A Lean Six Sigma Case Study

A Lean Six Sigma Case Study: Medication Reconciliation

Vickie L. Kamataris, RN, MSN, HCSM, CPHQ, LSSMBBE-Squared Performance Partners

1

A Road Less Traveled

2Copyright© 2016 E-Squared Performance Partners All Rights Reserved

What is Medication Reconciliation?

• The goal of Medication Reconciliation is to provide appropriate medications to the patient across all transition points; to prevent adverse drug events (ADEs).

• Medication Reconciliation is complete when each drug the patient is taking has been actively continued, discontinued, held, or modified at each transition point.

• Medication Reconciliation is a three step process:


Medication reconciliation is the process of creating and maintaining the most accurate list possible of all medications a patient is taking - including drug name, dosage, frequency, and route – and using that list to guide medical treatment.

Background


Obtaining a complete and accurate medication history so that treatment decisions can be appropriately made is not a new concept.

Verification is the collection of a medication history.

Clarification is ensuring that medications, dosages, frequency, and route are appropriate.

Reconciliation is documentation of changes in medication orders (continue, discontinue, hold, change).

Transition Points:• Admission• Transfer (to another level of care)• Discharge

Medications:• Prescribed medications• Over-the-counter medications• Alternative, homeopathic, and herbal

medications

Meet Janet


68-year old Janet Doe comes to the Emergency Department for worsening chest pain. Janet has a history of hypertension, gout, diabetes, and asthma.

Meds Janet brought from home:• Some in bottles• Some in zip lock bags• Do not include Over the Counter

(OTC), homeopathic/ alternative meds

On average, Americans aged 65 to 69 take 14 prescription medications.

-Am Society of Consultant Pharmacists

Janet’s Home Meds List


Janet brings her medications to the Emergency Department in zip lock bags:

Morning Ziplock:Allopurinol 50mg 2 Tabs: Take 1 or 2 a dayAspirin ½ TabClopidogrel 75mg TabCochicine 0.6mg TabGlyburide 1.25mg TabAmiloride 5mg TabEnalapril 20mg TabTylenol Arthritis 650mg 2 Tabs

Afternoon Ziplock:Tylenol Arthritis 650mg 2 Tabs

Evening Ziplock:Colchine 0.6mg TabGlyburide 1.25mg TabSimvastin 80mg TabWarfarin 5mg TabAmiloride 5mg TabTylenol Arthritis 650mg 2 Tabs

Fortunately, Janet brought the bottles. Otherwise, each pill would have to be identified individually.

Janet’s Pharmacy Med List


A medication list is obtained from Janet’s Pharmacy:

Allopurinol 100mg daily (2 50mg Tabs)Clopidogrel 75mg po dailyColchicine 0.6mg dailyGlyburide 1.25mg dailyImdur 30mg po daily (not filled X 3 months)Metoprolol XL 50 mg dailySimvastin 80mg po qhsWarfarin 5mg po q pmAmiloride 5mg po bid (not filled > 1 month)Enalapril 20mg bid (not filled > 3 months)Nitro 0.4mg SL prn sobAdvair 250/50mg 1 puff bid (never filled)

Janet’s pharmacist has no way of knowing whether she takes her meds as directed or if Janet uses other pharmacies.

Janet’s PCP (Doctor’s) Med List


A medication list is obtained from Janet’s Primary Care Provider:

Allopurinol 100mg dailyAspirin 162.5 mg po dailyClopidogrel 75mg po dailyGlyburide 1.25mg po bidImdur 30mg po daily Zocor 80mg po q hsCoumadin 5mg po q pmMetoprolol XL 50 mg dailyAmiloride 5mg po bid Enalapril 20mg bid Nitro 0.4mg SL prn sobAlbuterol inhaler prn Advair 250/50mg 1 puff bid

Janet is asked about her medications at (almost) every clinic visit but Janet forgets sometimes and the clinic record is not yet integrated to the system’s EHR.

Janet’s Discharge Med List


Janet was hospitalized six months ago and her discharge medication list is available via the EHR:

Coumadin 7.5mg po q pmAllopurinol 50mg po q dayEnteric coated ASA 325 mg po dailyPlavix 75mg po dailyColchicine 0.6mg po bidGlyburide 1.25mg po bidImdur ER 30mg dailyZocor 80mg po bedtime

Patients discharged from the hospital are given discharge instructions. 65% of patients don’t understand them (Am Journal of Surgery).

Janet’s ‘Complete’ Med List


Janet’s nurse asks her questions to determine what medications, including non-prescription medications , Janet is actually taking. Janet calls her daughter for a list:

GasX 125mg: 1 or 2 as neededPrilosec 20mg: 1 or 2 as neededGaviscon Extra Strength: 1 or 2 as neededMirilax 17g: as neededClaritin D: 1 or 2 as neededAfrin Nasal Spray: as neededOmegaXL: 2 or 3 per day Centrum Silver Women 50+: 1 per day4St. John’s Wort 250mg: 1 or 2 per dayMoon Drops Losenges: As need for sleep

Patients often don’t consider over-the-counter and herbal remedies ‘medications.’

