Download Assessment of the safety and quality of hospital care for

Ministry of Health of Montenegro
UNICEF Montenegro
Assessment of the safety and quality of hospital care for
mothers and new-born babies in Montenegro
Plan of actions to improve the quality of perinatal care
Report prepared by
Audrius Maciuleavicius, neonatologist, Kaunas, Lithuania
and Stelian Hodorogea, obstetrician, Chisinau, Moldova
SITES VISITED:
Cetinje, Kotor, Berane, Podgorica, Nicsic
DATES OF VISITS:
5-14 December, 2011
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Content list
1. Background and objectives
2. Agenda, methods and assessors team
3. Results
4. Conclusions and recommendations
5. References
6. Annexes
2
List of abbreviations
IMPAC - Integrated Management of Pregnancy and Childbirth
MoH – Ministry of Health
MNC - Maternal Child health
MN - Mother and Newborn
MW - Midwife
OB/GYN - Obstetrician gynaecologist
CS – Caesarean Section
UNICEF- The United Nations Children’s Fund
VE – Vacuum extractor/extraction
WHO - World Health Organization
QoC – Quality of care
VBAC – vaginal birht after cesarean
CTG – cardiotocography
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1. Background and objectives
Montenegro is a country with low Infant Mortality Rate (5.7 per 1,000 live births in 2009
as per the Public Health Institute Statistics Yearbook). Neonatal Mortality accounts for about
80% of all deaths (2008, UNICEF Situation Analysis). Birth asphyxia is one of the principal
causes of death. Montenegro has a good network of Primary Health Care (PHC) and hospital
facilities. The PHC network has been strengthened through a World Bank supported project.
The country spends around USD 1,100 (2007, UNICEF SitAn) per capita and a national
health insurance system is functional since 2004. Total Health Expenditures (THE) account
for about 9% of GDP, while Government expenditures represent 5% of GDP which is close to
EU averages.
The country has implemented regionalization of perinatal care which is constituted by one
tertiary National Obstetrics and Gynecology Hospital in Podgorica and the Neonatal Intensive
Care Unit (NICU), which is a separate entity as part of the national pediatric hospital. There
are 8 Level 1-2 maternity hospitals/wards in the country that have between 233 and 850
deliveries per year and other 4 very small delivery units (with 3, 10, 55 and 126 deliveries per
year) with no explicit distinctions between these two levels.
The National Clinic of Obstetrics and Gynecology in Podgorica is not implementing many
evidence-based standards in perinatal care, including the Baby Friendly Hospital Initiative
(BFHI) steps. There is no rooming-in (all newborns are placed in a separate unit and are
brought for breastfeeding to their mothers every 3 hours). Early initiation of breastfeeding is
inadequate (newborns are put on mothers breast just for few minutes after delivery being
separated afterwards for about two hours). There is no breastfeeding on demand and bottlefeeding is a wide-spread practice and even breastfeed babies are supplemented by bottlefeeding during the 3 hours intervals. There is no clear policy on breastfeeding, nor maternity
hospital’s staff is systematically providing support to mothers to initiate breastfeeding or
address problems with lactation.
The MoH and the management of the hospital are eager to change the situation and suggested
building new hospital premises as one of the key pre-conditions required for the
implementation of BFHI. The maternity ward has little space for the number of deliveries
(3,200 per year). There are only two delivery rooms (4 beds) which do not allow for privacy
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and family centered care. There are about 3-4 women in most post-natal rooms which (based
on opinion of local staff and management) poses problems to practice rooming in.
Overall the perinatal system is rather fragmented, as there is no satisfactory exchange of data
and information with the NICU, nor there are joint reviews of performance. Perinatal care in
general is over-medicalized as there is a very high reported cesarean section rate, very high
proportion of induced and augmented deliveries, persistent use of outdated routine procedures
(enema, shaving, liberal episiotomies). Besides rooming in and early, exclusive breastfeeding
on demand, many other effective, WHO recommended technologies are not used: partnership
and continuous support during labor, promotion of ambulation and free positions,
discouraging horizontal delivery positions and routine directed pushing, application of active
management of third stage of labour and partogram use.
There are no national guidelines / protocols as well as local protocols and algorithms for
management of obstetrical and neonatological complications and emergency situations.
Under the supervision of the UNICEF office and in close consultation with the Ministry of
Health of Montenegro and the management of the National Hospital of Obstetrics and
Gynecology, with the support of the international experts, it was planned to develop a project
proposal focused on improvement of perinatal care, in line with WHO recommendations and
evidence based medicine (EBM).
In order to develop the proposal:
1. Self-administered questionnaire was elaborated and sent to all facilities offering
maternity services. The questionnaire included data on perinatal mortality and
morbidity indicators, main obstetrical procedures and referral issues, as well as
information on infrastructure, available equipment and staffing.
2. In the period 5-14 December, an assessment of the quality of hospital care for mothers
and newborns in a sample of maternity units in Montenegro, was conducted. The
objectives of the assessment were:
a. to identify critical issues concerning the quality of MNC care in selected hospitals;
b. to suggest actions to improve MNC quality at both central and health facility level,
taking into account the underlying factors influencing quality of care;
c. to provide an opportunity for a national team of assessors to get familiar with the
assessment tools and methods.
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The assessment exercise was also meant to contribute to introducing the concept of peer
review and quality improvement in hospitals for managers and health professionals.
2. Agenda, methods and assessors team
The agenda of the assessment visits, preparatory work and debriefing is reported in Annex 1.
The team used the following tool: Tool for assessment of quality of care for mothers and
newborn babies in hospitals, developed by WHO Regional Office for Europe, with technical
support from WHO Collaborating Centre in MCH in Trieste, Italy. The tool was translated
into Montenegrin and distributed in advance to team of local assessors.
The assessment tool and methods were based on the experience gained in the use of the
paediatric assessment tool, which was developed in 2001 by WHO and then widely used
globally, including in the European Region, and on the experience gathered by WHO
Regional Office for Europe in the implementation of Making Pregnancy Safer programme
and Effective Perinatal Care training package. Reference standards are represented by the
WHO Pocket Book on Hospital care [1], by the IMPAC package of guidelines [4-7] and by
the WHO Regional Office for Europe Effective Perinatal Care training package [8,12]
Questions in the tool for assessment maternity practice which were not reflected in abovementioned packages were formulated on the basis of best latest available evidence.
The informing principles of the tool are the following: be based on evidence and
internationally accepted standards; be capable to guide the collection of valid information in
key areas; be user-friendly; be able to stimulate the involvement of hospital staff in
identifying problems and possible solutions.
The tool is intended to allow a problem based action-oriented careful assessment of all the
major areas and factors which may have an impact on QoC such as infrastructure, supplies,
organization of services, and case management, focusing on the areas that have been shown to
have the greatest impact on maternal and newborn mortality and serious morbidity, as well as
on maternal and neonatal wellbeing.
The items included in the assessment were chosen also to provide a comprehensive
assessment of the four dimensions of QoC as identified by the WHO European Strategic
Approach for making pregnancy safer: 1) be based on scientific evidence and cost/effective;
2) be family centered, respecting confidentiality, privacy, culture, belief and emotional needs
