Improve Tech Pre Calibration Project Book

DMAIC Project Report

Please Select Belt Type:

Project Title: Improve Technetium Pre-calibration

Project Number (1st, 2nd, 3rd…): 2nd

Instantis Project ID#:

Project Leader Name: Ramesh Rajan

Project Leader Job Title: Process Engineer

Segment/GBU/Division/Plant/Region:Imaging Solutions/Nuclear Pharmacy Operations

DMAIC GBDMAIC BB

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Executive SummaryThe Nuclear pharmacy network comprises 1/3 of the total Imaging division revenue. Technetium-99 is a primary radioactive isotope which is used for various diagnostic procedures at hospitals, imaging centers etc. This represents 80% of the pharmacy product portfolio. The product has an extremely short shelf life; a 6 hour half-life and hence is critical that it be used efficiently and in the most cost-effective manner. The pre-calibration time of the product is time elapsed between when the product was dispensed to the time it was used for the intended application.

Currently significant amount of Tc-99 was decaying at the customer site (>6hrs). Historical data showed pre-calibration time for Tech products averaging at approx 8 hours. This represents significant product decay and lost revenue to the pharmacy network. There was also a large degree of inconsistency in pharmacies adhering to Pre-calibration policies with their customer base.

The goal of the project was to improve the pre-calibration time on Technetium base products. Data collection was carried out by developing query language which helped in presenting accurate data that gave high visibility to this project.

Through the use of the DMAIC methodology this project used tools such as VOC, FMEA, Hypothesis test that focused primarily in improving the pre-calibration times for Tech based products by implementation of the following:

- Revenue stream programming change to charge activity beyond the 6 hour pre-cal limit -Customer letter from marketing addressing the goal to maximize the availability of technetium 99m (Tc 99m) for patients, using as much as possible in procedures rather than allowing it to decay on the shelf. These new policies would be designed to encourage unit dose customers use a more “just in time” approach.

- Sales rep training on the Tc conservation program to help facilitate in changing customer behavior; i.e. Move orders to later scheduled runs. To promote lower pre-calibration times, Covidien will charge for pre-calibration activity beyond six hours, new charges will be based on bulk Tc-99 pricing. Bulk Tc-99 will be calibrated for actual delivery time, unless customer chooses to pay for additional activity

Annual impact estimated from this project is $3million/year. Results taken after program launch in Oct 09 shows savings of $300K validate the projected revenue.

The final metrics for the project are as follows:

Name of Metric Baseline Goal Actual(A)-Oct09 Pre-calibration time 8.15 6.0 7.15

.

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Define

Project Charter

Operational Excellence – Team Charter

Program Name: Improve Tech Pre-calibration Total Savings Identified ($ value)

$3 Million/yr

Team Leader: Ramesh Rajan Team Champion: Dave Becker Product or Service Impacted Nuclear Pharmacies Business Unit: Imaging Solutions MBB:

Start Date: April 2009 Target Completion Date: October 2009 Element Description Team Charter

1. Process: The process in which the opportunity exists.

The pharmacy network holds significant improvement opportunities in reducing length of pre-calibration time on technetium based unit dose products and calibrating bulk doses at their delivery time.

2. Problem Description:

Describe the problem that needs to be solved, or the opportunity to be addressed.

Currently significant amount of Technetium 99 is decaying at the customer site which results in product waste and lost revenue. Global moly shortage severely impacts product availability.

3. Objective: What improvement is targeted? Reduction in Tech pre-calibration time would yield significant cost reduction to the pharmacy business. In addition it will improve product availability and increase patient access to Tc99 products. Saved Technetium could be sold at favorable price to a customer.

Name of Metric

Baseline Goal Entitlement* Units of Measure

Precalibration time

8.15 6.0 Hours

4. Metrics: What are the measurements that quantify program progress and success? *What is the best the process is

expected to produce?

Cost Reduction

Cost Avoidance

WIP/ Inventory Reduction

Cash Flow

Labor Savings

Inc. Sales

5. Business Results:

What is the improvement in business performance? Please list any other improvements on a separate sheet as needed.

X X

Included Excluded 6. Program Scope: Which parts of our business processes will be considered? Which customer segments, organizations, geographies, and timeframe?

The project will focus on all Technetium based products which represent 80% of a customer product portfolio.

All other products

7. Team Members: Names and roles of team members

Ramesh Rajan, Dave Becker ,Jeanne Landers, Terese Lafeber, Carolyn Samra, Andy Farrow, Brian Courtney, Pharmacy Regional Managers.

8. Benefit to External Customers:

Who are the final customers, what are their most critical requirements/measurements, and what benefits do we expect to deliver to them?

Reduction in pre-calibration time will reduce cost, improve product availability to external customer and help mitigate the global moly shortage issue. In addition it will allow greater patient access to the product.

Key Project Dates Project Start April 2009 Define Complete May 2009 Measure Complete July 2009 Analyze Complete August 2009 Improve Complete September 2009

8. Schedule: Give the key milestones and dates.

Control Complete October 2009

9. Budget: What financial resources are required for the team?

$5000 for TRON programming.

10. Support Required: Do you anticipate the need for any special capabilities, hardware, trials, etc.?

IS programming, TRON user training, customer communications.

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document.docSIPOC Map

A SIPOC diagram was generated to provide a high level view of the Tech pre-calibration process. This tool helped the team to understand important inputs and outputs to the process.

SUPPLIER INPUT PROCESS OUTPUT CUSTOMER

Customer(Hospital, Independent)

Standing, Demand Orders,TRON

Pharmacy receives customer order for Tech dose with requested delivery and

calibration time

Presciption Customer-Hospital, Independent user

Pharmacist ,Technician Customer Order Dispense dose with activity related to calibration time

Dispensed dose Customer-Hospital

Pharmacy Bill of Lading, TRONTech dose is ship confirmed

and taken for delivery Shipconfirmed Dose Courier

Pharmacy Driver , Bill of LadingDose is delivered to customer

at requested delivery timeDelivered dose Customer-Hospital

Pharmacy Dose charges Pharmacy bills customer for dose includes freight charge.

Customer Invoice Customer

Customer(Hospital, Independent)

Customer Invoice Pharmacy collects sales revenue from dose sale

Sales Revenue Pharmacy

Voice of the Customer/Business

The team also undertook a brainstorming exercise to come up with key customer requirements. This “Voice of Customer” exercise showed the key outputs for the project .These outputs influence the end customer (i.e. hospitals etc) in maintaining reliable and quality supply. At the same time they also affect the pharmacies which are an internal customer as it will help in reducing product decay and capture lost revenue due to excessive pre-calibration.