Meanwhile…while all of this is happening…patients wait. Due to Janet’s cardiac history, her ED doctor orders emergent diagnostics and treatments. This creates

risk for the hospital, the doctor, and for Janet.

Context


Experience from hundreds of organizations has shown that poor communication of medical information at transition points is responsible for as many as 50% of all medication errors and up to 20% of adverse drug events.

A study of hospitalized patients identified an average of 5.5 medication errors per patient on

admission and 3.3 errors per patient on discharge. The average American is 10 times more

likely to be hospitalized due to an adverse drug reaction than from a motor vehicle accident.

Properly prescribed drugs cause about 1.9M hospitalizations a year. Each year in the US,

medication errors occur in 3.8M inpatient admissions and 3.3M outpatient visits. 128,000people die from drugs prescribed to them, ranking 4th with stroke as a leading cause of death.

Medical errors rank 3rd, behind heart disease, which is the first, and cancer, which is second.

7,000 people die per year as a result of preventable medication errors. Med Rec errors occur

in all phases of care: 22% during admission, 66% during transitions of care, and 12% at

discharge. Approximately 100 undetected dispensing errors occur every day. Only 4% of

physicians have access to an EMR with a fully functional prescribing function. 420,000hospitalized patients experience an adverse drug reaction or medication error per year; a cost of

more than $200B. 60% of medication error cases result in a jury verdict over $1M. The

median award is $3,539,541.

We’re the Government…


Medication Reconciliation was developed in the mid 2000s as a response to a rising incidence of adverse drug events (ADEs) and the risk for unnecessary (and costly) subsequent care.

Regulatory Requirements:2005: Joint Commission National Patient Safety

Goal (NPSG) #8 2006: JC accredited organizations required to

comply or face penalties2009–2011: Scoring suspended due to a ‘lack of

proven strategies’ 2011: Med Rec was incorporated into NPSG #3 2011: Meaningful Use 170.314(b)(a) requires

Clinical Information Reconciliation

Financial Implications:• Failure to comply with Meaningful Use will result in $600M in penalties in 2016.• Hospital Value-Based Purchasing (HVBP) program redistributed about $140M

from hospitals that received penalties to hospitals that received bonuses in 2015.

A Universal Healthcare Challenge

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• IHI Forum December 2009 -IHI Improvement Map lists Core Healthcare Processes

• Red push pins = most severely broken processes

• Silver push pins = CPI successes

• Med Rec• Only one ‘possible best

practice’ noted: “One Patient: One List”

• Hospitals revert to paper processes : Don’t try it in vapor ‘til you can do it on paper!’

• No helpful hints One hospital’s conclusion: We are not alone! Medication Reconciliation is the right thing to do…

but how?

Copyright© 2016 E-Squared Performance Partners All Rights Reserved

From Parking Lot to Priority

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Because the primary opportunity R/T Medication Reconciliation was defects and because the scope of the problem was LARGE, Med Rec was relegated to the Parking Lot.

Inaugural Lean Events: #1: CHF Discharge#2: Patient Transfer#3: ED Critical Labs#4: Patient Holds

Pareto Analysis of CHF Failures


For three out of four inaugural events, Medication Reconciliation was identified as a significant factor

The Problem

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•Readmission rate = 15.4%•30-60 minutes of re-work per admission to correct Med Rec discrepancies•In a sample of CHF Core Measure HF1d failures (n=68; June 2009), 29.1%were due to Medication Reconciliation discrepancies. From April of 2009 –March 2010, 100% of CHF Core Measure failures were due to MedicationReconciliation errors.

AprFebDecOctAugJunAprFebDecOctAugJunApr

100.00%

90.00%

80.00%

70.00%

60.00%

50.00%

Apr'09-Mar'10 - as of 05/26

Co

mp

osit

e S

co

re

_X=87.46%

LCL=58.55%

Control Chart - Composite Scores (CHF Core Measure)Apr, 2008 - Apr, 2010

Post - VSAPre-VSA

The ProcessVSA had identified and eliminated waste and managed constraints in the CHF Discharge Process. Impressive Results!

…But still not good enough.

The Six Sigma methodology and toolset was needed to reduce variation and to identify and eliminate the root cause of defects…a dilemma for hospital leadership.


The Six Sigma Roadmap

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Define

Measure

Analyze

Improve

Control

Define the problem and what the customer wants

Measure process performance

Analyze the data and discover the cause(s) of the problem

Improve the process to eliminate the causes (Xs) identified

Control the Xs to make sure the problem stays solved

Six Sigma is a disciplined approach to process improvement that utilizes the DMAIC Roadmap. For the Medication Reconciliation the DMAIC Roadmap would provide project framework but tools from many disciplines would be used.