of women, families and communities; 3) ensure involvement of women in decision-making
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for options of care, as well as for health policies; 4) ensure a continuum of care from
communities to the highest level of care, including efficient regionalization, and
multidisciplinary approach [11].
A briefing on aims and methods of the assessment and on the assessment tool was held at
Podgorica Clinical Centre with the national team of assessors (Annex 2) and Ana Zec,
UNICEF representative.
In all five sites, the assessment started with the team of assessors presenting scope aims and
methods of the assessment as well as the team of the assessors to the hospital director and
heads of relevant services (maternity, neonatology,) including head nurses and midwives.
During the visit, the assessment teams discussed the main data (patient flow, available
outcome and process indicators, infrastructure including availability of equipment, drugs and
supplies) from the self-administered questionnaires which had been sent to hospital managers
and were completed by the hospital staff.
The assessment included a visit in both maternity and neonatal wards, delivery rooms and
nursery; examination and discussion of selected cases among the admitted patients;
examination and discussion of selected clinical records; interviews with health professionals
and mothers. The assessors met at the end of the working day to collect and discuss the main
findings and to prepare the final synthetic presentation of the main findings (positive aspects
of care and those that should be improved) to the local health professionals.
Participation of the expected local professionals to the briefing and debriefing sessions and
their collaboration throughout the visit were very satisfactory in all sites.
After the visits were completed, the international and national teams met together to assemble
the information, discuss findings and recommendations, and prepare a presentation for
debriefing meeting (see Annex 5 and 6). A debriefing session was held with representative of
UNICEF and representatives from the maternity hospitals, which were assessed.
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3. Results
The main findings for the maternities and neonatal wards are reported in Table 1. Scores
represent the average score of the items included in the respective areas. For each areas
assessed, a list of main detected problems is presented.
Table 1. Summary of assessment of quality of maternal and neonatal care and most
relevant problems identified.
Areas
Main problems
A
1
B
1
C
1
D
1,5
E
1
Substandard clinical records keeping
Data not systematically analysed and used to
develop solutions / recommendations to
improve quality of care
1.a Hospital
health statistics
Absence or underuse of monitoring forms
(partogram, temperature control, post-partum
check lists)
Inaccurate data reporting and local use
1.b Drug
availability
2
2
2
3
2
1
1
2
2
2
1.c Equipment
and supplies
1.d Availability
and use of
laboratory
support
Lack of essential equipment for new-born
care (Ambu sacs and masks, aspirators,
heating sources)
In some facilities absence of devises for
assisted vaginal delivery and paper for CTGs
2
2
2
3
2
1
2
2
2
2
1.e Basic
infrastructure
Places for hand washing
Operation theatre far from delivery ward
Periodical electricity cuts
General hospital
conditions
(avarage scores)
Maternity
ward/nursery and
neonatal ward
1,5
1,5
2
2.5
2
No rooming-in in most facilities
0,5
0,5
1
0,5
2
Some key basic low cost equipment/supply
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not everywhere available (wall clock,
thermometer for room temperature, paper for
CTG, towels and antiseptic for hand-washing)
Visits of relatives not allowed
No individual delivery rooms: there are
separate spaces for first and second stage of
labor in all facilities
No conditions for labor companionship
Normal labour
and delivery
0,5
0,5
0,5
1
0,5
No national clinical guidelines and no local
protocols on care in normal birth
Non-effective routine procedures practiced
(enema, shaving, episiotomy in primiparas or
preterm labour, directed pushing)
Effective technologies not used (partners not
allowed, ambulation and movement and
active management of third period not
practiced)
Non-horizontal delivery positions are not
promoted and no conditions organized for
this.
Excess of medicalization (sedatives,
spasmolytics)
Lack of presence and use of basic clinical aids
(clocks, room thermometers and newborn
thermometers)
Privacy and confidentiality not respected
Labour progress and fetal well-being not
monitored according to partogram
Vaginal examinations are conducted without
indications, at short time intervals
Warm chain is not properly maintained
Over-use, in most cases without indications,
of labour induction and augmentation
No check-list for monitoring of women after
delivery
9
Caesarean section
and postoperative
care
1
1
1
2,5
1
No national clinical guidelines and no local
protocols on indications and procedures
Very liberal indications for caesarean section
and very high rate of caesarean section as a
result.
Regional anaesthesia underused
Antibiotic - prophylaxis not according to
evidences and international recommendations
Under use of vaginal operative deliveries,
over-use of labour stimulation and
inappropriate monitoring during labour that
probably increase CS rate.
Insufficient communication with women
Informed consent is not operational
New-borns are separated from mothers
Case management
and maternal
complications
1
1
2
2,5
1
No national clinical guidelines and no local
protocols / algorithms based on evidence on
emergency care and management of
complications in most facilities
Wide differences of management of maternal
complications between different doctors and
different facilities
Over diagnosis and use of not internationally
accepted diagnostic and management criteria
for preeclampsia, obstructed labor, preterm
labor.
Over treatment: inappropriate use of drugs
and use of not effective drugs (tocolisis at 3536 weeks, diuretics for preeclampsia,
inappropriate use of antibiotics).
Lack of communication with patient and
families
No preparedness and lack of knowledge for
management of many obstetrical
complications (eclampsia/severe
preeclampsia, shoulder dystocia, PPROM,
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fetal distress in labour – assisted vaginal
delivery)
Routine neonatal
care
1
1
1
1
1,5
Many not evidence based interventions are
used (separation of new-borns from mothers,
routine
suction,
anthropometric
measurements, bathing, swaddling in many
places)
Low preparedness for resuscitation, lack of
skills
Warm chain not respected (absence of staff
knowledge, measures not implemented (warm
delivery room, skin to skin contact) and
temperature not controlled)
Early and exclusive breastfeeding not
promoted
Inappropriate use of Apgar score and overdiagnosis of encephalopathy
Communication with mothers and families to
be improved
NICU
na
na
na
1
na
No national clinical guidelines and local
protocols based on evidences
Frequent use of drugs and interventions of
unproven effectiveness during the treatment
of sick new-borns in NICU
Non controlled O-therapy
Inadequate infection control measures
Monitoring charts of newborns admitted in
NICU not filled up in a proper way
Poor communication between obstetricians
and neonatologists
Case management
and sick newborn
care
1
1
1
1
1
No national clinical guidelines and
protocols based on evidences
local
Mothers not involved in treatment of sick
newborns
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Calculation of feeding needs of sick newborns
not properly figured out
Frequent use
of drugs
of unproven
effectiveness during the treatment of sick
newborns
Emergency care
No national guidance for the referral system
1
1
2
2,5
1
No national clinical guidelines and no local
protocols/algorithms based on evidence
No sets for obstetrical emergencies
(preeclampsia/eclampsia, post-partum
haemorrhages)
In some cases structural problems to
transport patient to delivery or operating room
Lack of documentation / monitoring forms for
emergencies
In many facilities no 24 coverage with
obstetricians and anaesthesiologists
Infection,
prevention and
supportive care
0,5
0,5
0,5
1,5
0,5
Insufficient infection control
Lack of fully equipped places for
washing
hand-
Excess of inappropriate procedures (enema,
shaving, restrictions for partners and visitors,
use of masks and gowns)
No individual delivery rooms and rooming in
not practiced in most facilities
Insufficient communication with women