Limit Precalibratiion time compared to current practice to save Tech waste Mimimize bulk dose waste by shrinking calibration limits Maintain accurate delivery time in TRON

Maintain ontime supply of Tech product to customerNeed more Technetium due to global "Moly" shortageMinimize product shortage

Develop efficient production schedule at pharmacy Maintain efficient delivery routing for customer profile

Reduce Tc Pre-calibration

On Time Delivery

Efficient

Voice of the Customer

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Project Y’s (KPOV’s)

At the end of the Define Phase the team decided to focus on reducing the pre-calibration time on Technetium products as the key Output (Big Y). This would be achieved while still meeting product demand and delivery expectations. Key Process Output Variable

Reduce Precalibration time on Technetium based products

Other Important Factors Maintain product supply as per customer demand Meet customer delivery schedules

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Measure

Process Map

A flowchart was developed to show the sequence and flow in the pre-calibration process. Using this, the teams were able to breakdown and understand the intermediate steps and determine inputs and outputs for each major step.

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document.docCause and Effects Matrix

In order to prioritize the input variables affecting the output requiring improvement, the team used a Cause and Effect (C&E) matrix. A Pareto was also done on the top raking critical inputs from the C&E with a cut-off of 200. This tool helped to focus on the few critical inputs which affect the output.

Rating of Importance to Customer

9 10 8 9

1 2 3 4

On

Tim

e D

eliv

erie

s

Req

uest

ed A

ctiv

ity a

t cal

ibra

tion

time

Dro

ps p

er D

eliv

ery

Ava

ilabi

lity

of T

ech

prod

ucts

TotalProcess Step Process Input

1Pharmacy receives customer order

Calibration,delivery time, calibration policy,Customer communication

9 9 3 9 276

6Pharmacy negotiates existing contracts, communicates changes

Calibration policy, Customer contract, Communication

3 9 9 9 270

2Dose Dispensed with activity related to calibration time

Customer Order,TRON, Calibration,Dely time

3 9 3 9 222

3Tech dose ship confirmed and ready for delivery

Dispensed dose, BOL 9 9 3 0 195

4Dose delivered to customer at requested delivery and calibration time

Dose, BOL, Driver 9 9 3 0 195

5Pharmacy bills customer and collects revenue from dose sale

Sales Invoice, Freight Bill 1 9 9 1 180

00

Total 306

540

240

252

Lower Spec

Target

Upper Spec

Cause and Effect Matrix

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Pareto of C&E matrix

FMEA

The FMEA focused on specific process failures that would affect the Tech pre-calibration process and which would cause product decay and lost revenue. A RPN cut-off of 300 was established by the team for taking the critical inputs coming out of the FMEA into the Analyze phase.

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Pareto of FMEA

Count 1123 616 384 336 72Percent 44.4 24.3 15.2 13.3 2.8Cum % 44.4 68.7 83.9 97.2 100.0

Potential Failure Mode

Other

No adh

eren

ce to

policy

Miscom

mun

icaito

n or

lack

of s

tand

ardiz

ed p

olicy

Inac

curate

deli

very ti

me

Exce

ssive

pre

calibra

tion

2500

2000

1500

1000

500

0

100

80

60

40

20

0

Count

Perc

ent

Pareto of FMEA RPN

The key inputs from the FMEA were Calibration time, Delivery time, Customer contracts and TRON.

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document.docGage R&R

Data collection for the Measure phase was obtained from queries generated from the TRON system A Gage R&R study was then conducted to test the precision of the measurement system and this was done with the help of 2 operators on the critical metric; Average pre-calibration time.

A Gage R&R review showed the variation due to repeatability and reproducibility to be at 3% and part-to part variation at 99% which showed the measurement system was very accurate.

Gage R&R for Over 6 hr precalibration time

Gage R&R Study - ANOVA Method

Two-Way ANOVA Table with Interaction

Source DF SS MS F PSample 34 95.0457 2.79546 3007.40 0.000Operator 1 0.0037 0.00370 3.98 0.054Sample * Operator 34 0.0316 0.00093 * *Repeatability 70 0.0000 0.00000Total 139 95.0810

Alpha to remove interaction term = 0.25

Gage R&R

%ContributionSource VarComp (of VarComp)Total Gage R&R 0.000504 0.07 Repeatability 0.000000 0.00 Reproducibility 0.000504 0.07 Operator 0.000040 0.01 Operator*Sample 0.000465 0.07Part-To-Part 0.698633 99.93Total Variation 0.699137 100.00

Study Var %Study VarSource StdDev (SD) (6 * SD) (%SV)Total Gage R&R 0.022457 0.13474 2.69 Repeatability 0.000000 0.00000 0.00 Reproducibility 0.022457 0.13474 2.69 Operator 0.006288 0.03773 0.75 Operator*Sample 0.021558 0.12935 2.58Part-To-Part 0.835843 5.01506 99.96Total Variation 0.836144 5.01687 100.00

Number of Distinct Categories = 52

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Data NormalityData was collected on average pre- time calibration by pharmacy for June09 and it showed it was normal.

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Process Capability

343128252219161310741

10.0

7.5

5.0

Indiv

idual V

alu

e

_X=8.151

UCL=10.669

LCL=5.633

343128252219161310741

3.0

1.5

0.0

Movin

g R

ange

__MR=0.947

UCL=3.093

LCL=0

3530252015

9

8

7

Observation

Valu

es

9.07.56.04.53.01.50.0

LSL USL

LSL 0USL 6

Specifications

10.07.55.0

Within

Overall

Specs

StDev 0.839367Cp 1.19Cpk -0.85

WithinStDev 0.838408Pp 1.19Ppk -0.86Cpm *

Overall

Process Capability Sixpack of Average precal time JuneI Chart

Moving Range Chart

Last 25 Observations

Capability Histogram

Normal Prob PlotAD: 0.180, P: 0.910

Capability Plot

For the process capability calculations, the lower Specification limit was chosen as 0 hours and the upper limit was taken at 6 hours. The Cpk value of - 0.85 shows that the process capability is less than favorable and there is vast scope for improvement.