Other tools used: Change Management, Project Management, Lean, Theory of Constraints, and TRIZ

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Medication Reconciliation: Define

• Champion: Vice President of Quality and Patient Safety

• Team Members:

– A Physician Hospitalist

– Nurse Manager, Telemetry Unit

– Staff Nurse, Telemetry Unit

– Department Lead, Clinical Informatics

– Pharmacy Info Analyst

– Nurse Manager, ICU

– Nursing Data Coordinator

– Core Measures Abstractor, HIM

– Pharmacist

– Hospital Money Belt

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Client: Medium-sized (280 beds) urban medical center; university affiliated teaching hospital; regional trauma and referral center


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The Project Charter

Failure to reconcile medications causes adverse drug events, resulting in poor clinical outcomes and readmission. Current readmission rate = 15.4% (2008 and 2009 YTD). Improper documentation of Medication Reconciliation creates re-work: wasting 30 to 60 minutes of nurse and physician time per hospital admission to correct Medication Reconciliation errors. 46% of medication errors occur on admission or discharge. In a sample of CHF Core Measure HF1d failures (n=68; June 2009), 29.1% were due to Medication Reconciliation discrepancies. Since April of 2008, 100% of CHF Core Measure failures have been due to Medication Reconciliation Errors.

Problem Statement

Simplify and Standardize the Medication Reconciliation process, identify and eliminate sources of variation and root causes for defects, reduce non value-added time spent by staff to correct Medication Reconciliation errors and improve compliance with NPSG8 to 100%. To reduce the incidence of Adverse Drug Events (ADEs) and associated readmissions and LOS.

Goal Statement

The Charter served as a contract between hospital leadership, via the Champion sponsor and was the means by which the team was empowered to make change.


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The Project Charter

Scope

In Scope: Medical Centers, Inpatients and Outpatients Assigned to Beds, Family Physicians, SeniorLiving CentersOut of Scope: County Hospitals, Outpatients Unassigned to Beds, other network clinics and nursing homes

The scope of the project was large, involving many disciplines, departments, and entities. For that reason alone (not considering complexity and difficulty and many prior failed attempts to solve the problem), an experienced BB or MBB was needed.

Start Event: Patient admitted to the hospital or PATStop Event: First encounter at next level of care

Process Boundaries


Business Case

Core Measure performance below regional and national benchmarks results in diminished reputation,loss in market share and, in the future, will result in decreased reimbursement under CMS value-basedpurchasing and P4P. Correcting Med Rec errors and redundant documentation diverts provider andstaff time from patient care, diminishing quality of care and patient and provider satisfaction. ADEsresult in readmission and extended LOS, resulting in increased costs and decreased reimbursement

2020

The Project Charter

% Compliance for CHF (HF1) Core MeasureBaseline: 85%Goal: 100%

Project Metrics

Readmission RateBaseline: 15.4%Goal: <12%

LOS on Acute Care UnitsBaseline: 7.4Goal: 5

% Medication Reconciliation ComplianceBaseline: Measurement System TBDGoal: 100%

Project metrics were defined so that the baseline performance gap could be understood and so that improvement could be clearly and convincingly demonstrated. Secondary or control metrics prevented sub-optimization (fixing one thing only to break another).


Note that the primary metric was, initially, a proxy. At this time metrics and measurement systems for Medication Reconciliation had yet to be established. This made it particularly difficult for the leadership team to justify a project of such a large scope (and corresponding expense).

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The Project Charter

Projected Financial Impact

Type I: Under CMS value-based purchasing and P4P, reimbursement will be reduced from 3 to 5 % for Core Measure performance below the national benchmark. Improved Core Measure Performance would result in Type I savings. Reimbursement may be denied or reduced for readmissions within 30 days. In 2008, more than 4000 readmissions would have been affected. Estimated savings = $252,000.00 per year.Type II: Provider and staff time currently wasted due to complexity, redundancy, and the need tocorrect Med Rec discrepancies will be reallocated to patient care. Estimated savings = $75,925.50 peryear.Type III: Simplifying, standardizing, and improving the Med Rec process will improve quality of careby reducing risk for medication errors and improving patient safety. Patient, staff and providersatisfaction will be improved, enhancing reputation and market growth.

Financial benefits are estimated based on operational targets: If Y could be moved from A to B, then $X would be the result. In this case, there were many unknowns and initial estimates were extremely conservative and based on educated guesses.


Recall that, at this time, the Joint Commission requirement for Medication Reconciliation had been suspended. The leadership team struggled to justify the need for the project now. In the end, they decided that it was the right thing to do.

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Pareto Analysis

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In this case, Pareto analysis provided little information to narrow scope or to focus data collection.