Lack of written information
Monitoring and
follow up
1
1
1
1
1
Absence of documentation forms for most
emergencies, obstetrical complications and
procedures (new-born resuscitation, assisted
vaginal delivery, shoulder dystocia,
preeclampsia)
Monitoring actions are not appropriately
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recorded
For some severe conditions monitoring not
frequent enough
Guidelines and
team work
0
0
0
1
1
There is no midwife/nurse charts (thermal
control, partogram or vital signs of women
after delivery)
No national and local protocols and
algorithms (only some examples of local
protocols on obstetric emergencies in one
facility)
Case management varies among doctors and
facilities
Lack of internal audit and team work
Access to
Hospital
2
2
2
2
2
No continuity of information on offered care
from peripheral level to central hospital
Women poorly informed on a danger signs
of pregnancy complication and time to
hospitalization
Irrespective of the specificities of each area of care (obstetric, midwifery care, neonatal care,)
the assessment in the four hospitals identified several common positive areas of MCH
maternity care and a number of critical aspects to be addressed:
Areas that received a high overall score:
1. Hospital support systems and infrastructure
a. Infrastructure
All visited maternity and neonatal units are currently in a very good physical condition
or are in the process of renovation (Podgorica Maternity Unit) having good sanitary facilities,
permanent electricity and water supply (cold and warm) (Annex 7). There are periodical
short-cuts of electricity supply (mostly in peripheral, small facilities), but very infrequently.
Existing space and rooms in most maternity units are more than sufficient to organize
necessary number of individual delivery rooms, postpartum rooming-in and sufficient space
for neonatal facilities.
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The only exception is the necessary number of individual delivery rooms in Podgorica
Clinical Centre. It is calculated that there should be one delivery room for 350-400 deliveries
per year: current plan of renovation of Podgorica Maternity Unit includes only 5 individual
delivery rooms that is not sufficient for 3161 deliveries that were assisted here in 2011.
Between 7 and 8 individual delivery rooms should be organized in this facility to assure
partnership and implement and respect infection control measures.
It is necessary to mention, that perceived lack of space in post-partum rooms (3-4
women in one room) is not a barrier to practice effectively rooming in and keep newborns
with mothers. The only additional equipment to be placed in post-partum rooms are tables for
neonates.
b. Availability and use of laboratory support
Laboratory support is available and very well organized: all essential lab data can be
obtained (depending on the level of facility) in a reasonable time-frame and are reliable
(Annex 7).
c. Drug availability
Facilities have a good supply of essential medications necessary to manage
complications and offer treatments in obstetrics and neonatology. Patients do not have to
procure necessary medications. Few essential drugs are not periodically or permanently
available (for ex. Misoprostol, i/v antihypertensives (Labetalol or Hydralasine)).
The main challenge in this field is overuse or still continuous use of non-evidence
based treatments and drugs including spasmolitics and sedatives in labor, hormones,
Diazepam and diuretics in preeclampsia, MgSO4 and many days of beta-mimetics for preterm
labor even at gestations more than 34 weeks, Mifepristone for labour induction, FFP in
neonatal NICU, overuse of broad-spectrum antibiotics of reserve etc.
2. Access to Hospital Care
It not seems to be important financial, organizational, transport and other king of
barriers to obtain hospital care in facilities of Montenegro.
Main problems in this area include: no agreement on volume and content of
appropriate pre-referral treatment for pregnant women and stabilization of sick newborns,
when indicated; quality and volume of information of referral notes (stating the condition,
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reason for referral and any treatment given). Also, during ANC women are not fully informed
on a danger signs of pregnancy complication and time and place to hospitalization.
Ten priority areas that received low over-all scores and should be improved are:
1. Hospital and national health statistics
There is a computerized system for personal medical data recording on national level;
paper based medical records and journals for documenting patient flow exist in all facilities.
Unfortunately, with few exceptions, data collections are mainly used for reports
generation, rather to analyze the situation (identifying causation/correlation and making and
implementing recommendations and solutions how to improve organization and quality of
maternity services). In the discussions with health care providers and managers, it was
mentioned that data are sent and aggregated by National Public Health Institute. Afterwards,
these statistical data are not analyzed and not used for the quality improvement activities at
national and local level. For example, staff caring after LBW and preterm newborns, do not
know survival rates as well as quality of survival of babies at different gestational ages or
birth weights; the last analysis of activity was done and presented to health professionals in
2007 (!) with no proposal / solutions how to improve quality and organization of care as a
final result.
Also, it seems that provided statistical information is not always correct. In a facility
with reported rate of CS of 20%, the real frequency of operative abdominal delivery,
according to delivery log journal seems to be almost two times higher (16 cesarean sections
out of 39 deliveries – 41%).
2. Equipment and supplies
Visited maternities are quite well equipped with incubators, heating sources for newborns
and ventilators; facilities have sufficient number and quality of beds for mothers and
neonates, but outdated, old-fashioned birthing chairs.
All evaluated facilities are not adequately equipped and prepared to offer evidence based,
WHO recommended intra-partum and postpartum care and assure safety for mothers and
newborns. There are no properly furnished individual delivery rooms including birthing chairs
– transformers for delivery, sufficient number of tables for resuscitation of newborns with
heating sources, necessary number of weighing-machines, wall and electronic thermometers,
wall clocks; equipment for pain relief and promotion of partnerships: gymnastic balls, chairs
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for alternative delivery positions, tables and chairs for partners; sets for emergency obstetric
care etc. In some facilities, delivery and neonatal wards are not adequately equipped with all
necessary essential equipment for newborn resuscitation, including Ambu bags and masks,
single use catheters, aspirators, laryngoscopes etc.
Again, it should be mentioned, that absence of some equipment in maternity units should
not be regarded as a potential barrier for practicing EBM, WHO recommended technologies.
For example, non-horizontal positions in the second stage of labor can be promoted and
practiced despite absence of modern birthing chairs (transformers), although existence of such
transformers is desirable in the delivery rooms.
3. Maternity ward/nursery and neonatal ward
As mentioned above, there are no individual delivery rooms in all visited maternity wards:
separate rooms for management of first stage of labor and for delivery of newborn are used
instead. Because of this, there is no possibility to allow companions during labour and to
promote effective intra-partum technologies like ambulation and movement, non-horizontal
positions, skin to skin contact and early breastfeeding and bounding; to respect privacy and
dignity of pregnant women and members of their families.
With few exceptions, there are separate postpartum rooms for mothers and separate
neonatal wards even for healthy babies: so, no rooming-in is practiced in most visited
facilities. Family members, visitors are not allowed to post-partum ward and to sick
newborns. Mothers also are not allowed to care after healthy, as well as after sick newborns.
4. Care for normal labor and delivery
There are no individual delivery rooms and possibility for companionship in labor. Many
outdated and non-evidence based technologies continue to be used during intrapartum care,
including:

Routine shaving

Routine enema

Delivery in lithotomy position

Routine directed pushing

Liberal use of episiotomy (almost routine in some facilities - up to 80%)

Routine use of masks, caps in labour ward
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At the same time, a number of evidence based, WHO recommended, effective technologies
are not practiced:

Partnership and continuous one-to one support

Ambulance and vertical positions on the first stage of labour

Alternative methods for pain management like massage, changing positions, water
immersion and shower

Free delivery positions are not used and promoted

Partograph is not used for monitoring and decision making in labor

Monitoring of fetal wellbeing in labor often is substandard and not properly recorded

Warm chain is not properly maintained

Active management of 3rd stage of labor is not offered

Skin to skin contact

Early breastfeeding
Preparedness for newborn resuscitation is insufficient; both from perspective of
awareness, skills, and equipment (no wall clocks, no masks for preterm babies in some
facilities, Ambu bags not always functional). Obstetrical staff (obstetricians and midwifes) are
not trained in resuscitation technics. There are no visible algorithms on newborns
resuscitation: those available are outdated. Adequate monitoring of women and baby in the
delivery room (in the first 2 hours) is not ensured.
The results of under-use of efficient, WHO recommended intrapartum technologies, are
high rate of cesarean section, very high incidence of augmentation of labor (see table in the
annex 4). Coupled with poor monitoring of fetal well-being and infrequent use of assisted
vaginal delivery, these practices lead to quite frequent cases of intrapartum asphyxia. At least
50% of full term babies that died in Podgorica Pediatric Unit suffered peripartum asphyxia.
Also, almost 800 infants up to one year receive treatment in this facility (one out of 10!).
5. Routine neonatal care
The main problem is that babies are separated from mothers immediately after
delivery and only few maternities practice rooming in Montenegro. Skin to skin contact, as a
technology to prevent hypothermia and nosocomial infection, as well as early breastfeeding
are not practiced. Babies are feed after even time intervals; milk formula is frequently used
increasing risks for lactostasis/mastitis in mothers and of infections in neonates. Quality of
promotion, information and counseling on breastfeeding and how to care after a healthy
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newborn is weak. Managers and providers are not aware about benefices of effective
promotion of breastfeeding as one of the most effective ways to improve the health of
children, as pointed at the EU Conference on Promotion of Breastfeeding in Europe on June
18th, 2004 in Dublin Castle, Ireland [16].
There is no concept of warm chain in all visited maternities: temperature in delivery
rooms is not monitored, newborns are not dried, placed skin to skin contact and covered to
prevent hypothermia, caps and socks are not wearied; instead in many facilities newborns are
swaddled, being separated from mothers. Temperature is not monitored, as recommended
after 30 minutes and 2 hours after birth; staff is not aware about normal temperature of
neonates, risks of hypothermia and necessity to respect warm chain.
A number of outdated, inefficient and even harmful routine practices continue to be
used: routine suction of nose and mouth, routine antiseptics for umbilical stamp, early
clamping of umbilical cord, routine bathing ect.
6. Cesarean section
During one decade, rate of cesarean section increased dramatically in Montenegro:
from 10 % in 2000 to almost 24% in 2010.
Figure 1
Rate of cesarean section in Montenegro
(HFA WHO Europe database)
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This situation seems to be a consequence of many underlying causes. One of them is
existence of very liberal indications for cesarean section in many facilities: staff prefers to do
caesarean section during day period to “avoid risks of surgery during night time”. As a result,
rate of caesarean section at referral level (21%), in which are concentrated most difficult
obstetrical cases is substantially lower that in many peripheral, low risk facilities (between 23
and 29%) (see Annex 4). It seems that in some facilities, CS rate is around 35-40%.
High rate of CS is also a consequence of over-use of technologies that proved to
increase risk of abdomianal delivery (“active management of labour’ that result in extremely
high incidence of augmentation, use of intrapartum CTG without clear recommnedations on
interpretation and no possibility to perform fetal blood sampling to confirm fetal distress,
almost routine labor induction at 41 weeks of pregancy) and under-use of technologies proved
to decrease risc of CS: continuous support during labor (preferably by partner); WHO
partogram with 4 hour action line; VBAC – vaginal birht after cesarean, that is succesful in
60-70% cases.
Curently, there are no national clinical guidelines and no local protocols on indications
and procedures of CS. The result is not only high rate of CS, but also use of risky procedures
(general anaesthesia predominate over regional, antibiotic - prophylaxis not according to
evidences and international recommendations), insufficient communication with women
about risks and consequences of CS, separation of approximately one fourth of babies from
mothers and resulting low acceptance of breastfeeding.
7. Case management and maternal complications
Case management of most common conditions and complications is often substandard
with respect to established international standards and recommendations. The main problems
are: failure to use international classification of diseases (hypertensive diseases, criteria for
imminent preterm delivery), over-use of drugs (including unnecessary over-medicalization
and use of potentially harmful drugs) and i.v. fluids. Outdated recommendations are used for
management of preterm labour and prelabor preterm and term rupture of membranes.
With one exception, we did not see local algorithms, not standard sets of equipment
and drugs for emergency care for main obstetrical complications: postpartum hemorrhages,
severe preeclampsia / eclampsia, severe sepsis/septic shock, shoulder dystocia, assisted
vaginal delivery. Another important quality issue is absence of clear recommendations for
intra-partum monitoring of fetal well-being and emergency actions in case of intra-partum
fetal distress.
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In general, in many peripheral level facilities, here is a very low preparedness to deal
with major obstetric emergencies, from all perspectives (awareness, knowledge and skills,
organization). Being asked about emergency measures in case of eclampsia or severe
preeclampsia, local staff offered quite strange answers: “…we do not have such cases, as
antenatal care is of very high quality’; “specialist in internal medicine is invited to prescribe
treatment for woman with preeclampsia” or “I have never had a case of shoulder dystocia”
when asked about management of this rare, but very severe complication of second stage of
labour.
The main reason for this situation is that there are no agreed national/local