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Data Collection

Data collection for the Measure phase was collected from TRON queries that measured the average pre-calibration time across the pharmacy network for June09. This was taken as the baseline.

For this project the Average pre-calibration time is taken as the (Y). The pre-calibration time is defined as the time elapsed between the expected delivery time of the product and its calibration time.

Baseline Measurements Jun-09

Pharmacy Average Time over Delivery time( Bulks) Average Precalibration time June

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Ft Lauderdale 5.12 7.87Crestwood 5.00 9.60Kansas 2.00 7.95Chicago 3.00 7.87St Louis 6.25 6.98Orlando 3.00 8.98St Pete 3.00 7.87Miami 4.00 9.04Memphis 0.00 10.00Atlanta 5.00 8.81Boston 3.00 6.62Wilkesbarre 3.00 7.12Milford 3.00 7.41Pinebrook 3.00 7.21Hicksville 3.00 8.11Hariisburg 4.00 7.80Bethlehem 4.00 7.43Altoona 4.25 7.38Philadephia 3.00 8.10

Dallas 4.00 9.20Los Angeles 3.00 7.52Loma Linda 2.00 8.24San Francisco 3.00 7.68St Paul 3.00 9.50Portland 4.00 8.34Denver 3.00 8.12Houston 3.00 8.46Saginaw 2.15 7.62Toledo 3.00 8.85Colombus 3.00 6.65Dayton 2.00 8.56Detroit 3.00 8.66Beltsville 3.00 8.67Cleveland 3.00 9.25Pittsburgh 3.00 7.81

Average 3.25 8.15

Baseline Metrics

From the data collected in June09 the report showed the following baselines

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Savings Summary

Tc-99 Conservation PlanAnnual Summary Impact

Bulk PrecalBeltsville 201,617 24,697 Cleveland 182,709 21,821 Hicksville 136,829 47,663 Pinebrook 165,864 6,599 Dallas 141,738 39,835 Los Angeles 142,937 4,037 St Pete 148,092 9,581 Denver 124,645 4,459 Orlando 107,840 13,175 Pittsburgh 81,113 52,328 Crestwood 107,076 34,832 St Paul 95,212 12,132 Boston 113,921 4,489 Harriburg 80,833 5,568 Detroit 73,360 3,802 Chicago 66,786 5,666 Milford 63,819 776 Dayton 38,784 6,496 Altoona 71,915 15,905 Wilkes Barre 60,352 3,273 St Louis 53,632 8,019 Bethlehem 63,835 4,635 Houston 25,771 2,203 Ft Lauderdale 54,235 5,967 Colombus 33,115 14,977 Philadelphia 45,994 5,390 Atlanta 40,616 5,900 Portland 21,396 3,756 San Francisco 27,539 4,327 toledo 22,373 5,967 Kansas City 20,967 6,968 Saginaw 23,145 1,298 Miami 29,064 7,046 Loma Linda 10,599 11,210 Cinci 9,582 1,516 Memphis - 5,151

$2,687,299 $411,461

Bulk = All doses sold as Bulk calibrated at expected delivery time

Precal = All unit doses which exceed a 6 hour window between expected delivery and calibration time

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Analyze

Basic Statistics

Basic statistics were gathered on the key output to determine stability and shape. Normality test was also done on the key output which showed data as a normal curve.

The Mean of the data was 8.15 hours while the median is 8.09 which indicate both are very close to each other.

Descriptive Statistics: Average precal time June

Variable N N* Mean SE Mean StDev Minimum Q1 MedianAverage precal time June 35 0 8.151 0.142 0.838 6.621 7.523 8.099

Variable Q3 MaximumAverage precal time June 8.814 10.000

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Graphical Analysis

Box plot of Pre-calibration time by pharmacy showed there exists a difference between means of data between pharmacies of different size. The pre-calibration time variation among pharmacies showed there was a lack of standardized policy related to pre-calibration time. The frequency graph shows historically there have been excessive pre-calibration times practiced at multiple sites with times extending as far as midnight which accounts for substantial product decay and lost revenue.

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Hypothesis Testing

Regression

A Regression analysis was performed with the Key input variables and the Key output variable. The Calibration time and Expected delivery time are the critical Project Input Variable (KPIV) with the highest correlation to Average Pre-calibration time and is the root cause for pharmacies having excessive pre-calibration time. In addition some of the other critical inputs such as TRON and customer contracts were also taken into consideration for the Improve phase. A another regression equation was also tested to see correlation between Value of Tech waste due to excessive pre-calibration time and the Pre-calibration time and there exists a high degree of correlation between them.

Regression Analysis: Average over 6 h versus Activity, ASP,

The regression equation isAverage over 6 hour Precal = - 4.99 - 0.00775 Activity - 0.31 ASP + 20.6 Calibration time - 19.3 Delivery time

Predictor Coef SE Coef T PConstant -4.9892 0.4866 -10.25 0.000Activity -0.007749 0.006703 -1.16 0.257ASP -0.314 1.081 -0.29 0.774Calibration time 20.556 1.088 18.88 0.000Delivery time -19.292 1.504 -12.83 0.000

S = 0.219942 R-Sq = 95.2% R-Sq(adj) = 94.5%

Analysis of Variance

Source DF SS MS F PRegression 4 28.5317 7.1329 147.45 0.000Residual Error 30 1.4512 0.0484Total 34 29.9829

Source DF Seq SSActivity 1 0.1078ASP 1 0.0673Calibration time 1 20.3951Delivery time 1 7.9615

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Regression Analysis: Tech value o versus Average over, Activity, ASP

The regression equation isTech value over 6 hour precal = - 864 + 296 Average over 6 hour Precal + 79.8 Activity - 2450 ASP

Predictor Coef SE Coef T PConstant -864 1772 -0.49 0.629Average over 6 hour Precal 296.3 143.4 2.07 0.048Activity 79.83 25.16 3.17 0.004ASP -2450 5589 -0.44 0.664

S = 780.531 R-Sq = 32.4% R-Sq(adj) = 25.4%

Analysis of Variance

Source DF SS MS F PRegression 3 8465699 2821900 4.63 0.009Residual Error 29 17667618 609228Total 32 26133318

T-Test- A 2 sample T test was also conducted to test the difference between Average Pre-calibration time in June before the project was implemented and the time in October after implementation. The analysis showed that the pre-calibration time dropped by an average 1 hour with the project implementation.