No Pareto effect was observed for DRG, admitting or discharging provider or RN, source of admission or discharge destination. Since more than 80% of patients were admitted from home or the ED and most were discharged to home, so these Pareto analyses were not surprises.

Conclusion: Med Rec process is universally broken.

Pareto analyses are used in the Define Phase to refine the scope of the project and to use stratifiers (grouping characteristics such as hospital unit or DRG category) to identify the root cause(s) and focus data collection.


Medication Reconciliation: Define

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A SIPOC focused the team and identified potential Xs and Ys. The SIPOC is also an important means of ensuring that all of the key stakeholders had been included on the project team.


CTQs

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Customer(s) Key Customer Issue(s)Critical

Customer Requirement(s)

Pt/Family Medication Accuracy and SafetyNo ADEs, Understand

Discharge Med Instructions

PCP/Provider Info to Care for PtMed Info is Correct and

Timely

Hospital Compliance, Performance, Cost Core Measure Performance = 100%; Readmission Rate <

Benchmark; Minimal Resources

Interdisciplinary Care Team Effectiveness, Efficiency Info to Provide Care, Confidence in Process, Minimize Re-Work and

Redundancy

Critical to Quality characteristics (CTQs) were identified so that process specifications could be determined. Only then could the gap between customer needs and process performance be quantified. This would establish a baseline for the project.


Define Phase Summary

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•Scope of the project was discussed at the senior leadership level and the risk of an unsuccessful project was determined to exceed the risk of reducing scope and chartering multiple projects (time being the key factor). •A Stakeholder Analysis reinforced the importance of communication and creating buy-in.•A detailed Communication Plan was launched.•The complexity of the process map was discouraging to some members of the team. Simplificationbecame the #1 initial concern. •A ‘best tool for the job’ approach was used to

•Reinforce the value of a comprehensive tool set.•Provide newly trained Lean Experts opportunities to apply learning.•To map the process

•A Functional Process Map to illustrate handoffs.•ProcessVSA to identify waste.•Constraint Analysis to identify bottlenecks.

•Realizing that the IHI had identified Medication Reconciliation as one of healthcare’s toughest problems was both an incentive and a cause for concern.•Some new team members were added as a result of the SIPOC. Many more would be added later.

The purpose of the Define Phase it to minimize the risk of a failed project. This project, for many reasons, had a high risk of failure. Some highlights of the Define Phase:


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Medication Reconciliation: Measure

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Medication Reconciliation Process

The process for reconciling medications was complex, including 94 steps and 24 handoffs between functions. 53% of the activity undertaken to reconcile medications was non value-added (waste!).

The process was full of work-arounds and redundancies. Everyone involved was working hard but the process was severely broken: 78 Steps. 27 Handoffs.


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Sampling and Data Collection Plan

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Measure

Operational

Definition

Collection

Method Source Sampling Actionee DateMeasure

what?

[What units?]

Be specific

(Incl. Query if appl.)

How will data

be collected? Where? How many?

Who will

collect? When?

Med Rec Compliance

CHF Core Measures Definitions Chart

AuditHIM 100 QM Abstractors December

2009

Alternative to IRB ‘Suggested’ Sampling Strategy

• N = 2132 discharges per month• Data Collection Method: Retrospective Chart Audit• Reducing sample size to 100 increases MoE to 9.5%• n = 100• Sample method: random

The hospital had not fully implemented their EMR. Computerized order entry was still a challenge for providers. Med Rec was a paper process on some hospital units and in the clinics. With more than 25,000 admissions per year in 2009, a sampling strategy was needed. Chart audits are a costly and extremely difficult means of collecting data.


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Measurement System Analysis

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The initial Measurement Plan used CHF Core Measures as a proxy for Medication Reconciliation. This Measurement System failed to pass an Attribute Measurement System Analysis (MSA) and a new measurement system incorporating an audit template had to be created, tested and refined. This delayed the project 3 months.

CHF Proxy Med Rec Audit


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Baseline Process Capability

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The Medication Reconciliation process was not capable of meeting customer specifications:

63% of Med Rec Failures: Discharge Med Rec does not match list provided to patient

73% of Med Rec Failures: Discharge Summary does not match discharge Med Rec list

90% of Med Rec Failures: Dictated Discharge Summary does not refer to Med Rec List

37% of Defective Records: Have more than 1 discrepancy

Process Capability

Measure

DPMO 600,000

% Defect 60

% Yield 40

Process Sigma -.253

Once the Measurement System was validated, the capability of the process to meet customer specifications could finally be determined. It was worse than feared! The Charter was revised to reflect the new baseline.


