Egyptian Neonatal Safety Standards

Copyright Egyptian Neonatal Safety Training Network Project

www.egyneosafe.net “This project has been funded with support from European Commission. This publication reflects the views only of the authors, and Commission cannot be held responsible for any use which may be made of the information contained therein.”

Egyptian Neonatal Safety

Training Network

(ENSTN)

Tempus grant; 543823-TEMPUS-1-

2013-1-EG-TEMPUS- JPHES

Egyptian Neonatal Safety Standards

2014

http://www.egyneosafe.net/


الوالدةالشبكة المصرية لسالمة حديثى

Egyptian Neonatal Safety Training Network

ENSTN

Grant Holder and Project Coordinating Institution AL Azhar University

Principal investigator and project contact coordinator

Dr. Safaa Abd ELHamid ELMeneza. Professor of Pediatrics/Neonatology

AL Azhar University.

European Beneficiary Institutions and site contact University del Pais Vasco /Herriko Unibertsitatea: Professor Izaskun Asla

Elorriaga

University of Liverpool: Professor Michael Weindling

University of Tartu : Professor Tuuli Metsvaht

Egyptian Beneficiary Institutions and site contact Mansoura University : Professor Mohamed Reda Bassiouny

Tanta University : Professor Mohamed Rowisha

Suez canal University: Professor Mohammed ELKaliopy

Zagazig University :Professor Ehab Al-Banna

Project Experts Professor Nadia Badrawy Professor of Pediatrics: Cairo University and

president of EAN , Arab network of QA in higher education

Professor Suzan Farhoud Regional Advisor for Child and Adolescent Health

Eastern Mediterranean Regional Office of WHO/EMRO

http://www.bassiouny.name.eg/


Introduction

This document was a dream for all neonatologists and health care

workers, who are participating in care of the newborn infants .We thanks all our beneficiaries and stakeholders who participated and

supported us during the preparations of the standards whether during

the foundation workshop on 17-18 May 2014 or through video conference and email. It was really great work and enormous efforts

starting from the situation analysis of NICUs and surveys in order to

estimate the real situations regarding current knowledge, skills and attitude towards safety of care in NICU. The standards were prepared

from different sources; national and international, so the input will at

same levels worldwide and allows continuous improvement according to the new experiences. We are proud by this output and have the

pleasure to introduce to all colleagues in Egypt and worldwide.

Project technical co contact -coordinator

Dr.Sanaa Tantawy. Alzhraa University hospital

Project co- contact coordinator and co-PI

Dr. Mariam Abu Shady .Professor of Pediatrics/Neonatology ALAzhar

University.

Principal investigator and project contact coordinator

Dr. Safaa Abd ELHamid ELMeneza. Professor of Pediatrics/Neonatology AL

Azhar University.



Document is Prepared and Edited

by

Dr. Safaa Abd EL Hamid ELMeneza, MD,DTQM,DGSHH

,DHPE

Professor of Pediatrics /Neonatology

ALAzhar University, Cairo ,Egypt

Reviewed by

Dr. Michael Weindling, Professor Pediatrics /Neonatology

University of Liverpool, United Kingdom

Dr. Izaskun Asla Elorriaga, Professor of Pediatrics Neonatology

& Agueda Azpeitia García, Biostatistician, University del Pais

Vasco /Herriko Unibertsitatea, Spain

Acknowledgment

We would like to acknowledge all the beneficiaries, workshop participants and experts for advice that guide to prepare this

document.



Definition of safety safe·ty

noun, plural safe·ties.

1. The state of being safe; freedom from the occurrence or risk of injury,

danger, or loss.

2. The quality of averting or not causing injury, danger, or loss.

3. A contrivance or device to prevent injury or avert danger.

4. The action of keeping safe.

Patient safety is a discipline in the health-care sector that applies safety science

methods towards the goal of achieving a trustworthy system of health-care

delivery. Patient safety is also an attribute of health-care systems; it minimizes

the incidence and impact of, and maximizes recovery from adverse events.

Simply it is absence of preventable harm to a patient during the process of

health care.

Definition of standard

An average or normal requirement, quality, quantity, level, grade

standard, criterion refers to the basis for making a judgment.

A standard is an authoritative principle or rule that usually implies a model or

pattern for guidance, by comparison with which the quantity, excellence,

correctness.

Introduction

Safety is a fundamental principle of patient care and a critical component of

quality management. Its improvement demands a complex system-wide effort.

Patients in the NICU are very small and fragile, many with immature organ

systems, and superimposed serious illness. Such infants are likely to receive

complex care, including a large number of medications, and/or invasive

procedures for diagnosis and treatment over an extended hospitalization.

A single patient typically receives care from a team of experts. These increase

the potential for errors and add additional demands for a higher threshold for

device safety and efficacy, exemplifying the need for error-free devices and

instruments.