Two-Sample T-Test and CI: Average precal time June, Average Precal time Oct

Two-sample T for Average precal time June vs Average Precal time Oct

N Mean StDev SE MeanAverage precal time June 35 8.151 0.838 0.14Average Precal time Oct 35 7.151 0.838 0.14

Difference = mu (Average precal time June) - mu (Average Precal time Oct)Estimate for difference: 1.00095% CI for difference: (0.600, 1.400)T-Test of difference = 0 (vs not =): T-Value = 4.99 P-Value = 0.000 DF = 68Both use Pooled StDev = 0.8384

ResultsSince the p-value is less than 0.05 we reject the null hypothesis which was taken as there was no difference between the 2 populations and conclude that there is a positive difference between the pre-calibration time measured before the project was implemented to the time measured after which means the time has decreased since project implementation and this is a favorable impact resulting from the project.

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Project X’s

Key input variables coming out of the Analyze were

Calibration time – This is the time at which the requested dose is used for its intended

application. The pharmacist calculates activity that needs to be filled based on customer

requested calibration time.

Delivery time – This is the time when the customer requests delivery of the product at

it’s location.

Customer Contract – Contract is a binding document between Covidien and the

customer which contains information related to pricing, dose limits, calibration times and

freight policy. All negotiated contracts define the long-term commitment between

Covidien and its customers.

TRON – The system used by the pharmacy network to carry out all operations from order processing to delivery of finished product. Since it’s a central processing system for the network, it has a significant impact on operations related to Technetium products.

.

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Improve

Solutions Identified

Critical inputs from the Analyze phase was taken into consideration for improvement in this phase and the “Tc Conservation program” which was launched across the network captures all the improvements which were implemented in the field to achieve the desired objective of reducing pre-calibration time and capturing lost revenue due to excessive pre-calibration time.

Current issues identified with Tc-99m utilization

Significant amount of Tc-99 decaying at the customer site (~6hrs)- 50% of all doses dispensed with greater than 6 hours time- much bulk-tech is ordered with pre-cal for 12:00 am- In past, customers believed “Tc-99 is cheap”, the agent is expensive- customers like security of receiving daily doses early- past delivery issues may drive behavior for this “insurance” time

- lack of standardized calibration policy and no pre-calibration limits in TRON

Tech Conservation - Opportunity

Valuing the saved material at current ASP -> Huge $$$’s• Allows greater patient access to Tc-99m or charge for overage• With generator shortages now and in FY10, we need fast action• Excellent time to begin changing market behavior• Next Steps

- Meeting held with IS requesting TRON changes (80 hrs)- Roll out with Sales management on 8/10/09- Rep and pharmacy web-training (8/28 & 8/31)- Customer letter from marketing distributed on 9/1.- Reps have customer discussions in September- Target Go Live targeted for 9/26/09 (first day of FY10)

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Customer Letter – Summary of Program:

Customer letter will be sent on 9/01/09, which will explain….

• Ongoing concern over global Moly supply• Significant investment required to improve availability• Our goal to increase patient access to Tc-99m based products• Covidien committed to servicing maximum number of patients• New conservation programs beginning on Sept. 26th, 2009(est.)• To promote lower pre-calibration times, Covidien will charge for pre-calibration activity beyond six hours• New charges will be based on bulk Tc-99 pricing• Bulk Tc-99 will be calibrated for actual delivery time, unless customer chooses to pay for additional activity

Example #1 - Limit pre-calibration to 6 hours (expected delivery to cal time)

Example: Customer orders 30 mCi of Sestamibi calibrated for 1300, but wants it delivered with an expected delivery time of 0600. This would trigger a charge up, using the R005A0 code and decay factor to charge them the customer’s bulk Tc-99m charge (say $0.31/mci). We would charge the customer for the hours beyond the 6 hr limit. In this case, it is one hour, so we would charge the customer $0.31 x (30mCi/.891)-30 mCi = $1.14 using a new item code R005PC – TC-99M PRE-CAL OVER TIME LIMIT which will be attached to the dose for reimbursement

Bulk tech will no longer be calibrated past delivery times.

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Customer Impact Analysis - example

This is a calculation of the new cost to each customer if they do not change.Example from the month of June:

Customer Name Tech Value over recommended qty Tech value over 6 hrs pre-cal at ASPALBERT EINSTEIN MED CTR Total $0.00 $1,826.52ATLANTIC MEDICAL IMAGING,GALLOWAY,NJ Total $0.00 $31.39BOOTH RADIOLOGY Total $0.00 $98.36CAPE MAY COURT HOUSE AMI Total $0.00 $23.97CARDIAC DIAGNOSTIC CENTER,LEWES,DE Total $0.00 $0.96CARDIAC DIAGNOSTIC CENTER,MIDDLETOWN,DE Total $0.00 $32.96CARDIAC DIAGNOSTIC CENTER,WILMINGTON,DE Total $0.00 $2.04CARDIOLOGY MEDICAL ASSOC,PHILADELPHIA,PA Total $0.00 $45.27CARDIOVASCULAR SOLUTIONS,PHILADELPHIA,PA Total $0.00 $116.50CHERRY HILL CARDIAC DIAGNOSTIC Total $0.00 $111.73COMM MED CTR Total $134.85 $473.56DOVER CDC,DOVER,DE Total $1.55 $1.15EINSTEIN CTR ONE RADIOLOGY Total $1.55 $84.30KIMBALL MEDICAL CENTER,LAKEWOOD,NJ Total $0.00 $1,690.34LINWOOD AMI Total $0.00 $46.51METHODIST HOSPITAL,PHILADELPHIA,PA Total $0.00 $313.70MOSS REHAB/EINSTEIN AT ELKINS PARK Total $0.00 $371.03NORTH WILMINGTON CDC Total $0.00 $2.04PAMI Total $0.00 $59.12RADIOLOGY ASSOCIATES,WILMINGTON,DE Total $0.00 $11.92SOUTH JERSEY HEART GROUP,SEWELL,NJ Total $0.00 $1.97THOMAS JEFFERSON U HOSP Total $0.00 $185.50UNION HOSP OF CECIL CNTY Total $0.00 $1,343.71WACHSPRESS & SHATKN CARDIO, VINELAND, NJ Total $0.00 $27.97