Measure Phase Summary

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•Process capability could not be adequately assessed using the CHF Core Measure proxy

•Chart audits are a resource intensive means of collecting data (30 minutes per chart)

•A reasonable sampling plan (balance of power and cost of data collection) was formulated using Minitab

•Measure Phase takes longer than expected when good data is not readily available

•A Measurement Plan •Included detailed instructions for chart auditors•Provided templates for data collection, aggregation, and reporting•Clearly and concisely defined all key terms•Resulted in a 100% acceptable Measurement System

The Measure Phase characterized the process using process flow mapping and descriptive statistics, validated the trustworthiness of the Measurement System, and established baseline process capability.


Medication Reconciliation: Analyze

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An Ishikawa or Fishbone Diagram was used to brainstorm and capture potential causes of Medication Reconciliation noncompliance.


One Score

Potential Xs

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•Potential Xs for Med Rec included :•Admitting Unit•Disposition Destination•Patient Care Unit•Admitting Nurse•Discharging Nurse•Step in the Process

Trivial Xs were distinguished from Critical Xs using Chi Square and Regression Analysis. There were (as always) some surprises!

Y = f (x1, x2,…, xn)

•Number of Prescribing Providers•Therapeutic Interchange•Inpatient or Outpatient Status•Resident Involvement in Care•Number of Home Meds•High-risk Meds

Six Sigma translates a practical problem into a statistical problem and then a statistical solution into a practical solution. In the Analyze Phase, the Xs having the greatest impact on the Y were identified.


Hypothesis Test Summary

Hypothesis Test (ANOVA, 1 or 2 sample t-test, Chi

Squared, Test of Equal Variance, etc.)

FactorTested

P-Value

Conclusion

Chi Square Inpatient/Outpatient Status >.05Patient status (inpatient versus outpatient) does not

affect Medication Reconciliation compliance.

Chi Square Hospitalist Oversight <.05Oversight by a hospitalist has a significant positive impact on Medication Reconciliation compliance.

Chi Square Resident Care >.05Resident care of the patient does not have a statistically significant impact on Medication

Reconciliation compliance.

Chi Square Admission Source >.05Where the patient is admitted from does not affect

Medication Reconciliation compliance.

Chi Square Disposition >.05Where the patient is discharged to does not affect

Medication Reconciliation compliance.

Chi Square Therapeutic Interchange >.05Therapeutic Interchange does not affect Medication

Reconciliation compliance

Regression Analysis Number of Home meds <.05*Number of home meds has a negative correlation

with Medication Reconciliation compliance

Regression AnalysisNumber of physician

Providers>.05* Number of providers prescribing medications has no

correlation with Medication Reconciliation compliance

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*R-Sq for Multiple Regression Analysis = 93.7%R-Sq(ajd) = 93.5%

Hypothesis testing was used to determine, statistically, whether each X had a significant impact on the Y (in this case, Med Rec compliance).


Analyze Phase Summary

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Critical Xs identified:•Complexity (number of steps, handoffs, roles involved)•Multiple redundancies and ‘stop gap’ measures•Lack of clear ownership and accountability•Measurement gaps•Number of home meds•Hospitalist oversight – how does their process differ??

Some findings were expected based on benchmarks•Number of home meds•High risk meds

Some findings were complete surprises! Both Xs that were and Xs that were not statistically significant factors in Med Rec compliance

The factors impacting Medication Reconciliation compliance were Process not People factors (with the exception of a happy hospitalist who was quite pleased to learn that ‘his’ p value was 0.000).

The deliverable of the Analyze Phase is a list of critical Xs. The process would be re-designed in the Improve Phase to eliminate or mitigate those Xs.


Medication Reconciliation: Improve

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The team benchmarked the literature and best practices to develop a list of design characteristics for the new process. Benchmarks included the Mayo Clinic, Sisters of St. Joseph, Missouri Baptist Medical Center, Catholic Healthcare Partners, US Navy Medicine, Johns Hopkins University Hospital, Fairview Health Services, Emory University School of Medicine, IHI, Taranaki Base Hospital, and Vanderbilt University.

0 100 200 300

One Med Rec List

Captain of the Ship

Dr Entry of Discharge MedRec

Admit RN or Pharm Entry ofAdmit Med Rec

Independent of RNExpertise

NexGen and Meds ConnectAccess by PCP

Group Meds by Category

Admit Med Rec Tollgate

Pt Arrives at Hospital withMed Rec

Process Redesign PrioritiesQuality Function Deployment


Hospitalist?

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A hospitalist is a physician dedicated to care in the inpatient setting. In this case, only 3 of 10 units had hospitalists as part of a pilot program. It was suspected (by non-hospitalist attendings) that the rate of Med Rec errors would be higher, so this was a surprise!


The team created a survey that a sample of hospitalists and non-hospitalist attending physicians completed. The difference was quickly obvious but even the team was skeptical so a focus group was used to validate survey results:• Hospitalists assume they don’t know what

medications the patient is taking. “We assume we don’t know and start from scratch with every patient.”

