Proposed Expansion of the Patient Safety Indicator Set Patrick S. Romano, MD MPH UC Davis/USA
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1 Proposed Expansion of the Patient Safety Indicator Set Patrick S. Romano, MD MPH UC Davis/USA OECD Health Care Quality Indicators Patient Safety Subgroup 9 May 2012
2 AHRQ PSIs endorsed by OECD (after review of data limitations) Foreign body left in during procedure (PSI 5) Catheter associated bloodstream infection (PSI 7) Dropped due to problems with international comparability given lack of specificity of ICD-10 code Postoperative pulmonary embolism or deep vein thrombosis (PSI 12) Postoperative sepsis (PSI 13) Accidental puncture and laceration (PSI 15) Obstetric trauma - vaginal delivery w instrument (PSI 18) Obstetric trauma - vaginal delivery w/out instrument (PSI 19) 2
3 Key learnings from Many OECD countries can report PSI rates using either ICD-9- CM or ICD-10 coded data Age/sex standardization can be performed but has little impact on cross-country comparisons Same-day or short-stay cases need to be excluded Some exclusions (e.g., non-elective admissions) have erratic effects and must be modified or dropped for cross-country comparisons Mean number of coded secondary diagnoses varies greatly across countries (even with similar number of fields) and may be a major source of bias in cross-country comparison; adjustment techniques may reduce this bias
4 2011 recommendations to OECD HCQI program Consider procedure-linked or procedure-stratified indicators for future work More consistent coding across hospitals and areas Reduce bias due to variation in risk across countries Different countries use different procedure classification systems, requiring more mapping effort to ensure comparability Postoperative wound dehiscence Postoperative hemorrhage or hematoma Postoperative respiratory failure Iatrogenic pneumothorax Postoperative metabolic derangement (renal failure)
5 Validation findings in USA Medical record review as gold standard Name VA AHRQ UHC PPV (%) Sample PPV (%) (95% Sample PPV (%) Sample (95% CI) (n)* CI) (n) (95% CI) (n) Decubitus Ulcer 30 (22-40) (30-35) 2035 Foreign Body Left in During Procedure 46 (36-55) Iatrogenic Pneumothorax 73 (64-81) (73-82) Central Venous Catheter-related 38 (29-47) (51-71) Bloodstream Infections Postoperative Hip Fracture 28 (15-43) Postoperative Hemorrhage or 75 (66-83) Hematoma 78 (62-95) Postoperative Physiologic and Metabolic Derangements 63 (54-72) 119 * 85 (78-90) Postoperative Respiratory Failure 67 (57-76) (77-89) 609 Postoperative PE or DVT 43 (34-53) (42-52) (37-51) 452 Postoperative Sepsis 53 (42-64) (28-54) Postoperative Wound Dehiscence 87 (79-92) Accidental Puncture or Laceration 85 (77-91) (86-94) Note that procedure-linked or stratified indicators (in bold) tend to have high PPV
6 Validation findings in USA: POA reporting Percentage reported as NOT POA (%) PSI/PDI NACHRI Mich CA NY Mayo PSI 1: Complications of Anesthesia PSI 3: Decubitus Ulcer PSI 5: Foreign Body Left During Proc PSI 6: Iatrogenic Pneumothorax PSI 7: Infection Due To Medical Care PSI 8: Postop Hip Fracture PSI 9: Postop Hemorrhage or Hematoma PSI 10: Postop Physiologic or Metabolic PSI 11: Postop Respiratory Failure PSI 12: Postop DVT or PE PSI 13: Postoperative Sepsis PSI 14: Postop Wound Dehiscence PSI 15: Accidental Puncture/Laceration PSI 16: Transfusion Reaction 71 N/A Procedure-linked and stratified PSIs (highlighted) are unlikely to be present on admission.
7 Obstetric trauma (PSI 18/19): validation findings California Obstetric Validation Study (Romano et al., 2005): Stratified random cluster sample of 1,662 records from 52 hospitals (51% vaginal) Sensitivity=90% (95% CI, 82-96%) and PPV=90-95% Adjusted sensitivity=93% (95% CI, 82-97%) and PPV=73% Clinical research data set (Brubaker et al. 2007): 393 indicator-positive and 383 indicator-negative vaginal deliveries Sensitivity=77% (95% CI, 72-81%) Specificity=99.7% (95% CI, %) PPV could not be estimated due to the sampling design, but should be approximately 93% given a typical prevalence of 5% English NHS study (Bottle and Aylin, 2008): 955 cases from 18 English NHS trusts sampled PPV=85% (none present at admission, 15% miscoded)
8 PSI 12: Postoperative DVT/PE after TKA Follow-up study of PPV in 15 academic centers Chart Abstraction 125 cases True Positive postop lower ext DVT or PE 126 VTE flagged by PSI 12 (+4 Readmission) 1 case clinical False Positive (superficial) saphenous Vein Positive Predictive Value = TP / (TP + FP) = Overall updated PPV from 7 volunteer hospitals = 126/156 = 81% Most FPs due to acute preoperative events (19) or miscoded location of DVT (10)
9 PSI 12: Postoperative DVT/PE after TKA Follow-up study of NPV in 15 academic centers Chart Abstraction 3 cases False Negative 5 cases had VTE per UHC abstract 463 Not flagged as VTE by PSI 12 2 cases superficial or upper extremity thromboses 458 cases had no VTE (TN) Negative Predictive Value = TN / (FN + TN) = 458 / (458+3) = Previous sensitivity estimate from 33 teaching hospitals: 96% (95% CI: %) 100% if limited to acute DVT or PE
10 PSI 6: Iatrogenic pneumothorax Overall PPV 73% (VA) or 78% (nonfederal) FPs due to inadequate documentation, such as rule out pneumothorax without alternative diagnosis established after study (CXR or CT) Most TPs related to failure to use bedside ultrasound guidance during placement of central venous catheters, especially in the OR, ICU, and ED (proven to reduce iatrogenic injury during IJ/SC vein placement)
11 2003 Q2 (N=2969) 2003 Q4 (N=4439) 2004 Q2 (N=4533) 2004 Q4 (N=4474) 2005 Q2 (N=4615) 2005 Q4 (N=5010) 2006 Q2 (N=5139) 2006 Q4 (N=5063) 2007 Q2 (N=5195) 2007 Q4* (N=5164) Case study: Iatrogenic pneumothorax One hospital s experience recognizing and responding 3.5 AHRQ Patient Safety Indicators Iatrogenic Pneumothorax Rate per 1000 Observed Target UHC Median
12 Iatrogenic Pneumothorax Data Note that this hospital was able to reduce its IP rate well below the median for teaching hospitals (UHC) and to achieve benchmark/target performance.