Grand Total $139.50 $7,013.32

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Sales Rep Actions & Timeline: • Study the customer letter and understand the key points• Review the customer impact analysis with Regional manager• Work with pharmacy manager • Develop preliminary plan using customer knowledge to minimize customer impact• Shift doses to later deliveries, while minimizing impact on delivery costs• Visit with customers• Provide the customer a choice to remain with the status quo or shift schedule• Finalize a plan for each customer with your pharmacy• Understand changes to invoices

• Corporate will add pricing for bulk tech at rep guideline for customers not having this item code currently on their contract

AttendWeb-training

8/28 or 8/31 Wk of 9/7 Wk of 9/14 Wk of 9/21Wk of 8/31

Meet with Reg. MgrMeet with pharmacy team Review customers Develop plan

- Meet with customers Finalize plan with

pharmacy

Sat. 9/26

-Target Go Live- Meet with customers

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Pharmacy Managers Actions:

• Study the customer letter and understand the key points• Review the customer impact analysis with your sales team• Develop a preliminary plan to minimize customer impact• Ensure you are capturing accurate expected delivery times in TRON for all customer orders.• Consider shifts in delivery schedules without increasing costs• Utilize existing scheduled runs and routes• If freight costs exceed Tc-99m savings, exceptions approved by VP Ops, VP of Sales, and Marketing through email.• Make certain to capture freight revenue for these exception accounts• Understand changes to TRON and invoices• Finalize a plan for each customer• On Go Live date, begin calibrating all bulk tech at delivery time

• Note that corporate will add pricing for bulk tech at rep guideline for customers not having this item code currently on their contract

Sales Rep talk track: • Reference the customer letter• Explain that Tc-99m shortage will continue far into 2010• Our focus is on increasing patient access to Tc-99m products• Asked your customers to use Tc-99m more efficiently• Explain how doses can be delivered on later runsIf they purchase bulk tech, explain new pre-calibration policyGive them their options for:

1 Unit doses with excess (> 6 hours) of calibrationa.) Move doses to later scheduled runsb.) Pay for extra activity

2 Bulk Tc-99m ordersa.) Move orders to later scheduled runsb.) Reduce sizes of bulk Tc-99m ordersc.) Pay for extra activityd.) Eliminate bulk Tc-99m orders and utilize STAT unit dose orders where needed.

• It’s the customers choice • Use your Tools -> Moly calendar, delivery schedules, customer impact

analysis, Moly shortage update letter

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TRON Invoice change?

Invoices will show the added Tc-99 charges similar to I-131 caps.

Invoices will reflect any necessary surcharges on the line following the applicable dose, assigned to the same prescription number for reporting ease.

The following product codes and descriptions will appear to indicate the surcharge type(s):

R005PC - TC-99M SODIUM PERTECHNETATE ACTIVITY OVER PRE-CALIBRATION TIME LIMIT (PER MCI)

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ControlThe updated process flow shows the changes made to the TRON pharmacy system to generate invoices capturing the surcharge for products exceeding the 6 hour pre-calibration limit.

Updated Process Map

Pharmacy receives Customer Standing/Demand Order for Tech dose Calibration time,

Delivery time

Dispense Dose with activity related to calibration time

Is dose matching with BOL

Tech dose is ship confirmed

Dose delivery to customer at requested delivery and calibration time

Pharmacy bills customer and collects sales revenue for dose sale

NO

YES

Pharmacist enters order in

TRON and generates

prescription

Check Order

Pharmacy Invoicing

$$

Updated Process Flow Map for Tc 99 Precalibration

Pharmacy adds new customer, negotiates existing customer contracts, communicates

any change in policy or contract

Is unit dose over 6 hour pre-calibration?Bulk dose over delivery

time?Excess

surcharge billed to

customer invoice

YES

NO

Customer changes delivery schedule, adjusts calibration times to adhere to Tech

Conservation program

Exception raised if freight revenue exceeds Tech

savings

Exception sent to Pricing for

adjustment and surcharge

adjusted to $0

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Updated FMEA

The FMEA was also updated based on the new process flow effect on critical inputs and RPN’s were recalculated. With new controls in place the numbers went down significantly.

Process or Product Name:Improve Tech Precalibration

Prepared by: Ramesh Rajan

Page __1__ of __1__

Responsible: Ramesh Rajan FMEA Date (Orig) _September 29th, 2009_______ (Rev) ______1_______

Process Step InputPotential Failure

ModePotential Failure

Effects

SEV

Potential CausesOCC

Current ControlsDET

RPN

Actions Recommended Resp. Actions TakenSEV

OCC

DET

RPN

Step of the process under investigation

Input under investigation? In what ways does the Key Input go wrong?

What is the impact on the Key Output Variables (Customer Requirements) or internal requirements?

How

Seve

re is

th

e ef

fect

to th

e cu

sotm

er?

What causes the Key Input to go wrong?

How

ofte

n do

es

caus

e or

FM

oc

cur?

What are the existing controls and procedures (inspection and test) that prevent either the cause or the Failure Mode? Should include an SOP number.

How

well c

an y

ou

dete

ct c

ause

or FM

? What are the actions for reducing the occurrance of the Cause, or improving detection? Should have actions only

on high RPN's or easy fixes.

Whose Responsible for the recommended

action?

What are the completed actions taken with the recalculated RPN? Be

sure to include completion month/year

Pharmacy receives customer order

TRON Excessive

precalibration Product decay , Lost

revenue 8 Lack of limits on calibration time 7 None 8 448 Implement limits on pre-calibration time

Pharmacy management

TRON programming completed on 9/25 and new

invoicing implemented3 6 4 72

Dose dispensed with activity related to calibration time

Expected Delivery time Inaccurate delivery

time Product Decay 7 Customer Behaviour 8

Customer Delivery schedule

7 392Sales rep/Pharmacy mgmt work with

customer to implement route changes, delivery times

Pharmacy /CustomerSales rep met with customers in Sept

5 5 5 125

Pharmacy negotiates existing contracts, communicates changes

Customer Contract, Calibration policy

Miscommunicaiton or lack of

standardized policy

Lost revenue due to product decay, excess

inventory 8

Lack of attention to true need, overemphasis on safety insurance

8Customer Communication

by Sales reps6 384

Sales rep/Pharmacy mgmt work with customer to implement standard

calibration time into policyPharmacy /Customer

Sales rep met with customers in Sept,

renegotiated customer contracts

5 4 4 80


Calibration time Excessive

precalibration Product Decay 9

Historical customer behaviour, resistant to change

8 Customer Communication 5 360

Customer Contract, Calibration policy

No adherence to policy

Lost revenue due to product decay, excess

inventory 8

Customer demand, variation in Tech needs

7Customer Communication

by Sales reps6 336


Calibration time Excessive

precalibration Unfavourable product

margin9

Lack of standardized policy/contract terms

7 Contract, Calibration policy 5 315

Expected Delivery time Inaccurate delivery

time Product Decay 7

Lack of foresight, Product Insurance

8Delivery time loaded in

TRON 4 224


TRON Incorrect activity

dispensed Product decay, loss of

revenue6

No activity limits in TRON, wrong order entry

6 TRON checks 2 72

0

Process/Product Failure Modes and Effects Analysis

(FMEA)