protocols/guidelines for main obstetrical conditions and complications, as well as for
management of normal labor and delivery, caesarean section, care of healthy new-born. There
is not an established system of continuous medical education in the country; it seems that
medical education curricula is also outdated and should be changed to correspond to
international requirements.
A big number of necessary monitoring forms and check-lists are not produced and
used (partograph plots for monitoring of first stage of labour and fetal well-being, room and
newborn temperature, monitoring of women after normal labor and cesarean section,
monitoring of women with obstetrical complications, check list for emergencies like vacuumextraction or maneuvers in cases of shoulder dystocia).
Continuity of care and team approach is another burning issue: neonatologist is not
involved in discussion for options of case management of obstetrical conditions (like
preeclampsia, IUGR, PROM, imminent preterm delivery) and is not informed about use of
corticosteroids or appropriate antibiotics for prevention of early neonatal sepsis; obstetrical
staffs is not trained in neonatal resuscitation.
8. Case management and sick newborn care
As for healthy neonates, mothers are not allowed to care after sick newborns: they are
separated from mothers, do not receive breast milk for feeding; instead formula and pacifiers
are overused.
A number of ineffective and even dangerous practices are used in neonatal ward when
caring on sick babies: oxigenotherapy without control and without clear indications; absence
of clear criteria and recommendation for antibiotic use in neonates; overuse of infusions and
blood products, mainly FFP, in the absence of indications; use of not evidence based drugs for
treatment of sick newborns (Magnesium, …); every day routine weighting, use of antiseptics
20
for eyes and umbilical stamp, as well as bathing of newborns when room temperature is low
and risk of hypothermia is high.
9. Infection prevention
The most efficient infection prevention technology – hand washing - is not
properly implemented and used in most maternities of Montenegro. In many facilities there is
a lack of properly organized places for hand washing that includes: liquid soap, disposable
towels, containers for used towel collection, antiseptic with a hopper, algorithms on hands
washing and disinfection in different manipulations. Staff is not continuously trained,
motivated and supervised on the rules and techniques of hand washing.
Many other effective infection prevention practices are also not implemented:
individual delivery rooms, skin to skin contact and early breastfeeding, appropriate antibioticprophylaxis in PROM, preterm delivery, cesarean section, rooming in and involvement of
mothers in care of sick newborns.
Instead, a big number of outdated infection control practices continue to be used: use
of two steps delivery room system (for first and second stage of labor), routine shaving and
enema. Isolation of women and newborns from their families also is incorrectly regarded as
infection prevention measure and is strictly followed in most facilities.
Recommendations for antibiotic-prophylaxis (for caesarean section, PROM, prevention of
early neonatal sepsis) and treatment are also outdated and do not correspond to international
standards. Inadequate registration of nosocomial infections, excess of invasive procedures in
neonatal department, liberal use of antibiotics both in obstetrics and neonatology, overuse of
blood products in neonatal practice are other important infection control problems to be
solved.
10. Guidelines and team work
As mentioned in the context of management of maternal complications, no national
and local protocols and algorithms (only some examples of local protocols on obstetric
emergencies in one facility) are produced and used in Montenegro. As a result, case
management varies substantially among doctors and facilities, but over-diagnosis and hypermedicalization is widespread. There are no local algorithms of management of severe
obstetrical and neonatal complications.
No national level body (group of experts, committee or something else) exist in
Montenegro to be responsible for setting standards of care in perinatology (obstetrics and
21
neonatology) and for production / adaptation / adoption and implementation of evidence
based clinical guidelines and protocols, in line with international standards and
recommendations.
Also, there is no culture of auditing of quality of perinatal care, and discussion of
cases of perinatal mortality and cases of severe maternal morbidity.
22
4. Conclusions and recommendations
The assessment showed that quality of care for mothers, newborn babies and children
was often substandard, particularly in the dimensions of information, communication,
confidentiality and holistic care of mothers and children.
The main problems that were identified were: a) the case management of most
common conditions and complications was often non complying with international standards
and evidence-based guidelines, both in obstetric/neonatal care and in paediatric care; b) the
integration and continuity of care between professionals and services (e.g. between prenatal
visits and delivery care, between subsequent admissions for the same patient, etc.) was
insufficient, so that important information for the care of patient is not readily available c)
over-medicalization of care – high rates of caesarean section, induction, stimulation,
episiotomies; d) under-use of a number of essential, WHO recommended and efficient
technologies – rooming in and promotion of early and exclusive breastfeeding; partnership
and individual delivery rooms, non-vertical positions, use of partogram for monitoring and
decision making, skin to skin contact, thermal control, preparedness for resuscitation etc. .
This situation, besides putting at risk the health of mothers and children, causes
inefficient use of resources, may cause some real emergencies not to be dealt with promptly
and appropriately.
It is important to underline that examples of good and even excellent quality of care
were also observed, showing that ensuring quality is possible notwithstanding the existent
deficiencies in health system organization, hospital infrastructure and availability of
equipment drugs and supplies.
Based on the observations and the information collected, the described situation can
be attributed to a combination of factors including: a) absence of guidelines and of diagnostic
and therapeutic protocols based on international standards; b) lack of some essential
equipment and supplies c) lack of adequate tools and systems to ensure consistency and
continuity of care within the services and across the various levels of the health systems ; d)
lack of sufficient awareness of the importance of providing adequate information to patients
and taking care of them holistically.
23
Recommendations:
1. Create a national MCH quality improvement committee/expert group consisting
from specialists in obstetrics and neonatology, midwifes and neonatal nurses,
administrators and managers, representatives of academic institutions and professional
(Ob-Gyn and Perinatology/Pediatry) associations. Members of this national body should
agree on and start implementation of effective perinatal care package based on
international EBM standards and recommendations [12, 14, 15].
