Implant Standardization in Pediatric Spinal Deformity Surgery Process, Benefits, Side Effects, and Lessons Learned Wally Krengel, MD Chief of Spine Program, Department of Orthopedics and Sports Medicine Seattle Children’s and University of Washington
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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
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
X T4
X T5 X ↓
X T6 ↑ T7 ↑
↑ 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?
-0.5
0
0.5
1
1.5
2
0 2 4 6 8 10 12 14 16
Cor
rect
ion
(Raw
)
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
• 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
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