• Attending physicians who provided care to hospitalized patients outside the hospital assumed they knew ‘most’ of the medications their patients are taking.

Development of the Future State

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The process for reconciling medications remains complex and requires many handoffs between functions. These are now mostly electronic. Two new functional roles were added. Redundant activities were eliminated and non value-added activity was reduced from 53% to 5%.

The team used the results of Analyze, best practices from benchmarking, analysis of the hospitalist role, and design specifications developed from the FMEA and QFD to create a Future State designed to consistently achieve 100% Med Rec. Note that not all waste could be removed within the project period and that steps were added.


Plan of Action

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•Pre-Admit•Clarifications•System Improvements/Enhancements•Discharge

Quick Hit Improvements that required no further analysis were completed immediately.

More complex improvements required additional work (and time) to design and develop:1. Create, with patients, EMS and clinic partners, a home medication list 2. Define the competencies of the Admission Med Rec Specialist3. Develop the criteria for a Complex Medication Profile4. Develop ONE electronic and paper form for Medication Reconciliation5. Define the role of Discharge Pharmacist6. Define the specifications for necessary systems changes/enhancements

To achieve the Future State, an Action Plan was developed. A Solution Selection Matrix was used to prioritize solutions. It was divided into four categories:


Quick Hit Improvements

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Admission:•Pharmacy to receive admission Med Reconciliation from PAT immediately•Admit tollgate for Med Reconciliation•Laminated photos of medications for patients•Providers take the hospitalist approach, assume you don’t know.

Clarification:•Admit Med Reconciliation to be included in EMR Nursing Assessment Status ‘C’ for Complete or ‘P’ for Pending

System:•ED system transmits admission Med Reconciliation to inpatient EMR•Additional printers for discharge medication lists and instructions•Last dose and time fields populated from MAK (Medication Administration Checking) system

Discharge: •Auto fax discharge medication list to next point of care•Providers and nurses complete discharge Med Reconciliation electronically


Many Quick Hit or Just Do It improvements were implemented. Just Do It did not mean it was easy or that it happened without management involvement. Training, communication, cost benefit analysis and budgeting were necessary. Some highlights:

Failure Modes and Effects Analysis


A Failure Modes and Effects Analysis was completed to assess and mitigate risk associated with the newly designed process. This is critical for a clinical process where the consequences of failure are far greater than ‘scrap.’

The highest ‘Severity’ scores and the highest Risk Priority Numbers:• List for the wrong patient• Home meds unknown/unavailable• Admission status critical• Patient level of consciousness• Patient noncompliant• Patient discharged before

pharmacist review• Med Rec specialist unavailable

(staffing)

Process controls were designed for any Severity > 8 and any RPN > 480 with additional process steps put on a ‘watch’ list.

Test of Change #1

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Test of Change #1:Only 14 patients meeting the criteria for Complex Medication Profile were admitted to the care of a hospitalist on the Test unit. The Med Rec Specialist was able to closely monitor all applicable patients and there were no discrepancies noted in the test population but many lessons learned:

•System issues created some delays. •Access was a problem.•One patient was transferred in and the Med Rec Specialist was not notified.•Nurses report that it takes time to assist Physicians with the new form.•Residents want to be involved.

Positive feedback from the staff:

“It’s the first time a committee has ever done anything that actually makes it easier for the nurse to take care of patients.”

“OK…so this is easier than the old way. I didn’t expect that!”

A Test of Change was designed to pilot the new process. Due to the involvement of multiple physicians and the risk involved in medication administration, the initial Test of Change was limited to one Patient Care Unit and was closely monitored by the team to ensure patient safety.


Test of Change #2

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A subsequent Test of Change was designed to pilot the new process on two busy telemetry units. The units were selected because patients were likely to meet the criteria for Complex Medication Profile and census was expected to be high.

The Results:

Leadership was convinced that the new process was a significant improvement…but…

Process Capability

Measure Improve

DPMO 600,000 DPMO 127,660

% Defect 60 % Defect 12.77

% Yield 40 % Yield 87.23

Process Sigma -.253 Process Sigma 1.13


A New Challenge

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The team was directed to find a low-cost (a.k.a. no cost) solution that did not require any additional resources, especially additional staff .

The team was determined that the best solution had been developed and refusing to give up, they struggled to come up with a way to ensure that the cost of implementing the changes necessary to improve Medication Reconciliation would be less than the project was projected to save. It worked!! More details on how later…

Hospital Leadership agreed to move forward with a Phased Implementation beginning in early 2011 and completed in 2012.


Improve Phase Summary

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• Some improvements were easy. Others took time and effort to develop.

• Tests of Change were critical to pilot process improvements and reduce resistance to change. Lessons learned were incorporated into the Future State.