2. Support development, ensure official endorsement and implementation of key set of
evidence based national clinical guidelines / protocols. The main priorities for nearest
future are protocols and standards on management of normal labour and delivery, care
of healthy new-born (including breastfeeding and warm chain), management of most
frequent and relevant obstetrical (hypertensive disorders, haemorrhages, preterm labour
and PROM, assisted vaginal delivery and shoulder dystocia) and neonatological
complications and diseases (asphyxia, sepsis, jaundice, care for low birth babies).
3. Internal organization and structure of maternities of Montenegro should be
changed to be able to offer full package of WHO recommended intra-partum and
postpartum care, including organization of individual delivery rooms, creation of
condition for partnership and rooming in etc. These changes could be done in the
framework of existing premises, without building additional ones. The only challenge to
be addressed is deficiency of space to organize sufficient number of individual delivery
rooms in maternity unit of Podgorica Clinical Center – at least 7-8 for more than 3000
deliveries.
4. Newly organized individual delivery rooms should be equipped with all necessary for
practicing effective perinatal technologies (partnership, alternative delivery positions,
ambulance and non-pharmacological methods of pain relief) and assuring safety of
labor process (equipment for resuscitation of new-born, assisted vaginal delivery, warm
chain, kits for emergency care of obstetrical complications etc.).
5. Process of reformation of quality of care for mothers and new-borns in maternities
should be started with a standard EPC training, developed by WHO Regional Office
for Europe and JSI USAID [12] (with accent also on promotion of breastfeeding [13])
for multidisciplinary teams from leading maternity units of Montenegro. It would be
rational to initiate reformation of structure, equipment and practices in maternities after
this introductory EPC course.
6. It is necessary to change actual outdated infection control practices that are not only
ineffective, but also put unnecessary barriers for practicing modern, effective perinatal
technologies.
24
7. Improve data collection, for better analysis and use for planning.
8. One of the next steps should be implementation of new EPC technologies and content of
national protocols and standards for maternity care into medical education study
curricula.
9. Issue of continuous medical (post-graduation) education of obstetricians,
neonatologists and pediatricians should be addressed. Stages of key professionals in
other countries should be recommended only in sites where evidence based practices are
implemented.
10. Organize national informational campaigns for promotion of breastfeeding; family
oriented maternity care; on risks of interventions in the normal process of pregnancy and
delivery (caesarean section, induction, augmentation, other almost routine unnecessary
procedures).
25
References
1. Pocket book of hospital care for children. Guidelines for the management of common
illnesses with limited resources. World Health Organization, Geneva, 2005
2. Campbell H, Duke T, Weber M, English M, Carai S, Tamburlini G; Global initiatives for
improving hospital care for children: state of the art and future prospects. Pediatrics 2008;
121(4):e984-92
3. Duke T, Keshishiyan E, Kuttumuratova A, Ostergren M, Ryumina I, Stasii E, Weber MW,
Tamburlini G. Quality of hospital care for children in Kazakhstan, Republic of Moldova,
and Russia: systematic observational assessment. Lancet. 2006;367(9514):919-25.
4. IMPAC Managing Complications in Pregnancy and Childbirth: A guide for midwives and
doctors 2003 WHO/RHR/00.7 http://www.who.int/reproductive-health/impac/index.html
5. IMPAC Managing newborn problems: a guide for doctors, nurses, and midwives 2003
ISBN 92 4 154622 0 http://www.who.int/reproductive-health/publications/mnp/index.html
6. IMPAC WHO Recommended Interventions for Improving Maternal and Newborn Health
2005WHO/MPS/07.05
http://www.who.int/making_pregnancy_safer/documents/who_mps_0705/en/
7. IMPAC Pregnancy, childbirth, postpartum and newborn care: a guide for essential
practice. 2006 ISBN 92 4 159084 X
http://www.who.int/making_pregnancy_safer/documents/924159084x/en/
8. WHO Regional Office for Europe Effective Perinatal Care training package
http://www.euro.who.int/pregnancy/esscare/20080122_1
9. The world health report 2000 - health
http://www.who.int/whr/2000/en/index.html
systems:
improving
performance
10. WHO European Ministerial Conference on Health Systems: “Health Systems, Health and
Wealth”,
Tallinn,
Estonia,
25–27
June
2008.
Report
http://www.euro.who.int/InformationSources/Publications/Catalogue/20090122_1
11. WHO European Strategic Approach for making pregnancy safer: Improving maternal and
perinatal health. http://www.euro.who.int/__data/assets/pdf_file/0012/98796/E90771.pdf
12. Effective perinatal care training package (EPC): http://www.euro.who.int/en/what-wedo/health-topics/Life-stages/maternal-and-newborn-health/policy-and-tools/effectiveperinatal-care-training-package-epc
13. Breastfeeding counseling: a training course:
http://www.who.int/maternal_child_adolescent/documents/who_cdr_93_3/en/
26
14. WHO Recommended Interventions for Improving Maternal and Newborn Health.
Geneva, Switzerland. World Health Organization. 2009.
http://whqlibdoc.who.int/hq/2007/who_mps_07.05_eng.pdf
15. The Packages of Interventions for Family Planning, Safe Abortion Care, Maternal,
Newborn and Child Health. Geneva, Switzerland. World Health Organization. 2010.
http://whqlibdoc.who.int/hq/2010/WHO_FCH_10.06_eng.pdf
16. Protection, promotion and support of breastfeeding in Europe: a blueprint for action.
http://ec.europa.eu/health/ph_projects/2002/promotion/fp_promotion_2002_frep_18_en.p
df
27
Annex 1.
Assessment of the safety and quality of hospital care for mothers and newborn babies in
Montenegro
Schedule of visits to maternity wards
5 – 1 4 December 2012
DATE
Wed, 05-12-12
TIME
09:30
PLACE
Meeting with national experts and initial introduction into
WHO assessment tool and methodology (Podgorica National clinic)
Cetinje General Hospital
Thu, 06-12-12
8:00 departure
Kotor General Hospital
Fri, 07-12-12
8:00 departure
Berane General Hospital
Introduction into EBM and WHO Europe strategy for
improving quality of perinatal care for group of national
assessors
Overview of effective, WHO recommended intra-partum
technologies and care for healthy newborn
Mon, 10-12-12
9:00
Podgorica Clinical Centre
Tue, 11-12-12
9:00
Meeting with the Deputy Minister of Health
Wed, 12-12-12
8:00 departure
Niksic General Hospital
Thu, 13-12-12
8:00 departure
Podgorica Clinical Centre – Pediatric Unit
Fri, 14-12-12
Presentation of preliminary results of assessment to all
interested and involved stakeholders and partners
Debriefing meeting with Benjamin Perks, UNICEF
Representative
28
Annex 2
National team of assessors:
Dr Snezana Sekulic, Gynaecologist
Dr Azis Haliti, Gyneacologist
Dr Mirjana Markovic, Neonatologist
Dr Saveta Stanisic, Neonatologist
Dr Ljubinka Dragas, Neonatologist
29
Annex 3
Table 2. Some inappropriate observed practices during of assessment of quality of
maternal and neonatal care
PRACTICES OBSERVED
Inappropriate use of drugs and use of not effective drugs