Given the narrow margin of safety, the patients are also more likely to suffer

from harmful consequences of errors sooner. Because of their unique

vulnerability, even minor errors can lead to devastating short and long-term

consequences. In large general hospitals, patient safety efforts are likely to be

targeted toward adult patients or treatment units, with little appreciation for the

unique needs of the NICUs and their patients.

Provision of high quality care for neonates and their families .The purpose is to

support delivery of high quality evidenced-based, safe, effective and

person-centered neonatal care. Healthcare quality strategy is presented under the

six dimensions of quality: • Person-centered

• Safe

• Effective

• Efficient

• Equitable

• Timely

These standards are dealing with all locations, process that newborn infants and

families may seek medical care .It is important to locate where and why adverse

events occur. Starting from delivery room, outpatient clinics, private or general

hospitals NICUs, events may happen.

Adverse events may therefore result from problems in practice, products,

procedures or systems. Most adverse events are not the result of negligence or

lack of training, but rather occur because of latent causes within systems.

Enhancing the safety of patients includes three complementary actions:

preventing adverse events; making them visible; and mitigating their effects

when they occur. In general, national programs have to be built around these

principles.

The aim for the standards proposed by Egyptian Neonatal Safety Training

Network is to embrace nearly all health care disciplines and actors, in NICU and

endorse a comprehensive multifaceted approach to prevent and manage the

actual and potential risks to patient safety in NICU and to offers national

standards to be adopted by MOH, Universities and other health care facilities.

Also Reporting and Learning System database will be implemented to allow

continuous learning from errors and disseminate patient safety culture in Egypt.


The Standards

(I)General standards

Standard (1): Provide high quality service care

Rationale

Public assurances regarding the quality and safety of care of newborn

infants have to be supported through a robust governance structure which

is focused on the safety of patients.

Requirements:

-Ensuring all health care staff (physician, nurses, and allied health

professional) with the appropriate skills is available; treating babies in

units.

-Facilities are appropriate to the needs; undertaking regular audit of

practice. 1. Appropriate NICU design

2. Appropriate NICU NICU Location Within the Hospital

3. Adequate Family Entry and Reception Area 4. Provide Airborne Infection Isolation Room(s)

5. When appropriate Operating Rooms Intended for Use by Newborn ICU

Patients 6. Adequate Electrical, Gas Supply, and Mechanical Needs

7. Adequate Ambient Temperature and Ventilation

8. Adequate Handwashing 9. Adequate General Support Space -Staff Support Space-Support Space for

Ancillary Services-Administrative Space-Family Support Space

10. Appropriate Ceiling Finishes -Wall Surfaces - Floor Surfaces

11. Adequate Furnishings 12. Appropriate Ambient, Lighting in Infant Care Areas- Procedure Lighting in

Infant Care Areas - Illumination of Support Areas – Daylighting

13. Acoustic Environment

-Ensuring staff have appropriate training.

-Ensuring regular audit and checklist are developed. Applies to: Ambulatory Care, all levels of NICU, Disease-Specific Care, Laboratory Services,

Long Term Care, Surgery, Delivery room

Standards (2): Person-centered care for newborn infants

Rationale

High-quality service focuses on the needs of the baby and family by

responding to the families’ cultural and religious preferences. Needs and

values are mandatory for quality of care.


Requirements:

- Define and communicate the means for parents to report concerns about

safety and encourage them to do so.

-Parents education regarding safety issues in NICU.

-Encourage parents in the’ active involvement in their own baby's care as

a patient safety strategy. Applies to: Ambulatory Care, all levels of NICU, Disease-Specific Care, Laboratory Services,

Long Term Care, Surgery, Delivery room.

Standard 3: Timely Care

Rationale

Neonates will be cared for in the right place, at the right time and by the

right people with the right skills.

Requirements:

- Timely provision of clinical care with no unnecessary delays.

- Minimal delays in emergency transfer and access to care.

- Effective deployment of teams for planned transfers.

- Sustainable transport infrastructure to support the service and effective

and timely communication with obstetric staff.

- Communication between different areas in transfers.

- Protocols in emergency units and NICU. This will be evidenced by: • The benefits of breastfeeding being highlighted at the earliest possible opportunity following delivery.

• The provision of clinical care and therapeutic interventions in line with current

guidelines and timescales as specified by professional bodies, based on substantiated

evidence. • The adherence to standards and guidelines pertaining to national immunization,

national screening, neuro-developmental assessment and follow-up programs.

• A named consultant making contact with the parents at an appropriate time to offer discussion and counselling following the death of a baby. This will take place no later

than seven weeks following bereavement.

• Transitional care being recognised as part of the full spectrum of neonatal care and being made available to parents, including those progressing from special care.

Applies to: Ambulatory Care, all levels of NICU, Disease-Specific Care, Laboratory Services,


Standard 4: Improve the accuracy of newborn infants identification

and prevent identification errors

Rationale

-Wrong –identification of newborn infants may cause lifelong pain to

families and infants/children and lead to mixing of lineages.

