals completed a successful 90-day attestation cycle on September 30, 2013.  148 eligible providers (99%) completed individual 90-day cycles by December 1, 2013. [Ref-09] Findings
No recommendations for this finding

Commendations 2