v2.3 July 2013 Specifications for Unexpected Newborn Complications (UNC) v2.3 Introduction/ Overview Figures 1-4: Flow Charts for Denominator and Numerator calculations Table 1: Total, Severe and Moderate UNC rates; Statewide, California 2011 Figure 5: Frequency Distribution of UNC (Total), for all California Hospitals 2011 Table 2: UNC Sub-measures to help interpretation and drive quality improvement activities Appendices 1-6 (ICD-9 Code tables, see Excel file)

v2.3 July 2013 Unexpected Newborn Complications (UNC): Overview (1) aka NQF 716: Healthy Term Newborn Key maternity outcome measure – The most important childbirth outcome for families is a healthy baby. UNC is the first well-balanced and validated measure to address this gap. – Also serves as a balancing metric for maternal measures such as NTSV CS, 3 rd /4 th degree lacerations, episiotomy and early elective delivery rates Denominator: Term infants without “pre-existing conditions”: – Exclusions: preterm, <2500gm BWt, multiple gestations, all congenital anomalies (“big or small”), other fetal conditions, and exposures to maternal drug use Numerator: a set of either short or long term complications that would significantly concern for the mother/family. – Identified by focus groups of neonatologists and families – Grouped into severe and moderate levels – An additional principle is the identification of cases of family separation /disruption: term babies that require neonatal transport to another facility or baby complications that require a stay longer than their mother

v2.3 July 2013 Unexpected Newborn Complications: Overview (2) Utilizes administrative data sets with unique safeguard strategies for both under- and over-coding – Combines diagnosis codes and procedure codes and Length of Stay Under-coding: – If a baby is missing a diagnosis code (e.g. HIE/asphxia), the case is still likely to be identified using procedure codes (head cooling, intubation, resuscitation) or a neonatal LOS > mother LOS – A baby would also be included if it has a very long LOS without any diagnosis codes to explain it after excluding drug withdrawal, jaundice, social reasons (adoption, placement, homeless) Over-coding: – Certain codes may not truly represent serious morbidity such as Sepsis with an under 4 day LOS (most likely represents “r/o sepsis” rather than true sepsis), or “other birth injuries” that do not keep the baby longer than the mother

v2.3 July 2013 Unexpected Newborn Complications: Overview (3) Advantages (over other approaches to neonatal morbidity) No administrative data source for term baby NICU admissions – In any case, term NICU admissions can include observation cases and those with minor issues and local protocols vary for many conditions Composite Measures that use ICD-9 codes alone are subject to over or under stating the true morbidity – For the AHRQ Birth Injury measure (PS-17), more than 2/3 of the cases identified belong to the non-specific birth injury codes (767.8, 767.9) – Many California hospitals have no reporting of codes or 768.6, birth asphyxia, presumably for medical-legal reasons Can be calculated with administrative data alone Disadvantage Requires a linked set (that provides the proper checks and balances) – Baby Discharge Diagnosis file (ICD-9 codes, LOS and Disposition) – Birth Certificate (Birth Weight, Gestational Age, Method of delivery) – Linkage algorithms well established by CMQCC

v2.3 July 2013 Revised Specifications v2.3 NQF #716: Unexpected Newborn Complications (aka Healthy Term Newborn) Figure 1: Denominator Inclusions BWt ≥2.5kg? Hospital Discharge Diagnosis File Use Birth Certificate or Medical Record: Birthweight Not in Measure Population Yes GA ≥37wks? BWt ≥3kg? GA Unknown Yes GA Unknown No Starting Denominator Use Birth Certificate or Medical Record: Best Obstetric Estimate of Gestational Age Use Birth Certificate or Medical Record: LMP-based Gestational Age Use Birth Certificate or Medical Record: Birthweight Singleton Livebirth? No or Unknow n Screen for ICD-9 Diagnosis Codes V3000 or V3001 Yes No or Unknow n These represent back- up criteria. Birth Certificate Obstetric Estimate of GA usually is present for >99% of cases, and then these two steps may be omitted Note: ICD9 and DRG codes alone are very poor at identifying term infants. Therefore, the GA from BC is used.

v2.3 July 2013 Revised Specifications v2.3 NQF #716: Unexpected Newborn Complications (aka Healthy Term Newborn) Figure 2: Denominator Exclusions Congenital malformations? Starting Denominator Use Patient Discharge Diagnosis Data, examining both Primary and Other Diagnosis fields for specific ICD-9 Codes defining a wide array of Fetal Malformations and Genetic Disorders (see Appendix 2, Group A) Exclusions No Other Fetal Conditions? Maternal Drug Use? No Yes Final Denominator Use Patient Discharge Diagnosis Data, examining both Primary and Other Diagnosis fields for specific ICD-9 Codes defining an array of other Maternal and Fetal Conditions (see Appendix 2, Group B) Use Patient Discharge Diagnosis Data, examining both Primary and Other Diagnosis fields for specific ICD-9 Codes defining an array of Maternal Drug Use Diagnoses (see Appendix 2, Group C) Yes In summary, the Final Denominator excludes most serious fetal conditions that are “preexisting” (present before labor), including: prematurity, multiple gestations, poor fetal growth, congenital malformations and genetic disorders, other specified fetal and maternal conditions and maternal drug use.