-Wrong-patient errors occur in virtually all aspects of diagnosis &

treatment. The intent for this standard is two-fold:


First: to reliably identify the baby as the person for whom the service or

treatment is intended.

Second: to match the service or treatment to that baby.

Requirements:

-Newborn infants (healthy or sick) must have immediately name tag with

mother's name, date of and time of birth, given name if available, around

the wrist of the hand and ankle.

-Newborn infants (healthy or sick) must be photographed immediately

after birth with at least 2 pictures with name will be written on the

pictures. One picture will be given to mother while second picture must

be kept in the record.

-Newborn infants (healthy or sick) their finger prints must be taken

immediately.

-Whenever it is possible DNA identification by an umbilical cord blood

sample.

-Use at least two patient identifiers whenever providing care, treatment or

service as collecting laboratory samples or administrating medications or

blood products as bay’s name ,mother’s name or incubator /bed number .

-Acceptable identifiers may be the individual’s name, an assigned

parent's identification number, telephone number, photograph or other

person-specific identifier, (e.g. birth date).

- Prior to the start of any invasive procedure, conduct a final verification

process, (such as a “time out,”) to confirm the correct patient, procedure

and site using active—not passive—communication techniques. Applies to: Ambulatory Care, all levels of NICU, Disease-Specific Care, Laboratory Services,


Standard 5: Improve the effectiveness of staff communications among

NICU caregivers

Rationale

-Ineffective communication is the most frequent cited category of root

causes of sentinel events.

-Effective communication, which is timely, accurate, complete,

unambiguous, and understood by the recipient, reduces error and results

in improved patient/client/resident safety.

Requirements:

-Improve communication for verbal or telephone orders or for telephonic

reporting of critical test results.

-Simply repeating back the order or test result is not sufficient; verify the

complete order or test result by:


-The receiver of the order should write down the complete order or test

result or enter it into a computer, then read it back, and receive.

confirmation from the individual who gave the order or test result.

- A standardized approach to hand over communications, including an

opportunity to ask and respond to questions.

- Telephone orders must reserve, only in extreme cases.

-“Critical test results” for newborn infants are defined and include “stat”

tests, reports, and other diagnostic test results that are done routinely and

those where the results require urgent response.

-Standardize a list of abbreviations, acronyms, symbols, and dose

designations that are not to be used throughout the organization.

- Example: Abbreviations not to be used throughout the organization are: 1. U

2. IU

3. Q.D., QD, q. d. qd

4. Q.O.D., QOD, q. o. d. qod

5. MS

6. MSO4

7. MgSO4

8. Trailing zero

9. No leading zero



Standard 6: Use medicines safely in NICU

Rational

-Unsafe use of medications may endanger life of newborn infants and

cause sentinel events.

-It has been reported that about 55% of prescriptions in NICUs use drugs

‘‘off label’’ and that 10% use unlicensed drugs. Also there is potential

tenfold drug overdoses exacerbated by the high strength of intravenous

vials, manufactured to provide adult size doses. NB: Some medications are not used for newborn infants; also newborn infants need specific

small doses from the permitted drugs to prevent over dosages.

Requirements:

-To achieve needs of the neonatal population specific lower drug

concentrations are only allowed to be used.

-Make list and don’t use drugs that are contraindicated for newborn

infants.

-Use specific vials with single use.

-Remove concentrated electrolytes (including, but not limited to,

potassium chloride, potassium phosphate, Na cl > 0.9%) from patient care

units.


-Standardize & limit the number of drug concentrations available in the

organization.

- Concentrated medications not removed are segregated from other

medications with additional warnings to remind staff to dilute before use.

-Label all medications, medication containers (e.g., syringes, medicine

cups, basins), or other solutions on and off the sterile field in peri-

operative and other procedural settings.

-A process / checklist have to be developed to verify that all documents

and equipment needed for resuscitation , invasive procedures or surgery

are on hand, correct and functioning properly before beginning.

-Reference book as Neofax or similar must be available to review doses.

- Whenever using vials/medications that are going to be for multiple or

repeated use, the opening date should be written on the vials.

- Supply all units with wall chart or poster for proper dissolving materials

for various drugs, and doses of critical medications as well as route of

administrations.

In addition to the regular hospital requirements:

-Identify and, at a minimum, annually review a list of look-alike/sound-

alike drugs used by the organization, and take action to prevent errors

involving the interchange of these drugs.

- Reduce the likelihood of patient harm associated with the use of

anticoagulation therapy.

-Procedures are made to inhibit the use of drugs ‘‘off label’ and

unlicensed drug in NICU.