Validation/Verification

A financial tracking spreadsheet has been developed by Finance which captures actual savings from the network since implementation of the Tech Conservation program. The Tc/Mo ratio will also be monitored monthly to see how pharmacies are performing related to their Technetium utilization. A monthly tracking sheet will be also circulated by senior management showing how many Technetium doses are freed up by the network to calculate additional revenue.

28

document.doc

Visual Tracking

Savings Tracking Report –Oct 09

Ship Date Product Number (SKU) Product Description Sales Qty Eaches Gross Sales Gross Sales total

09/26/2009 R005PC TC-99M PRE-CAL OVER TIME LIMIT 21,636.31 8,107.36 661.59 8,768.95 09/27/2009 R005PC TC-99M PRE-CAL OVER TIME LIMIT 41,104.46 14,985.83 357.87 15,343.70 09/28/2009 R005PC TC-99M PRE-CAL OVER TIME LIMIT 16,675.42 7,209.64 4,514.02 11,723.66 09/29/2009 R005PC TC-99M PRE-CAL OVER TIME LIMIT 16,934.13 8,175.33 4,672.88 12,848.21 09/30/2009 R005PC TC-99M PRE-CAL OVER TIME LIMIT 15,166.67 7,368.64 4,165.06 11,533.70 10/01/2009 R005PC TC-99M PRE-CAL OVER TIME LIMIT 14,077.41 6,211.98 3,816.09 10,028.07 10/02/2009 R005PC TC-99M PRE-CAL OVER TIME LIMIT 12,988.70 5,976.38 3,555.21 9,531.59 10/03/2009 R005PC TC-99M PRE-CAL OVER TIME LIMIT 20,313.09 8,105.18 737.07 8,842.25 10/04/2009 R005PC TC-99M PRE-CAL OVER TIME LIMIT 48,704.10 18,165.00 384.10 18,549.10 10/05/2009 R005PC TC-99M PRE-CAL OVER TIME LIMIT 11,654.51 5,382.31 4,343.16 9,725.47 10/06/2009 R005PC TC-99M PRE-CAL OVER TIME LIMIT 13,555.44 6,793.08 4,190.23 10,983.31 10/07/2009 R005PC TC-99M PRE-CAL OVER TIME LIMIT 12,771.31 6,148.21 4,052.78 10,200.99 10/08/2009 R005PC TC-99M PRE-CAL OVER TIME LIMIT 12,347.78 6,080.91 3,823.14 9,904.05 10/09/2009 R005PC TC-99M PRE-CAL OVER TIME LIMIT 12,003.99 5,381.76 3,204.34 8,586.10 10/10/2009 R005PC TC-99M PRE-CAL OVER TIME LIMIT 19,460.06 7,603.59 546.16 8,149.75 10/11/2009 R005PC TC-99M PRE-CAL OVER TIME LIMIT 47,993.70 17,755.36 388.83 18,144.19 10/12/2009 R005PC TC-99M PRE-CAL OVER TIME LIMIT 11,310.67 5,084.57 4,168.62 9,253.19 10/13/2009 R005PC TC-99M PRE-CAL OVER TIME LIMIT 12,153.49 5,240.49 4,732.70 9,973.19 10/14/2009 R005PC TC-99M PRE-CAL OVER TIME LIMIT 12,175.55 5,715.59 4,284.32 9,999.91 10/15/2009 R005PC TC-99M PRE-CAL OVER TIME LIMIT 12,044.42 5,019.04 3,940.53 8,959.57 10/16/2009 R005PC TC-99M PRE-CAL OVER TIME LIMIT 13,862.71 5,922.37 3,449.18 9,371.55 10/17/2009 R005PC TC-99M PRE-CAL OVER TIME LIMIT 18,156.91 6,715.75 702.12 7,417.87 10/18/2009 R005PC TC-99M PRE-CAL OVER TIME LIMIT 49,250.43 18,440.43 360.10 18,800.53 10/19/2009 R005PC TC-99M PRE-CAL OVER TIME LIMIT 14,570.63 6,597.59 4,316.83 10,914.42 10/20/2009 R005PC TC-99M PRE-CAL OVER TIME LIMIT 11,439.76 5,141.51 4,581.45 9,722.96 10/21/2009 R005PC TC-99M PRE-CAL OVER TIME LIMIT 10,491.10 4,259.54 4,288.95 8,548.49 10/22/2009 R005PC TC-99M PRE-CAL OVER TIME LIMIT 8,699.08 3,666.32 2,922.82 6,589.14 10/23/2009 R005PC TC-99M PRE-CAL OVER TIME LIMIT 5,692.03 2,255.13 2,387.71 4,642.84