Use of diuretics and diazepam and two or more antihypertensive drugs in the
same patient in cases of pre-eclampsia

Use of estrogens to stop lactation

Use of antibiotics for 4-5 days after surgery instead of antibiotic prophylaxis in
cases of CS

Use of sedatives and anti spastic drugs during labour

Antibiotics for sepsis prevention and treatment

Use of blood products, specially frozen plasma for the treatment of sepsis and
LBW

Use of anticonvulsants in new-borns

Tocolisis at gestational age of 35-36 weeks
Inappropriate use of interventions and technology

Use of the Kristeller’s procedure1 in second stage (in case of fetal distress or
prolonged second stage)

Routine directed pushing during second stage of labour

Overuse of labour induction and augmentation

Use of CTG with no tocometry not functioning or not calibrated

Routine use of inappropriate intrapartum technologies – enema, shaving

Liberal use of episiotomy with no indication during normal labour

Inductions of labour before 42 and even 41 completed week without medical
indication
KRISTELLER’S PROCEDURE pushing out the fetus the manual assistance is at the risk of intrauterine fetal
anoxia and other complications.
Waszyński E Kristeller's procedure--Expressio fetus, its genesis and contemporary application Ginekol Pol.
2008 Apr;79(4):297-300.
1
30

Active management of labour” without use of partogram, strict criteria of labor
progress and FHR monitoring and lack of assisted vaginal delivery

Use of general anaesthesia in cases of planned CS; under-use of regional
anaesthesia

Routine immediate suction of the newborn baby

Immediate cord clamping and cutting

Use of phototherapy lamp in cases of neonatal jaundice without the guidance of
bilirubin test levels

Babies left with wet blanket for a long period

Swaddling of new-borns

Immediate weighing after birth

Oxygen use not mixed with air (in some hospitals) and no limits for hyperhypoxemia
No use or inappropriate use of effective evidence based technologies

Position during second stage of labour

Individual delivery rooms

Partnership in labor

Ambulance and free positions in first stage

Monitoring of labor progress and monitoring of fetal well-being with partogram

Not adequate FHR monitoring during second stage of labour

Obstetrical vacuum extractor absent or not used in cases of obstructed labour or
fetal distress

Active management of third stage

No skin to skin contact

Separation of babies from mother without indications

Thermal control-interruption of warm chain

No rooming in

No or poor promotion of early and exclusive breastfeeding
31
Infection’s control

Lack of fully equipped places for hand-washing

Too frequent, without indications vaginal examination without any hand washing
(just putting gloves).

Antibiotic-prophylaxis not according international recommendations

Outdated technologies persist (enema, shaving, wearing masks and gowns, no
individual delivery rooms, visitors and partners regarded as sources of infection)

Babies kept in nursery and bottle feed; use of pacifiers.

Cleanliness: surface where babies placed (radiant, incubator, exam table, bottle
for O-therapy), no washing of masks and equipment for resuscitation equipment
before each delivery, vacuum extraction equipment kept in solutions.
Preparedness for emergencies

Delivery rooms not equipped with special kits with drugs for emergencies

No measurement of blood loss

No local protocols / algorithms on treatment of obstetrical emergencies, including
PPH, eclampsia, shoulder dystocia and fetal distress.