v2.3 July 2013 Revised Specifications v2.3 NQF #716: Unexpected Newborn Complications (aka Healthy Term Newborn) Figure 3: Numerator Inclusions: Severe Complications Neonatal Transfer? Use Patient Discharge Diagnosis Data: Disposition Code for Transfer to Higher Level of Care Numerator: Severe Complications No 5’ or 10’ Apgar ≤3? Severe ICD-9 Code? Sepsis and LOS >4 days? No Yes Starting Population for Moderate Complications Analysis Use Birth Certificate or Medical Record: Apgar Score at 5 minutes or 10 minutes ≤3 Use Patient Discharge Diagnosis Data, examining both Primary and Other Diagnosis and Procedure fields for specific ICD-9 Codes defining a array of specific Severe Complications, included selected codes from the categories of: Birth Injuries, Hypoxia/Asphyxia, Shock/Complications, Respiratory Complications/Procedures, Infections, Neurologic Complications. (see Appendix 3, Groups 3A thru 3I) Use Patient Discharge Diagnosis Data, examining both Primary and Other Diagnosis fields for the specific ICD-9 Code defining sepsis but also requiring a neonatal Length of Stay >4 days. (see Appendix 3, Group 3J) Neonatal Death? Use Patient Discharge Diagnosis Data: Disposition Code for Death No Final Denominator Yes No

v2.3 July 2013 Revised Specifications v2.3 NQF #716: Unexpected Newborn Complications (aka Healthy Term Newborn) Figure 4: Numerator Inclusions: Moderate Complications LOS >4d CS or LOS >2d Vag? Use Patient Discharge Diagnosis Data for LOS and for ICD-9 Diagnosis Codes V3000 (vaginal birth) or V3001 (Cesarean birth) Numerator: Moderate Complications Yes Moderate Comps (with LOS)? LOS>5d? Jaundice or Social codes? No Yes No Starting Population for Moderate Complications Analysis Use Patient Discharge Diagnosis Data to determine LOS Use Patient Discharge Diagnosis Data, examining both Primary and Other Diagnosis and Procedure fields for the specific ICD-9 Code defining Neonatal Jaundice or Social Indications for prolonged hospitalization. (see Appendix 5, Groups A thru C) Moderate Comps (No LOS)? Use Patient Discharge Diagnosis Data, examining both Primary and Other Diagnosis and Procedure fields for specific ICD-9 Code defining a specific Moderate Complication, that do not require a prolonged LOS (see Appendix 4, Groups A thru C) No Yes Use Patient Discharge Diagnosis Data, examining both Primary and Other Diagnosis and Procedure fields for specific ICD-9 Codes defining a array of specific Moderate Complications, included selected codes from the categories of: Birth Injuries, Hypoxia/Asphyxia, Shock/Resuscitation, Respiratory Complications/Procedures, Infections, Neurologic Complications. (see Appendix 4, Groups D thru H) Not in Numerator No Yes No

v2.3 July 2013  Unexpected Newborn Complications (Total): (rate per 1,000 livebirths) (Severe Complications Numerator + Moderate Complications Numerator) x 1,000 Final Denominator California state-wide rate in 2011: 39.3 per 1,000 births  Unexpected Newborn Complications (Severe): (rate per 1,000 livebirths) (Severe Complications Numerator) x 1,000 Final Denominator California state-wide rate in 2011: 23.1 per 1,000 births  Unexpected Newborn Complications (Moderate): (rate per 1,000 livebirths) (Moderate Complications Numerator) x 1,000 Final Denominator California state-wide rate in 2011: 16.2 per 1,000 births NQF #716: Unexpected Newborn Complications (aka Healthy Term Newborn, Revised Specifications) Table 1: Final Measure Calculations

v2.3 July 2013 Fig. 5: Frequency Distribution of UNC Measure In California Hospitals ( ) California Mean = 36.0/1,000 (3.6%) Significant variation noted in both large and small hospitals

v2.3 July 2013 Revised Specifications NQF #716: Unexpected Newborn Complications (aka Healthy Term Newborn) Table 2: Sub-Measure Calculations An additional feature is the ability to calculate several sub-measures to direct Quality Improvement efforts. These “buckets” include like-diagnoses from both severe and moderate categories. Hospital level comparisons show significant variation in these categories. This Sub-measure analysis allows hospitals to focus on specific care practices to drive QI. See Appendix 6 for details on the Sub-Category groupings.

v2.3 July 2013 Unexpected Newborn Complications: Validation Studies Face Validity: – In a comparison trial for neonatal morbidity by gestational age tracked very closely to NPIC (major East Coast perinatal data set) analysis using NICU admissions and major complications (in press) Formal Reliability Testing – NQF requirement using RAND statistical tools – Tests ability to discriminate among hospitals – Good is 0.8, excellent is 0.9 – Mean Reliability among 220 California hospitals =0.92 Stability within a hospital over time – Tested for 3 6-month periods with minimal variation noted in >90% of California hospitals