-Use and encourage manufacture of neonatal size vials Applies to: Ambulatory Care, all levels of NICU, Disease-Specific Care, Laboratory Services,


Standard 7: Elimination of wrong site, wrong patient and wrong

procedures and surgery

Rationale

Wrong-site, wrong-patient, wrong-procedure surgery can be prevented if

appropriate processes are in place. The intent is to establish and

implement processes to always identify the correct body site, correct

person and correct procedure.

Requirements:

-The requirement is for a “preoperative verification process” before

starting. The checklist is an example of one approach – the most common

one. The intent of the requirement is to ensure that all of the relevant

documents are available prior to the start of the procedure & that they


have been reviewed & consistent with each other & with staffs’ under-

standing of the intended site, patient, & procedure.

-The precise site where the surgery or invasive procedure will be

performed is clearly marked with the involvement of the patient.

-There is a documented process to verify an accurate accounting of

sponges, needles and instruments pre and post procedure.

Standard 8: Reduced risk of health care acquired infections in NICU

Rationale

-Compliance with the CDC hand hygiene guidelines/WHO will reduce

the transmission of infectious agents by staff to newborn infants.

-HCAI is not miss fortune it is error of care; if fatal it has to be

considered as sentinel event.

Requirement:

-Comply with current World Health Organization (WHO) & the Centers

for Disease Control and Prevention Hand Hygiene Guidelines.

-Use proven guidelines to prevent infections that are difficult to treat.

-Use proven guidelines to prevent infection of the blood from central

lines.

-Use proven guidelines to prevent infection after surgery.

-Use proven guidelines to prevent infections of the urinary tract that are

caused by catheters.

-Comply with Dress code.

-Manage as sentinel events all identified cases of unanticipated death or

major permanent loss of function associated with a health care-associated

infection.

-Judicious use of antibiotics.

- Gloves, gowns, masks, soap, disinfectants and washing detergents are

available and used correctly when required.

-Hand washing and disinfecting procedures are used correctly.

-Approved policies and procedures are disseminated in nursery, level I,

II, III, IV NICU.

-Policy and procedure describes infection control practices and include at

least the following: 1. Selection and uses of antiseptics and disinfectants. 2. Hand washing techniques.

3. All cleaning activities.

4. Types of isolation with standard precautions (contact and airborne).

5. Hemorrhagic patients. 6. Disposal of sharps and hazardous materials.

7. Identification and management of organization-acquired infections.

8. Infection control surveillance and data collection.


9. Reporting of patients with suspected communicable diseases as required by

law and regulation. 10. Management of outbreaks of infections.

- A qualified physician and a qualified nurse jointly oversee the infection

control activities.

-There is a continuous program to reduce the risks of organization

acquired infections in NICU.

-The infection control program includes patients, staff, and visitors.

-Approval of all relevant infection control policies, procedures and

surveillance activities.

-Identify those procedures and processes associated with increased risk of

infection.

-Sterilization of all equipment according to guidelines of CDC and

manufacture. The organization has a central sterilization supply department or defined area.

-The functions of cleaning, processing, and sterile storage and distribution are

physically separated.

-In all areas where instruments are cleaned there must be airflow that prevents.

cross-contamination and prevents contaminated material from exiting the area. -There is documented evidence that complete sterilization has been accomplished.

-Policy and procedure guides each sterilization technique or device used, and

includes the manufacturer's recommendations. -Policy and procedure describes the processes including at least the following;

1. Receiving and cleaning of used items and disinfection.

2. Preparation and processing of sterile packs. 3. Storage of sterile supplies.

4. Inventory levels.

5. Emergency flash sterilization.

6. Expiration dates for sterilized items.

-Laundry and Linen

Policy and procedure defines laundry and linen services and includes at

least the following:

-Collection and storage of contaminated linen.

-Cleaning of contaminated linen. -Storage and distribution of clean linen.

-Quality control program, including water temperatures.

-Contaminated linen is separated from clean linen.

-Surveillance and Monitoring -The Infection Control surveillance program for NICU has to be implemented. -Results of the surveillance program are reported at a minimum quarterly to the

infection control committee and to the leadership.

-Results of the surveillance are compared with internal and external benchmarks.




Standard 9: Reduce risk of newborn harm resulting from accidental fall

during care

Rationale

-Newborn infants are subjecting to fall if inappropriately placed on

resuscitation tables, incubators or slipped during given bath.

-Falls account for a significant portion of injuries in hospitalized patients.

-The organization should assess its patients risk for falls and take action

to reduce the risk of falling and to reduce the risk of injury, if a fall

occurs.

Requirements:

-As appropriate to the newborn infants, the services provided, and the

environment of care, a fall reduction program may include risk.

assessment and periodic reassessment of the newborn infants or of the

environment of care.

-Implement a fall reduction program including an evaluation of the

effectiveness of the program.

-The program should include risk reduction strategies, in – services,

involving patients/families in education and environment of care

redesign. The program should also include development and

implementation of transfer protocols when relevant.