Assisted vaginal delivery used only in some facilities

Anesthesiologists and obstetricians not available during night time in some
facilities
32
Annex 4
Reported rate (incidence) of some obstetrical interventions in 8 largest
(>300 deliveries/year) maternity units of Montenegro (2011)
N1
N2
N3
N4
N5
N6
N7
N8
Caesarean section deliveries as % of
all births
21%
27%
20%
24%
22%
29%
28%
23%
Episiotomies as % of all births
37%
80%
33%
50%
40%
53%
16%
Instrumental deliveries as % of all
births (vacuum)
2,2% -
0.2%
-
-
2%
-
0.65
%
Forceps
0.2% -
-
-
-
-
2.6% -
Inductions as % of all births
18%
20%
10%
50 ?
28%
-
8.3% 6%
Augmentations (stimulations) as %
of all births
36%
40%
60%
50 ?
60%
70.4
%
No
data
(3035)
22%
33
43%
Annex 5
REZULTATI ANALIZE KVALITETA BOLNIČKE NJEGE U PORODILIŠTIMA
Snežana Sekulić
Azis Haliti
Stelian Hodorogea
POZITIVNE OCJENE
 Infrastruktura ( struja, voda, pojednina renovirana porodilišta )
 Lijekovi , oprema
 Laboratorija ( IBD, KCCG, ....ostali u skladu sa mogućnostima )
 Dostupnost, pristup bolničkoj njezi ( transport, upućivanje na viši nivo, ne postoje
ekonomske prepreke )
 Baby friendly ( iako nije potpun)
 Neke ustanove imaju mogućnost za uspješno rješavanje hitnih slučajeva ( SC,
transfuzija, rješavanje komplikacija )
 Dobra obučenost osoblja
Stvari koje treba poboljšati
Statistika - prikupljanje, analiza i korišćenje
( br transportovanjih beba, br stimulacija, indukcija, SC, ....postoji diskrepanca između
prijavljenih i stvarnih podataka )
Odvajanje djeteta od majke nakon porođaja)
MEHANIZAM NORMALNOG POROĐAJA :
Tehnika :
- skin to skin kontakt
- prisustvo partnera
- rutinska klizma i brijanje
- slobodno kretanje i položaj
- rutinske epiziotomije
Monitoring :
- Fetalni i monitoring normalnog porođaja – partogram.
-
Visok procenat stimulacija.
Odluke za SC
Organizacija hitnog SC.
- Instrumentalni završetak porođaja (VE)
- Nema jasnih stavova o vremenskim intervalima slušanja tonova i upotrebe kontinuiranog
CTG.
Odsustvo nacionalnih smjernica i protokola kao i lokalnih protokola i algoritama za rješavanje
hitnih stanja ( preeklampsija, eklampsija, ramena distocija, PPK... )
Tretman prijevremenog porođaja, hipertenzije ( kriterijumi za tokolizu.... velike razlike u
tretmanu )
Nedovoljna kontinuirana medicinska edukacija, kratkoročna usavršavanja ( ekonomske
prepreke )
34
Annex 6
REZULTATI ANALIZE KVALITETA BOLNIČKE NJEGE U NOVORODENCE
Dr Mirjana Markovic,
Dr Saveta Stanisic,
Dr Ljubinka Dragas
Dr Audrius Maciuleavicius
Zdravo novorođenče
POZITIVNE OCJENE
- profilaksa vit. K
- imunizacija novorođenčadi
- neonatalni skrining na hipotirozu
- rani otpust novorođenčadi
- prisustvo pedijatra na porođaju
- znanje i obučenost pedijatra
Zdravo novorođenče
Unapređenje
- smernice za reanimaciju i Apgar Score
- dostupan 24 h boravak majki i novorođenčadi
- rani podoj
- edukacija majki
- prevencija hipotermije
- merenje °t novorođenčeta
(30min i 2h)
- kontrola infekcije
Bolesno novorođenče
POZITIVNE OCJENE
- adekvatan prostor za bolesno novorođenče
- oprema (inkubatori, Foto lampe, infuzori...)
- adekvatan transport
- timski rad
Bolesno novorođenče
Unapređenje
- majka i nega bolesnog novorođenčeta (promocija majčinog mleka)
- izrada nacionalnih protokola
- evidencija intrahospitalnih infekcija
- kontrola oksigenoth-prevencija ROP-a
- medicinska dokumentacija
- statistička obrada i analiza podataka
35
Annex 7
Facilities infrastructure
(in 9 maternities with >200 deliveries per year)
Sanitary conditions of maternity
Yes
No
-
Are flush toilets available in the maternity?
9
0
-
Are toilets located inside maternity
9
0
-
Toilets are located in delivery ward
7
2
-
Toilets are located in postpartum ward
9
0
-
Are toilets located outside maternity
0
9
-
Is cold water always available?
-
Is Warm water always available?
9
Is shower available for patients?
0
9
0
9
0
-
In delivery ward
6
3
-
In post-partum ward
9
0
Is/are shower(s) working
9
0
Is heating system available during winter?
9
0
Equipment and devices
Not available
Adequate lighting
-
Refrigerator
-
Refrigerator thermometer
2
Heat source in delivery room
1
Overhead heater
4
Incubators
-
Normal thermometer (body temperature)
-
Thermometer below 32°C
6
36
Phototherapy lamp
-
Steriliser
-
Weight measuring device for the baby
-
Cord cutting/cord clamping set
-
Oxygen in some delivery rooms
-
Suction apparatus
-
Bag and mask or T-piece
-
Ventouse
2
Laboratory testing capability
Not available
Blood glucose
-
Blood bilirubin
-
Immature to total neutrophil ratio
5
Haemoglobin test - venous sample
-
Haemoglobin test - finger prick
-
Haematocrit
-
Leukocytes count
-
Blood gazes
3
Blood group
-
Rhesus antibodies
-
Urine protein
-
Urine microscopy
-
Bacteriology (culture)
1
Bacterioscopy (smear)
1
37