• Even the best solution risks failure to implement in this time of cost consciousness and near-sighted resource constraints

• Keys to Success:• A dedicated physician Champion• An energized and enthusiastic team• Rock-solid data and analysis• Persistence in the face of opposition and delays• Support and involvement of key stakeholders (Hospitalist, Director of Pharmacy)• Thinking outside the box

In the Improve Phase, process improvements were developed, tested and refined. This project was further delayed when leadership decided that a low-cost alternative to the team’s Future State design was needed.


Medication Reconciliation: Control

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Operational Results:•Improved Medication Reconciliation compliance from 40% to 87%•Reallocated 45 minutes of NVA activity per discharge (~1800 hours per year)•Reduced readmissions by 28 cases per year•Increased Core Measure scores for CHF and AMI•Increased reimbursement and P4P•Improved patient and physician satisfaction

Financial Results:• $1.6M in Type I Savings• Net financial benefit = $1.3M• Costs of implementation

•Software upgrades•Personnel

Medication Reconciliation

Once the plan of action was fully implemented and post-improvement process capability was established, Control and Response Plans were developed to ensure that process improvements would be sustained.


Statistical Process Control

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Statistical Process Control (SPC) demonstrated a marked improvement in % compliance (measured by monthly chart audits) before/after the first phase of improvements and again after the final implementation.

Once the project was closed, the process owners continued to monitor performance even after the process was fully automated by the EMR. An EMR does not guarantee Med Rec compliance. In fact, this project illustrates the importance of improving the process before implementing technology to support it!


Control Phase Summary

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Control Plan Elements:• Compare compliance across units (implementing versus not yet implementing)• Data collection and reporting identical to Test of Change 2• Utilize Statistical Process Control for each unit implementing• Report process capability to executive leadership monthly• Link Medication Reconciliation to the developing Balanced Scorecard

Next Steps:• Replicate improvements at county hospitals and extend to other physician

practices and clinics in the network• Re-visit process when the EMR is fully functional, incorporating lessons-

learned into roll-out specifications

Deliverables of the Control Phase include a hand-off of the project to the process owner. This large-scale project took more than a year to complete and was monitored for an additional year as process improvements were rolled out across the system.



Departures From the Roadmap


Remember that this client has initiated a Lean-only deployment. There were trained ‘Lean Specialists’ available but no trained Six Sigma resources except me and I was only on location only once or twice a month.

Departures From the Roadmap

Departures from the DMAIC Roadmap:

Departure #1: Cross-functional VSM formatDeparture #2: Use TRIZ Principle #1 to reduce

the cost of improvementsDeparture #3: Use Lean Rapid Improvement

Events to design key process improvements

Departure #4: Use Lean 5S to improve and standardize the Med Rec form

Departure #5: Use TOC Evaporating Cloud to break the constraint: need to spend money to save money


Purists among you will have noted that the VSMs on slides 18 and 32 are not

the traditional VSM format used in Lean. Because transition points were THEprimary opportunity for failure, the swim lane map was used instead.

Cross-Functional VSM

The traditional VSM above is useful in healthcare but only at a very high level. It does not show the complexity of a cross-functional, multidisciplinary process. The swim lane format highlights handoffs (when the line crosses from one lane to another) and provides visualization and a measure of this critical factor.


I began using Functional or Swim Lane Process Flow Maps as a basis for Value Stream Analysis in 1999 when I realized that the complexity of a multi-disciplinary process could not be understood using a traditional VSM.

Cross-Functional VSM

NOVACES first published this approach for transactional processes in 2012. The details are available in the book, Performance Improvement for Healthcare


The cost of applying all the process improvements to every admission, transfer, and discharge (25,000 admissions in 2009) would have exceeded $5M per year. Some means of segregating the most at-risk patients was needed.

TRIZ: Complex Med Profile

TRIZ, теория решения изобретательских задач, the Theory of Inventive Problem-Solving, is derived from generalizable patterns of invention in the global patent literature and was developed by the Soviet inventor, Genrich Altshuller.

TRIZ Fundamentals:• Somebody, sometime, somewhere has

already solved your problem or one similar to it. Creativity means finding that solution and adapting it to your current problem.

• Don’t accept contradictions, resolve them!

The team used TRIZ Principle #1: Segmentation to narrow the scope of the most costly improvements to 21.8% of admitted patients. Only those patients with a Complex Medication Profile would receive the highest level of intervention.

TRIZ Tools:• 40 Principles of Invention• Contradiction Matrix• Ideality/Ideal Final Result/Ideality• Smart Little People• Functional Analysis and Trimming• 76 Standard Solutions


I was discouraged to find that very little was accomplished in the intervals between site visits. Newly trained Lean Experts did not see an alternative to hand-holding in a Six Sigma DMAIC project of this scope.

Lean RIW: Several Key Improvements

A Rapid Improvement Workshop (RIW), Event (RIE) or Kaizen is used to create and implement solutions when the cause(s) are known. In this case, the solutions were known but the how was not known…a perfect opportunity!