-Action is taken to decrease or eliminate any identified risks for falling. Applies to: Ambulatory Care, all levels of NICU, Disease-Specific Care, Laboratory Services,


Standard 10: Improve the safety of using infusion pump

Rationale

An error in the use of infusion pumps could lead to severe damage in the

newborn.

Requirements:

-Appropriated trained staff that is capable to insert and monitor fluid and

medication therapy.

-Adequate schedule for maintenance of safety of infusion pump with

check list showing details of maintenance. Applies to: Ambulatory Care, all levels of NICU, Critical Access Hospitals, Disease-Specific

Care, Home Care, Hospitals, Laboratory Services, Long Term Care, Surgery, Delivery room.

Standard 11: Use monitor alarms safely for patient stability

Rationale

Optimum alarms can give an early warning that a patient is unwell and

alert care givers so that timely intervention can be introduced.


Requirements:

-Preventive maintenance and testing of critical alarm systems is

implemented and documented.

-Alarms are activated with appropriate settings and are sufficiently

audible with respect to distances and competing noise within the unit.

-Make improvements to ensure that alarms on medical equipment are

heard and responded to on time.

- Alarm limits should be adequately set to the patient necessities.

Standard 12: Accurately and completely reconcile medical care and

medications across the continuum of care of the newborn infants

Rationale

Accurately and completely reconcile medical care and medications across

the continuum of care are mandatory. Complete data from the facilities

where babies were born, or during transfer to and from other departments

of hospitals.

Requirement:

-A process for comparing the infant's, medical current care and

medications with those ordered for the baby while under the care of the

organization.

-A complete list of the infant's, medications is communicated to the next

provider of service when infant's, is referred or transferred to another

setting, or level of care within or outside the organization.

-The complete list of medications is also provided to the parents on

discharge from the facility.

- A process is implemented to obtain and document a complete list of the

infant's, current care and medications upon admission to the organization

and with the involvement of the infant's, parent.

-A complete list of the infant's, medications to be taken after discharge is

provided to the patient.

-The discharge medication list is communicated to the next provider of

service when the infant's, is referred or transferred outside the

organization. Applies to: Ambulatory Care, all levels of NICU, Critical Access Hospitals, Disease-Specific


Standard13: Ensure safety timely immunization.

Reduce the risk of respiratory syncytial virus

Rational

-Newborn infants and preterm are liable for viral, bacterial and fungal

infection.


-There is concern about potential adverse events following immunization.

Requirement:

-Develop and implement a protocol for administration and documentation

of the vaccines and immunoglobulins.

-Develop and implement a protocol to identify new cases of infection as

respiratory syncytial virus and manage an outbreak.

Standards 14: Reduce the risk of fires in NICU

Rationale

-NICU hosts equipment, medications, alcohol, oxygen and other

sterilization materials that may cause fire.

-Also excessive heat and improper use of instruments as phototherapy

might cause fire.

Requirement:

-Educate NICU staff, house officers and other health care providers on

how to control heat sources, manage fuels.

-Implementation of neonatal patient’s safety standards and associated s

components in practice.

-Fire and smoke safety plan that addresses prevention, early detection,

response, and safe exit when required by fire or other emergencies.

-The Fire Safety plan addresses the objectives, scope, performance, and

effectiveness.

-Evacuation plan. Applies to: Ambulatory Care, all levels of NICU, Disease-Specific Care, Laboratory Services,


Standard 15: Identify patient safety risks/ Focused Risk Assessment

Rationale

Specific risks to NICU have to be identified.

Requirement:

-The organization identifies safety risks inherent in its patient population.

-The organization identifies patients at risk for infants kidnapping, or

abundance of newborn infants after delivery of switching neonates.

There is an Emergency preparedness plan for internal and external

emergencies that addresses the objectives, scope, performance, and

effectiveness. The organization identifies risks associated with long-term oxygen therapy such

as home fires for infants with BPD.

There is a Safety and Security plan that addresses the objectives, scope,

performance, and effectiveness.


There are measures to protect against infant/ abduction and to protect patients,

visitors, and staff from harm, including assault.

All organization staff can be identified at all times.

Individuals without identification are investigated.

Remote or isolated areas of the facility are monitored.

Action is taken to correct identified deficiencies in safety and security. Applies to: Ambulatory Care, all levels of NICU, Disease-Specific Care, Laboratory Services,


Goal 16: Improve recognition and response to changes in a patient’s

condition

Rationale

Close and prompt professional response has to be taken.

Requirement:

The organization selects a suitable method that enables NICU staff

members to directly request additional assistance from a specially trained

individual's when the patient’s condition appears to be worsening. Applies to: Ambulatory Care, all levels of NICU, Critical Access Hospitals, Disease-Specific


Standard 17: Care of newborn infants must ensure the use of the well-

functioning machines and equipment

Rationale

-Malfunctioning equipment as ventilators may cause severe adverse

events to the newborn infants.

