Implementation of the Joint Federal Committee’s Quality Assurance Guideline for Premature and Full-Term Neonates

The Allocation of Newborn Infants by Hospital Care Level in Germany

Vulnerable neonates (NN) (for example, those with very low birth weight or severe malformations requiring treatment) achieve better medical outcomes when treated in hospitals with high structural quality and high patient volumes (1). The minimum standards (staff and equipment) that need to be met by maternity hospitals in Germany, depending on hospital care level (CL), are defined by the measures in the German Joint Federal Committee’s (Gemeinsamer Bundesausschuss, G-BA) quality assurance guideline for premature and full-term neonates (Qualitätssicherungs-Richtlinie Früh- und Reifgeborene, QFR-RL) (2).

The aim of this analysis is to provide a current update on the implementation of the guideline (QFR-RL), which came into force in 2006. Focus was placed on NN that were born in a CL that was too low for them.

Methods

The analysis is based on DRG statistics compiled by the Data Research Center of the German Federal Statistical Office. These statistics consist of hospital billing data and include a full annual survey of all inpatient cases involving statutory or private health insurees in Germany that received hospital treatment billed according to the DRG remuneration system. The observation unit is made up of all NN recorded in 2020. The information on CL of the hospital providing care was added to the DRG statistics using structured quality reports (3) and matched using a variable available in both data sets and consisting of institution ID and location. A full description of the dataset can be viewed online (4). Only anonymous data were analyzed. In order to determine the minimum CL in which, according to the QFR-RL, the NN should have been born in a risk-adapted manner, the allocation criteria described in the guideline were operationalized for the respective perinatal CL and an indication of risk-adapted CL was generated for each child according to the QFR-RL.

Results

For 2020, we identified 728 234 NN born in 659 hospitals (CL 1: 45.19% [329 102], CL 4: 32.20% [234 456], CL 3: 13.46% [98 022], CL 2: 9.15% [66 654]). According to the QFR-RL, 8130 NN were born in a CL that was too low for them (Table), 5518 (67.87%) of these in a CL 4 hospital. A total of 2.94% (n = 239) of the NN allocated to an inappropriately low CL had a birth weight of < 1250 g (corresponding to 4.89% of NN with a birth weight < 1250 g), of which 69 NN were born in CL 4. The majority of NN allocated to an overly low CL could be discharged from the center in which they were born: 711 (82.39%) from CL 2, 1495 (85.48%) from CL 3, and 5082 (92.10%) from CL 4. The median time to transfer of NN allocated to an overly low CL was: 1.34 days (IQR = 1.1) in CL 4, 3.14 days (IQR = 1.2) in CL 3, and 5.35 days (IQR = 1.4) in CL 2. A total of 79 (0.97%) NN that, according to the QFR-RL, had been born in a hospital with an overly low CL also died in that hospital. Of all NN, 1341 (0.18%), 1135 (0.34%), 73 (0.11%), 56 (0.06%), and 77 (0.03%) died in CL 1, 2, 3, and 4, respectively.

Table

Characteristics of 8130 neonates born at a hospital with an inappropriately low level of care according to the QFR guideline

Discussion

According to our analysis, in 2020, 98.88% of NN (n = 720 104) were born in a care level that fulfilled the minimum requirements set out in the QFR-RL. Thus, risk allocation works well in the vast majority of cases. However, 8130 NN (1.12%) were not born in a hospital appropriate to their risk profile according to the QFR-RL and were thus exposed to potential undertreatment. For the almost 10% (n = 763) of NN that were allocated to an overly low CL and that needed to be transferred, a delay in care could likely have been avoided with correct allocation. It was not possible to analyze whether these cases represent urgent cases (immediate need for care and transfer to an appropriate CL, according to the QFR-RL, unjustifiable from an obstetric point of view) or denials of admission due to lack of capacity. In order to avoid care at an overly low CL, it is important to ensure that admission capacities are sufficient. At the same time, studies describing the causes of past incorrect allocation and developing solution approaches are lacking. The current health policy discussion on the reorganization of perinatal care is calling for a two-tier structure: a specialized CL and a basic care level (comparable to the current CL 1 and 4). The distribution of NN in 2020 already resembles a care structure of this kind. One limitation worthy of mention is that not all selection criteria of the G-BA’s QFR-RL could be operationalized using DRG statistics, for example, gestational age. It was also not possible to link the mother’s data with that of her infant, which could have led to an underestimation of infants allocated to an overly low care level. Whether there were also cases in which it was not possible to assess care needs prenatally could no longer be retrospectively determined based on the DRG data. A comparison to mortality rates among vulnerable NN born in centers that were suitable for them is lacking. Therefore, we are unable to make any statement as to whether there is a quality-of-care problem.

Jan Hoffmann, Angela Kribs, Martin Dübbers, Carsten Hagenbeck, Nadine Scholten

Institute of Medical Sociology, Health Services Research, and Rehabilitation Science (IMVR), Faculty of Human Sciences and Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany (Hoffmann, Scholten); [e-mail]; Department of Pediatric Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany (Kribs); Pediatric Surgery, Department of General, Visceral, Cancer and Transplantation Surgery, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany. (Dübbers); Clinic of Gynecology and Obstetrics, Medical Faculty, University Hospital Düsseldorf, Heinrich Heine University, Düsseldorf, Germany

(Hagenbeck)

Conflict of interest statement
The authors declare that no conflict of interest exists.

Manuscript received on 23 October 2023, revised version accepted on 16 May 2024.

Translated from the original German by Christine Rye.

Cite this as:
Hoffmann J, Kribs A, Dübbers M, Hagenbeck C, Scholten N: Implementation of the Joint Federal Committee’s quality assurance guideline for premature and full-term neonates—the allocation of newborn infants by hospital care level in Germany. Dtsch Arztebl Int 2024; 121: 608–9. DOI: 10.3238/arztebl.m2024.0108

References

1. Watson SI, Arulampalam W, Petrou S, et al.: The effects of designation and volume of neonatal care on mortality and morbidity outcomes of very preterm infants in England: retrospective population-based cohort study. BMJ Open 2014; 4: e004856

2. Gemeinsamer Bundesausschuss: Richtlinie des Gemeinsamen Bundesausschusses über Maßnahmen zur Qualitätssicherung der Versorgung von Früh- und Reifgeborenen gemäß § 136 Absatz 1 Nummer 2 SGB V in Verbindung mit § 92 Abs. 1 Satz 2 Nr. 13 SGB V: (Qualitätssicherungs-Richtlinie Früh- und Reifgeborene/QFR-RL) 2020.

3. Gemeinsamer Bundesausschuss: Qualitätsberichte der Krankenhäuser. www.g-ba.de/themen/qualitaetssicherung/datenerhebung-zur-qualitaetssicherung/datenerhebung-qualitaetsbericht/ (last accessed on 29 January 2024).

4. Forschungsdatenzentrum des statistischen Bundesamtes: DRG-Statistik 2020: Datensatzbeschreibung. https://forschungsdatenzentrum.de/sites/default/files/drg_2005-2022_on-site_dsb.pdf (last accessed on 29 January 2024).