RIWs Chartered:• Home Med List Refrigerator Magnet• Complex Med Profile• Role of the Med Rec Specialist• Role of the Discharge Pharmacist• Design Specs for EMR enhancements• Simplified pharmacy process

Why RIWs worked:• Chartering the events created structure and

accountability (Workplan and Champion)• SMEs not on the DMAIC team were needed• Scope, goals, objectives, and timelines were

clear; the RIW structure was familiar


Several versions of the form (both paper and electronic) existed and none were used consistently. Several 5S events had been completed in the hospital system with much publicized results. While discussing the form problem, a team member said (in jest), “Sounds like we need a 5S!”

5S for the Med Rec Form

5S is a fundamental Lean toolset intended to create a Visual Workplace, where there is a place for everything and everything is in its place.

So how did the team adapt a toolset used to create a visual workspace to simplifying a paper and electronic form…

The 5S Method:Sort: The necessary from the unnecessaryStraighten: Arrange for efficient flowSweep (or Shine): Clean the work area and make it visualStandardize: Set standardsSustain: Create controls such as audits and checklists


The team took some license with the 5S method to accomplish the objective: One form (paper and electronic) that would be used everywhere by everyone in the same way every time.

5S for the Med Rec Form

Sort: All of the versions of the form were printed and team members highlighted the unnecessary (pink opposed to red tags)Straighten: The resulting necessary elements were organized in a way that was easy for users:• Brand name and generic linked• Meds grouped by therapeutic category• Separate sections for scheduled and PRN meds• Wasted space eliminated (print fewer pages)

Sweep/Shine: Visual controls were implemented• Home meds and in-house meds in different font• Visual flags for therapeutic interchanges, combination

drugs, and clarification needed• Visual cues for process status (complete, incomplete,

clarification needed, etc.)


Once the paper form was re-designed and validated by stakeholders, the team met with IT to incorporate the changes into the electronic format. Finally, a form was created that looked and worked the same on paper or the computer.

5S for the Med Rec Form (cont.)

Standardize: Poke Yoke and Standard Work were applied to mistake-proof the form • Selection of ‘Complete’ if dose, route, or frequency

was disallowed in the EMR• ‘Wrong’ was made obvious (checkboxes, etc,)• Hard stop on orders missing information• Standard Work was created for all critical tasks

Sustain: Controls ensure that improvements are systematized and continuously improved• SMART metrics (% forms complete, % errors, etc.)• Auditing process, checklist and standardized report• Periodic revisits as phased roll-out reveals new

opportunities and ideas for improvement


ToC Evaporating CloudIn spite of impressive results from the Test of Change, hospital leadership decided that the only acceptable solution was a ‘no cost’ solution. The team felt the hospital needed to ‘spend money to save money,” a classic conflict!!

The Evaporating Cloud (a.k.a Conflict Resolution Diagram) is one of the six Thinking Processes of Theory of Constraints. It’s used to solve a problem for which there seems to be no solution. A: Medication Reconciliation Compliance = the objectiveB: Being Responsive and C: Being Responsible are the needs expressed by hospital leadershipD: Spend money and E: Save money

Conflict: Have to spend money to save moneySolution: Spend a LOT less money than you make!!

Objective: ‘vaporize’ difficult problems by resolving underlying

conflicts

The hospital pharmacy would fill discharge prescriptions resulting in new revenues of more than $1.6M per year and increasing the net return on investment to $1.3M

E


Some CaveatsThis project was highly successful. Compliance was further improved when the EMR was fully implemented in 2012. Paper forms (for network patients) were virtually eliminated. The processes created were used to provide design specifications to the EMR implementation team. Remember…don’t do it in vapor til you can do it on paper!!

But…• The improvements made in this hospital can not

be applied as a template in any other. Each organization is unique. This is why ‘tactics’ don’t work.

• This project took more than a year to complete and another to fully implement. Perseverance (team) and patience (leadership) was necessary.

• Discrepancies continue to be found. The purpose of the process is to reconcile discrepancies, not totally eliminate them. People will be people and thus Clinicians need to be clinicians.


Key Take-AwaysSince this project was completed, many organizations, including IHI, have published guidelines for improving medication reconciliation compliance. While this project predates those guidelines, many of the improvements the team made and the lessons they learned have been published as best practices.

The MARQUIS guide was released by the Society of Hospital Medicine in 2014. MARQUIS (Multi-Center Medication Reconciliation Improvement Study) was funded by an AHRQ grant and is (in my opinion) the best current resource on Medication Reconciliation.

www.hospitalmedicine.org/MARQUIS

What do you think some of the best practices were?

http://www.hospitalmedicine.org/MARQUIS

Conclusion

Questions?


Documents

A Lean Six Sigma Case Study