Total $297,057

29

document.doc

Tc/Mo Ratio Tracking

Oct-09 Sept Report Oct ReportSite Region TC/mo RATIO TC/mo RATIO change

65 Dayton Allegheny 1.45 1.45 0.0074 St Paul West 1.80 1.40 -0.4076 Orlando Central 1.56 1.27 -0.2992 Cleveland Allegheny 1.40 1.26 -0.1477 Detroit Allegheny 1.42 1.26 -0.1673 Kansas City Central 1.33 1.18 -0.1585 Chicago Central 1.53 1.09 -0.4479 Wilkes-Barre Northeast 1.26 1.09 -0.1762 Crestwood Central 1.31 1.09 -0.2287 Atlanta Central 1.37 1.08 -0.2961 Toledo Allegheny 1.16 1.01 -0.1598 Philadelphia Northeast 1.53 1.01 -0.5275 Ft Lauderdale Central 1.20 0.98 -0.2299 Houston West 1.22 0.98 -0.2469 Denver West 1.47 0.97 -0.5097 Altoona Northeast 1.27 0.95 -0.3257 Saginaw Allegheny 1.25 0.95 -0.3093 Dallas West 1.20 0.92 -0.2878 Boston Northeast 1.03 0.91 -0.1282 Los Angeles West 1.33 0.91 -0.4290 St Louis Central 1.41 0.90 -0.5184 Pine Brook Northeast 1.37 0.89 -0.4886 St Pete Central 1.43 0.88 -0.5588 Hicksville Northeast 1.19 0.87 -0.3267 Loma Linda West 1.13 0.82 -0.3195 Harrisburg Northeast 1.29 0.81 -0.4896 Bethlehem Northeast 1.33 0.78 -0.5581 San Francisco West 1.09 0.78 -0.3194 Pittsburgh Allegheny 1.41 0.76 -0.6572 Miami Central 0.56 0.70 0.1463 Columbus Allegheny 1.27 0.68 -0.5983 Milford Northeast 0.89 0.67 -0.2266 Portland West 0.74 0.61 -0.1360 Cincinnati Allegheny 0.94 0.56 -0.3880 Beltsville Allegheny 1.46 0.50 -0.9658 Memphis Central 0.62 0.36 -0.26

Avg network Tc/Mo Ratio 1.26 0.93 -0.33

30

document.doc

Daily dose Availability by pharmacy

Site Daily DosesDaily Doses

Pittsburgh 118 118Columbus 12 12Dayton/Cincinnati 50 50Beltsville 60 60Cleveland 20 20Toledo 25 25Detroit 20 20Saginaw 14 14

Total Allegheny 319


Boston: 10 10Milford: 10 10Hicksville: 15 15Pine Brook: 100 100Philadelphia: 60 (Was 80) 60Bethlehem: 6 6Wilkes-Barre: 0 0Harrisburg: 50 (Was 25) 50Altoona: 0 0

Total Northeast 251


Orlando 16 16St Petersburg 30 30Miami 40 40Ft Lauderdale 100 (Was 200 but made generator reductions) 100Atlanta 20 20Memphis 4 (only based on replacing conserved Tc) 4Kansas City 24 24St Louis 20 20Elk Grove 40 40Crestwood 50 50

Total Central 344


Denver 26 26St. Paul 52 52Portland 50 50Loma Linda 6 6San Francisco 13 13LA 16 16Houston 60 60Dallas 10 10

Total West 233

Grand Total 1147

31

document.doc

Control Plan Summary

1. Pharmacy management will track the monthly Tc/Mo utilization summary to

see how they are performing with their Tech utilization. They will accordingly

adjust their generator mix and production schedule to achieve maximum

efficiency.

2. Target sales goal will be set by pharmacy to maximize use of freed up “Tc

doses” resulting from implementation of the “Tc Conservation program”.

3. Pharmacy management would continue communications with customer and

work with them to implement changes to their delivery, calibration schedule

to minimize impact from the excess pre-calibration surcharge.

Process Capability

An updated process capability analysis was performed after the project implementation. The Cpk though a negative 0.46 shows improvement from the pre-program capability and points to the success of the ‘Tc Conservation program”.

343128252219161310741

10.0

7.5

5.0Indiv

idual V

alu

e

_X=7.151

UCL=9.669

LCL=4.633

343128252219161310741

3.0

1.5

0.0

Movin

g R

ange

__MR=0.947

UCL=3.093

LCL=0

3530252015

8

7

6

Observation

Valu

es

9.07.56.04.53.01.50.0

LSL USL

LSL 0USL 6

Specifications

10864

Within

Overall

Specs

StDev 0.839367Cp 1.19Cpk -0.46

WithinStDev 0.838408Pp 1.19Ppk -0.46Cpm *

Overall

Process Capability Sixpack of Average Precal time OctI Chart

Moving Range Chart

Last 25 Observations

Capability Histogram

Normal Prob PlotAD: 0.180, P: 0.910

Capability Plot

32

document.doc

Project Benefits

Value of Tc-99 pre-calibrated over 6 hours @ ASP = $0.5 million

Value of Bulk Tc-99 delivery time calibration @ ASP = $2.5 million

Usage of saved material at current ASP ->(approx value - $7Million)

Allows greater patient access to Tc-99m even in situations of Tc-99m

shortage

The implementation of the “Tc Conservation program will lead to a

more efficient production and distribution structure for the pharmacy

network.

33

Appendix

Appendix 1- Financial tracking

Tc-99 Conservation Plan Daily Sales

-

2,000.00

4,000.00

6,000.00

8,000.00

10,000.00

12,000.00

14,000.00

16,000.00

18,000.00

20,000.00

9/26

/200

9

9/28

/200

9

9/30

/200

9

10/2

/200

9

10/4

/200

9

10/6

/200

9

10/8

/200

9

10/1

0/20

09

10/1

2/20

09

10/1

4/20

09

10/1

6/20

09

10/1

8/20

09

10/2

0/20

09

10/2

2/20

09

Days

Sal

es $

's Over Pre-cal timeOver Dose RangeTotal Revenue

34

Appendix-2, FAQ for Technetium Conservation Project

Technetium 99m (Tc 99m) Conservation Plan FAQ’sFOR INTERNAL USE ONLY

Potential Customer Questions

1. How will my reimbursement be impacted by Covidien’s new program? The new invoice will reflect a total cost per dose for the RP product- see below. Therefore, for those customers that are paid based on "reported acquisition cost", which include physician offices and freestanding facilities under the Medicare program--there should not be a problem, but we cannot guarantee reimbursement. For hospital customers, the cost of a diagnostic RP dose is bundled or packaged into the total payment for the procedure, so there is no line item reimbursement for the RP dose-- at least under the Medicare program. Therefore, this surcharge will most likely become an incremental cost.

2. What criteria did Covidien use to establish the contractual dosing range activity limits? Covidien used each product’s package insert and current industry practice as guidelines to establish dose activity ranges.

3. Does the bulk calibration at delivery only apply to one product code? Will Tc 99m unit doses (GI Bleed, MUGA, etc.) be treated as a unit dose, good up to 6 hours post delivery? No, bulk Tc 99m will include product code R005A0 and other bulk tech codes (MDP bulk, Choletec bulk, HDP bulk, etc). All other Tc 99 dose codes will be reviewed to determine whether the dose contains activity over our policy. The unit dose Tc 99m code R011A0 has a range of 1-25mCi’s and activity overages will be charged at the bulk Tc 99m ASP per mCi.