-A high quality service will ensure babies will be treated in a facility that

promotes patient safety and is appropriate to the clinical need.

Requirements:

-Plan for inspecting, maintaining, and testing medical equipment.

-Schedule for inspection and preventive maintenance according to

manufacturer's recommendations.

-Testing of all new equipment before use and repeat testing when

required by qualified individuals.

-All medical equipment in the neonatal unit being of a safe standard and

being routinely maintained, including laboratory/near patient testing

equipment.

-Suitable equipment being available in any location where neonatal

resuscitation maybe required.

-Centers providing neonatal surgery has an emergency theatre available at

all times to provide neonatal surgery as close to the neonatal unit as

possible.


-Specialist neonatal surgery services being located in the same hospital

site as specialist Paediatric (including surgery and anesthesia), maternity

and neonatal intensive care services. Applies to: Ambulatory Care, all levels of NICU, Disease-Specific Care, Laboratory Services,


Standard 18: The Utility System has to be maintained

Rationale

Problem with power or water supply can affect the safety of medical care

in NICU.

Requirements: There is a plan for regular inspection, maintenance, and repair of essential utilities

that addresses at least the following: 1. Electricity, including stand-by generators.

2. Water.

3. Heating, ventilation, and air conditioning, including air flow in negative and positive pressure rooms, appropriate temperature, humidity, and eliminates odors.

4. Medical gases.

5. Communications. 6. Waste disposal.

7. Regular inspections.

8. Regular testing.

9. Regularly scheduled maintenance. 10. Correction of deficiencies identified.

Applies to: Ambulatory Care, all levels of NICU, Disease-Specific Care, Laboratory services,


Standard 19: Measurement of neonatal care

Rationale

A high quality neonatal service will promote an improvement-focused

culture through a commitment to patient safety and the delivery of quality

improvement and sustainable services.

Requirements:

-Participation within local, regional and national audit programmes.

-Provision of data to support and demonstrate clinical quality and service

improvement.

-Development of indicators of care. Applies to: Ambulatory Care, all levels of NICU, Disease-Specific Care, Laboratory Services,



(II)Specific standards

Standard 1: Provide patient pathways

Rationale

Patient pathways will standardize high quality safe neonatal service

across all the regions.

Requirements:

-A streamlined pathway between obstetric and neonatal care.

-Babies being managed in the appropriate level of facility, so that when

severity of illness increases or decreases, babies are cared for in the safest

environment.

-Support and advice where required, within local services and across the

network.

-Availability of specialist services, on a national and regional level.

-Availability of surgical services.

-Community care being provided following discharge if required.

-Neuro-developmental assessment and follow-up being undertaken,

where ever the newborn is discharged.

-Clinically appropriate to comply with standards.

-Care being provided in line with the recommendations of condition-

specific.

-Clear referral pathways for specific neonatal conditions not wholly

managed within the local unit, e.g. therapeutic hypothermia.

-Palliative/end-of-life care pathways.

-Units demonstrating that these pathways are in place, staffs have

knowledge of same; pathways are universally complied with and, where

local guidelines exist, they promote adherence to the agreed pathways. Applies to: Ambulatory Care, all levels of NICU, Critical Access Hospitals, Disease-Specific


Standard 2: Ensure safe transfer for newborn infants

Rationale

Inadequate medical care during transfer to health care facilities causes

mortality and severe morbidity.

Requirements:

-Guidelines for infants transfer.

-Hotline for nearby facilities.

-Education of health care providers in primary health care centers.

-Parent's education.

-Ambulance provided with functioning life support equipment.

Emergency transfer


A high quality service will provide a timely transfer for unscheduled cases.

This will be evidenced by: • Delays in all types of transfers being captured in audit data at unit level. This will

capture where there have been delays, highlight critical incidents and ascertain the

reason for delays.

• The neonatal transport service liaising will initiate improvement. programs and work with transport teams to minimise delays in the future.

Nonemergency transfers. This will be evidenced by:

• Repatriation, or back transfer, being undertaken as soon as it is clinically appropriate for the baby.

• Where a baby is being returned to a unit following a surgical procedure,

the surgical team ensuring timely communication with the unit concerning

forthcoming transfer.

Transfer Guidelines A high quality neonatal service will have guidelines in place for ex-utero transfers.

This will be evidenced by ex-utero transfer guidelines which cover:

• Referral processes. • Indications and contra indications for transfer.

• Documentation of discussions between healthcare staff and women/parents/families

undergoing transfer.

• Documentation of discussions between receiving and sending units.

•Families undergoing transfer.

-Documentation of discussions between receiving and sending units. -The written documentation of management prior to and during ex- utero

transfers.

-In-utero transfer guidelines will be in place to cover referral processes and

documentation of discussions between receiving and sending units. -A high quality service will ensure timely access to an appropriate level of care

and expertise which results in the best possible outcome for neonates and their

families. •Communication with Obstetric Staff

•This will be evidenced by:

-A structured communication process between neonatal and obstetric staff. -Regular case discussions taking place with the neonatologist, in units delivering

obstetric care to high risk women and infants.