13 PSI 9: Postoperative Hemorrhage/Hematoma Screens for hemorrhage or hematoma requiring operative treatment following a surgical procedure 31 hospitals from 11 states participated N=181 flagged and N=281 unflagged records PPV = 78% (95% CI 62-95%) or 93% from coding alone NPV = 99.7% ( %) Sensitivity = 49% (26-72%) Specificity = 99.9% ( %) Sensitivity was improved to 87% by adding certain procedure codes to indicator denominator Specification of diagnosis codes as postoperative may improve PPV in some versions of ICD-10
14 PSI 10: Postoperative Physiologic or Metabolic Derangement Screens for acute kidney injury requiring dialysis and diabetes-related coma, ketoacidosis, or hyperosmolarity after elective surgical procedure 35 hospitals from 11 States participated N=94 flagged and N=230 unflagged records PPV = 84.9% (95% CI %) NPV = 98.7% ( %) Sensitivity = 96.3% ( %) Specificity = 94.2% ( %) Problem: requires way to identify elective surgery or diagnoses present on admission
15 Hospital-level Pediatric Quality Indicators (PDIs) Indicator name Panel recommendations Internal QI Comp Report Tailored Risk Adjustment or Stratification Accidental puncture and laceration Acceptable (-) No Number and type of procedures, MDC Decubitus ulcer Acceptable (-) Acceptable (-) High risk group Foreign body left in after procedure Acceptable (+) Acceptable (+) Too rare Iatrogenic pneumothorax in neonates Acceptable (+) Acceptable (-) Iatrogenic pneumothorax, non-neonates Acceptable (+) Acceptable (-) Pediatric heart surgery mortality Acceptable (+) Acceptable (+) Specialized risk adjustment with RACHS-1 System (Jenkins et al) Pediatric heart surgery volume Acceptable (+) Acceptable (+) Postoperative hemorrhage/hematoma Acceptable (+) Acceptable (+) High risk (coagulopathy) Postoperative respiratory failure Acceptable (+) Acceptable (-) Postoperative sepsis Acceptable (-) No High risk, intermediate risk (complex) Postoperative wound dehiscence Acceptable (+) Acceptable (+) Selected infection due to medical care Acceptable (-) No High risk, intermediate risk (complex) Transfusion reaction Acceptable (+) Acceptable (-) Too rare Highlighted PDIs are closely related to existing OECD PSIs.
16 National Association of Children s Hospitals and Related Institutions (USA) assessment of PDI preventability N reviewed Preventable Uncertain PDI 1: Accidental Puncture/Laceration % 36% PDI 2: Decubitus Ulcer PDI 3: Foreign Body Left During Procedure PDI 4: Iatrogenic Pneumothorax (neonates) PDI 5: Iatrogenic Pneumothorax (nonneonates) PDI 8: Postop Hemorrhage or Hematoma PDI 9: Postop Respiratory Failure PDI 10: Postoperative Sepsis PDI 11: Postop Wound Dehiscence PDI 12: Infection Due To Medical Care PDI 13: Transfusion Reaction Scanlon MC, et al. Pediatrics 2008; 121:e1723-e1731. Highlighted PDIs were judged <50% non-preventable.
17 Recommendations for consideration Exclude indicators that require present on admission (POA) coding or exclusion of nonelective cases Postoperative physiologic or metabolic derangement Postoperative respiratory failure To minimize burden on countries, treat pediatric indicators as a separate stratum within corresponding adult indicators
18 Recommendations for consideration Postoperative hemorrhage or hematoma* Postoperative wound dehiscence* Add pediatric stratification of Accidental puncture or laceration Consider pediatric stratification of Retained surgical item or unretrieved device fragment (new name for Foreign body left in) Consider Iatrogenic pneumothorax* High PPV and preventability, but potential coding problem due to variable coding instructions in different countries using ICD-10 * Include adult/pediatric stratification
19 Reminder These indicators may still be susceptible to bias due to variation in coding intensity across hospitals Recommend continuing to collect data on mean number of secondary diagnoses among cases at risk (denominator) for adjustment
20 Postoperative pulmonary embolism or deep vein thrombosis, 2009 Source: OECD Health Care Quality Indicators Data 2011 (OECD).
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