4. Can our hospital still purchase bulk Tc 99 (R005A0) pre-calibrated for a time later than expected delivery? Yes, you may still purchase bulk Tc 99 with calibration times post delivery. However, you will be charged for the additional Tc 99m required using your current ASP for that product. We will calculate the additional activity using exact time decay factors.

5. Can I use doses which are under Covidien’s contractual activity ranges to offset doses we purchased over the contractual dose ranges? No, you will not be able to offset incremental dose costs due to extra Tc 99 activity over range or hours. Doses within the range are billed at your contractual rates. This program only impacts doses over the activity ranges stated in your contract.

6. Example #1 Limiting dose activity to contractual range: Customer orders 45mCi of sestamibi calibrated for 1300. The package insert recommends 30mCi. This would trigger an additional charge, using the R005A0 bulk Tc 99m code, for the difference between the recommended activity and the ordered activity at their contracted bulk price (i.e., $0.31/mCi). In this case, it is 15mCi, so we would charge the customer $0.31 x 15mCi = $4.65, using the new item code R005TL – TC-99M ACT OVER DOSE LIMIT MC. This line item charge will be attached to the dose on the invoice to aid billing clarity for potential reimbursement.

7. Example #2 Limiting pre-calibration to 6 hours: Customer orders 30 mCi of sestamibi calibrated for 1300, but wants it delivered at 0600. This would trigger an additional charge, using the R005A0 bulk Tc 99m code and decay factor for the additional activity required for the earlier delivery, charging them their bulk price for the difference (i.e., $0.31/mci). We would charge the customer for the hours beyond the 6 hour policy limit. In this case, one hour of added activity is needed, so we would calculate the customer surcharge at $0.31 x (30mCi/.891) -30 mCi = $1.14, using the new item code R005PC – TC-99M PRE-CAL OVER TIME LIMIT. This line item charge will be attached to the dose on the invoice to aid billing clarity billing for potential reimbursement

35

8. Example #3 Limit dose activity to range and pre-calibration: Customer orders 45 mCi of sestamibi calibrated for 1300, but wants it delivered with an expected delivery time of 0500. This would trigger an additional charge for both extra time and activity. Using the R005A0 code and decay factor we calculate the charge to them with the customer’s bulk Tc 99m ASP (i.e., $0.31/mCi). We would charge the customer for the additional 2 hours beyond the 6 hour limit and for the additional 15 mCi of activity.

For the added hours, we would charge the customer $0.31 x (45mCi/.7943) -45 mCi = $3.61 using new item code R005PC – TC-99M PRE-CAL OVER TIME LIMIT, which will be attached to the dose on the invoice to aid billing clarity for potential reimbursement.

For the additional activity, we would charge the customer $0.31 x 15mCi = $4.65, using new item code R005TL – TC-99M ACT OVER DOSE LIMIT MC that will be attached to the dose on the invoice to aid billing clarity for potential reimbursement.

The total dose would cost $47.00 plus $3.61 plus $4.65 for a total ASP to the customer of $55.26.

9. How will the new charges appear on an invoice? The new invoice will reflect a total cost per dose Rx number for the nuclear medicine product with each line item charge also shown (see below).

Potential Pharmacy Questions

10. Will TRON alert the pharmacy that an extra charge will be applied? Right now, TRON will not alert the user to the extra charges. TRON will use the delivery time field, pre-cal time, and the dose size to calculate the extra charge and it will be automatically added to the invoice.

11. Does the program impact Premier accounts? Premier customers serviced by Covidien pharmacies will be included in this program. At this time, Premier customers serviced by a virtual network partner will not be included. However, we are working with our virtual network partners to capture the data needed to add them to the program at a future date.

12. How important are the commit times in TRON? Commit time or expected delivery time is a key field used, in addition to the pre-cal time, to calculate the additional charges. Please review this important TRON field and enter the time that the customer requested delivery, not the actual time of delivery. Make sure all standing and demand orders contain the correct requested delivery time.

36

13. What happens if my pharmacy errs by sending a dose on an earlier run, which will add extra charges to the dose? Sending doses on earlier runs will not increase the incremental charges, as long as the delivery time you enter is the time the customer requested it, not when you deliver it. For example, if you deliver something 2 hours earlier for Covidien’s convenience or for freight efficiency—i.e.,1000--that's fine, but make sure the delivery time entered in TRON reflects the customer’s specified time—i.e.,1200.

14. What happens if our pharmacy has a late delivery? I envision some of my customers wanting credit for bulk every time a delivery is late, assuming it is pharmacy or courier related and not weather or traffic. Will we provide a credit? If the late delivery is unavoidable, a credit may be warranted. If you suspect a problem, then you may push back the expected delivery time in TRON for that day. This would correct for the lost time and avoid the customer from being charged for the time.

15. I’m concerned about the extra burden on the pharmacy, especially weekends and On Call hours. We understand on weekends the profitability of the program may suffer, but when performing your customer analysis, look at that customer's activity over a week or month. Over time, in most cases the savings will outweigh the incremental costs. Also, please be creative to serve your customers by minimizing the impacts during the evening and weekend hours. It is likely our pharmacy practices will change over time to avoid additional pharmacy burdens.

16. What if my analysis shows that the cost of delivering multiple times to a particular customer outweighs the Tc 99 savings? If your freight costs are higher than the savings, an exception request template should be completed and emailed to your manager for approval. You should also copy Ramesh Rajan at corporate. Once the exception is approved by the Vice Presidents of Operations and Sales, marketing will send the approved request to the Pricing department. They will set the ASP for the new codes to -0-, which will negate any new charges for that customer.

17. How will TRON calculate the pre-calibration overages? Our TRON system uses exact time decay factors, along with the current bulk ASP/mCi to determine the charge for the additional technetium included in doses exceeding pre-calibration limits.

18. I noticed one of my customers does not have an expected delivery time entered on all their orders; what should I do? Please make sure your pharmacy has loaded correct delivery times in both standing and demand orders for the time the customer requested delivery or your customer’s invoice may not be accurate.19. Will there be any other product codes with the pre-calibration set at zero hours or time of delivery? Yes, bulk tech will include R00A50 and these bulk codes:

37

Documents

Improve Tech Pre Calibration Project Book