-The use of established channels of communication to share key information

with the referring unit whilst the patient is still in the tertiary unit and after discharge, including death.

Applies to: Ambulatory Care, all levels of NICU, Critical Access Hospitals, Disease-Specific


Standards (3): Care of the newborn immediately after birth

Rationale

Availability of trained staff (nurses, physicians) to provide appropriate

resuscitation according to the need.

Requirements:

-Skilled birth attendant.

-Sterile equipment.




Standard 4: Newborn infants with low Apgar score at 5 minutes should not

go home till checked by senior neonatologist

Rationale

Some infants with perinatal asphyxia may have delayed neurological or

renal or GIT manifestations.

Requirement:

-Every newborn infant with low Apgar score at 5 minutes will be

examined before discharge home by senior neonatologist.

-Schedule for checkup. Applies to: Ambulatory Care, all levels of NICU, Critical Access Hospitals, Disease-Specific


Standard 5: Oxygen must be considered as serious drug when treating

newborn infants.

Rationale

Oxygen toxicity especially for preterm infants causes severe adverse

effects.

Requirements:

-Guidelines for accepted oxygen saturations.

-Use the lowest possible concentration according to need.

-Stop use oxygen as soon as baby's condition is improved.

-Monitor oxygen saturation whenever it is possible. Applies to: Ambulatory Care, all levels of NICU, Critical Access Hospitals, Disease-Specific


Standard 6: Ensure safe invasive maneuvers when indicated for care of

newborn infants

Rationale

Untrained medical staff may cause adverse effect and serious injuries to

newborn infants.

Requirements:

-List of all invasive procedures required for newborn infants.

-List of absolute and relative indications for invasive procedures.

-Educate NICU staff using models to acquire skills.

-Junior staff will perform procedure under supervision of the expert

neonatologist.




Standard 7: Resuscitation of newborn infants by expert staff

Rationale

Brain damage may occur due to inadequate resuscitation.

Requirements:

-Educated staff.

-Regular resuscitation workshops.

-Briefing of resuscitation in DR and NICU.

-ET intubation in DR and in NICU has to be subjected to audit. Applies to: Ambulatory Care, all levels of NICU, Critical Access Hospitals, Disease-Specific


Standard 8: Encourage noninvasive ventilation in DR and in NICU

Rationale

Lung injury starts after 3-5 positive pressure ventilation.

Requirements:

-Educated medical staff of NICU.

-Use of invasive ventilation has to be evaluated regularly to start weaning

as soon as possible. Applies to: Ambulatory Care, all levels of NICU, Critical Access Hospitals, Disease-Specific


Standard 9: Proper use of surfactant

Rationale

Prophylactic surfactant may not be needed.

Requirements:

-Guideline for indication of surfactant for preterm infants has to be

standardizing including its type, time and frequency.

-Guideline for indication of surfactant for full term infants has to be

standardizing including its type, time and frequency. Applies to: Ambulatory Care, all levels of NICU, Critical Access Hospitals, Disease-Specific


Standards 10: Judicious use of medications that have effect on quality of

life.

Rationale

-Drugs as corticosteroids may affect brain development.


-Use of ototoxic drugs e.g. aminoglycosides, requirements: these drugs

affect hearing. Requirements:

-List of drugs that may affect the brain development.

-List of drugs that may affect normal development of newborn infants.

-List of possible alternative drugs.

-Indication for use of steroid including dose, route, duration and

preparations. Applies to: Ambulatory Care, all levels of NICU, Critical Access Hospitals, Disease-Specific


Standards 11: All newborn infants who have been admitted to NICU must

subject to fundus examination, hearing evaluation and skull ultrasound

before discharge.

Rationale

-Newborn infants in the NICU are exposed to high concentration of

oxygen for variable duration, as well as drugs and inadequate nutrition;

these have adverse effects on the retina and brain.

-Case of neonatal jaundice as high levels of bilirubin may cause auditory

neuropathy in which there is absent ABR & normal OAEs.

Requirements:

-All infants must have at least one fundus examination, hearing test

(auditory brainstem response {ABR} and otoacoustic emissions {OAEs})

and skull US.

-Follow up visits has to be scheduled with parents according to the

individual case. Applies to: Ambulatory Care, all levels of NICU, Critical Access Hospitals, Disease-Specific

care, Home Care, Hospitals, Laboratory Services, Long Term Care, Surgery, Delivery room.

Standard 12: Initiation of breastfeeding

Rationale

All newborn infants, including low-birth-weight babies who are able to

breastfeed, should be put to the breast as soon as possible after birth when

they are clinically stable, and the mother and baby are ready. Exclusive

breastfeeding may be encouraged if possible.

Requirements:

-Maternal education.

