Implant Standardization in Pediatric Spinal Deformity Surgery

Process, Benefits, Side Effects, and Lessons Learned

Wally Krengel, MDChief of Spine Program, Department of Orthopedics and Sports MedicineSeattle Children’s and University of Washington 

Overview

• Toyota Method / CPI at Seattle Children’s• Standardization• Spine Implant Standardization • Results Of Implant Standardization• Lessons Learned

All Clinical Leaders go through CPI TrainingCPI  = Continuous Process Improvement

Analysis of Results and Managing Change Difficult without 

Standardization 

Performance

Target

Standardization Success StoriesTreatment of ALL  

National Quality Assurance Programs (NSQIP) (SSI tracking) Focused Attention on Safety Improvements

Cardiac Surgery Infection Rates: Adler et al, J Ped Inf Dis

Standardization in Spine Program SCHStandard QA Process not Industry Funded Registry

SSI TrackingAIS Surgical ChecklistsImplantsAnesthesiaSCMD/C SummaryHRQOLOutcomes

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Perioperative Antibiotic Timing- Spinal Fusions

pre-op 0-60 min prior to incision %_redosed_per_guideline

Pre‐Scheduling Safety Checklist for AIS

Post‐operative Checklist

Clinical Standard Work Dashboards

Discharges Charges Length of Stay

Readmission

Strategic Planning 

Spine “Value Stream” Session 

Familiarity, Processing, Set‐upPurchasing, Availability

Variation In AIS Implants4 Surgeons, 3 Vendors, Many Patients

• Hooks, Screws, Wires, Rods, Crosslinks

Effect of Implant Strategy on Outcomes

• National Meetings, Publications focus on increasingly complex and costly implants– Leaders in field advocating these– Outcomes – X‐ray correction (5 degrees?), SRS 24 HRQOL

– Standard Surgical Quality / Safety?

=?

Implant Standardization Planning

• Measure Current State > PDCA• Strategy – Standardize Construct, Vendor, Price? ( optimize process for Purchasing, Processing, Prep,       Training of Techs, …)

• Barriers: Surgeon Willingness– Training, Familiarity, Vendor Relationships, Safety– Would Need Strong Case / Data

• Goal ‐ Decrease variation– Familiarity of Surgical Techs, Set‐up– Inventory, Stocking, Sterile Processing– Avoid non‐availability, Have multiple sets in house– Avoid any deterioration in surgical outcomes

How Much Variation?

Standardize Constructs?Surgical Anchor Assessment

Case 1.1Left Right

Surgeon A Surgeon B Surgeon C Surgeon D A B C D

T1

↓ ↓ T2 ↑ ↑ T3 8

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↑ X X T8

X X T9 X X ↑ X X X T10 XX X T11 8X X T12 X

X L1 XL2

L3

L4

L5

Surgeon Screws Hooks TotalA 11 2 13B 7 5 12

C 19 0 19D 11 2 13

4 of 4 53 of 4 92 of 4 3

24 possible

More Anchors Improves Correction?

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Anchors/ Level in Main Curve

Main Curve- Correction Versus Anchors/Level - AIS FY08-09

More Pedicle Screws!!!Better Outcomes?

Single Vendor RFP

• Focus on quality, safety and achieving goals• Objective – all “had a chance”• Transparent grading system• Inclusive – Purchasing, Processing, Nurses, Techs, Surgeons all involved

• Avoidance of outside influences (Other deals linked to vendor)

“Vendor Fair”

• Agreement pre‐RFP included– Sterile Processing Pans– Custom implant trays with specific variety of implants

– Modifications to set– 4 trays only (not 17), Weight limited to 25 pounds– Update sets with improvements as available– Service Agreement and assessment– Prep period  Began 1/1/2011

Grading

• Familiarity• Service• Quality• Safety• Sterilizer Pans• Cost

Pre and Post RFP Metrics

• Prep time, Nonop time, Surgical Time, Complications, Return to OR, Infection, turnover time, SRS‐30 (HRQOL) scores pre and post, EBL, Transfusion, Satisfaction of surgeons, staff, processing…

• Some easy to track, Many Not.

Results

• SSI • Complications• Satisfaction of Staff• Sterile Processing and Set‐up• Availability of Implants• Service

Results: Demographics and Blood Loss

Before RFP After RFPN 25 24

Age (AVG) 14.5 +/‐ 2.1  14.4 +/‐ 2.0Gender(F:M) 15:10 24:0

Wt (KG) 54.58 +/‐ 12.46 54.43 +/‐ 11.04

Levels Fused 10.04 +/‐ 2.65 10.36 +/‐ 2.31

LOS 4.0 +/‐1.1 5.0 +/‐1.6EBL 430 +/‐ 324 402 +/‐ 268

EBL/Level 43.35 +/‐ 29.45 38.7 +/‐ 23.19

EBL/Level/KG 0.87 +/‐ 0.67 0.75 +/‐ 0.52

Results: Process TimesTimes     Before RFP After RFP

N 25 24Total OR time 4:57 +/‐ 0:58 5:40 +/‐ 0:46Operative Time(Incision ‐ close) 3:21 +/‐ 0:55 3:54 +/‐ 0:39

Op time / level fused 0:20 0:23

In room ‐ Incision Time 1:08 1:18

Close ‐ Out of Room 0:27+/‐ 0:16 0:27+/‐0:10Total Non‐op Time 1:36 +/‐ 0:25 1:45 +/‐ 0:23Total Non‐op Time / 

Levels Fused 0:10 0:10

Pre‐RFP vs. Post‐RFP Implant Costs

Before RFP After RFP

Cost Description Average STDEV Average STDEV

Implant Invoice total 19,226.33 6065.00 12,746.74 3,453.22

Implant Invoice total / level 1,996.27 918.23 1,369.88 828.90

Hospital Charges total / Level 15,325.41 6,042.83 15,623.96 5,898.28

Summary

• Standardization Decreased Cost 33%  /  $650,000 / year

• Confounders Abundant• No Significant Deterioration in Other Outcomes

• Many Positive Byproducts 

Lessons Learned

• Lots of Variables that can’t be controlled• Cost Effectiveness  ‐ Resource Intense

– Standardize Data Input > Easier Data Retrieval• Time Consuming!!!

– PA’s, NP’s, Younger MD’s more willing

• Standardizing One Thing Leads to Many Others– Pre‐Scheduling Checklist, Sterilizer Pans, CSW Dashboard, D/C Summary, HRQOL Forms Online, Transfusion Record, Implant Evaluation Process

Thank You