-Health care provider's education.

-Rooming in.

-lactation consultation.




Standard 13: Scheduling the optimum timing of discharge from NICU or

nursery or other health care facilities.

Rationale

Timing of discharge has to be planned according to health care need of

the newborn infants.

Requirements:

-After an uncomplicated vaginal birth in a health facility, healthy mothers

and newborns should receive care in the facility for at least 24 hours after

birth.

-Complicated deliveries infants should not be discharged until they have

stable general condition, adequate feeding, and breathing and maintain

normal body temperature. Applies to: Ambulatory Care, all levels of NICU, Critical Access Hospitals, Disease-Specific

care, Home Care, Hospitals, Laboratory Services, Long Term Care, Surgery, Delivery room.

Standard 14: Prevent total parenteral nutrition errors

Rationale

TPN is needed for sick newborn infants who cannot tolerate enteral

feeding as well as for ELBW. Inadequate preparation, dosages,

concentrations and mixing may cause harm to newborn infants. Moreover

complications from arterial and venous catheters are not uncommon.

Requirements:

-Improve capacity and skills of the staff for applications of catheters.

-Guidelines for TPN indication, preparations.

-Improve capacity of nursing staff for safe use of catheters. Applies to: Ambulatory Care, all levels of NICU, Critical Access Hospitals, Disease-Specific


Standard 15: Improve the accurateness of respiratory care, resuscitation-

related, and ventilator care-related errors

Rationale

Majority of admitted newborn infants are subjected to respiratory care

and resuscitation care as well as ventilator care with chance or increasing

errors especially during night shift and weekends. These errors can be

minimized by training and improving working environment.

Requirements:


-Continuous training of health care workers on resuscitations skills,

respiratory care and ventilators manipulation.

-Reporting errors, team discussion and corrective actions.

-involvement of staff nurses is mandatory.

-Involvement of technician. Applies to: All levels of NICU, Critical Access Hospitals, Disease-Specific Care, Home Care,

Hospitals, Laboratory Services, Long Term Care, Surgery, Delivery room.

Standard 16: Prevent diagnostic errors among neonatal population

Rationale

Late /wrong diagnosis may augment the increase morbidity and mortality.

Requirements:

-Guidelines, policies and clinical paths that relates signs and symptoms to

diagnosis.

-Effective communication between staff neonatologist, laboratory

specialist, and radiologist.

-Effective leadership.

-Continuous training.

-Evidence based Medicine. Applies to: Ambulatory Care, all levels of NICU, Critical Access Hospitals, Disease-Specific



References: 1- Hospital National Patient Safety Goals, The joint commission accreditation

Hospital, May2014. www.jointcommission.org.

2- Luxembourg Declaration on Patient Safety.

http://ec.europa.eu/health/ph_overview/Documents/ev_20050405_rd01_en.pdf

Luxembourg, 5 April 2005.

3-Ministry of health of Egypt, quality guidelines. General directorate of quality

2007.

4-Neonatal Care in Scotland: A Quality Framework, Neonatal Expert Advisory

Group, February 2013:www.scotland.gov.UK.

5- Patient Safety, Infection Control and Environmental Safety from Ministry of

health of Egypt, (PS, IC, ES) 2007.

سالمة المريض و مكافحة العدوى والسالمة البيئية

6- Tonse N. K. Raju, Gautham Suresh, and Rosemary D. Higgins .Patient Safety

in the Context of Neonatal Intensive Care: Research and Educational

Opportunities. Eunice Kennedy Shriver National Institute of Child Health and

Human Development, Bethesda, MD, 20952; Dartmouth-Hitchcock Medical

Center Lebanon, NH 03756.Pediatr Res. 2011 July ; 70(1): 109–115.

doi:10.1038/pr.2011.334.

7-WHO recommendations on postnatal care of the mother and newborn, 2013.

http://apps.who.int/iris/bitstream/10665/97603/1/9789241506649_eng.pdf.

http://www.scotland.gov.uk/

http://apps.who.int/iris/bitstream/10665/97603/1/9789241506649_eng.pdf


List of participants According To Attendance Records

NAME Institution NAME

Institution

Safaa ELMeneza Faculty of Medicine for girls, Al Azhar University

Ehab Abdel-Monem Al-

Banna Faculty of Medicine, Zagazig University

Mariam Abu-Shady

Faculty of Medicine for girls, Al Azhar University

Mohamed Ahmed Rowisha Faculty of Medicine ,Tanta University

Michael Weindling University of Liverpool, UK Iman El-Bagoury Faculty of Medicine for girls AL Azhar University

Sanaa Tantawy Faculty of Medicine for girls, AL Azhar University

Neveen Mohamed Abdel-Moneam Fayed

Helwan University

Hala Refaat El-kolaly Faculty of Medicine for girls, AL Azhar University

Mostafa Mohamed Awny Faculty of Medicine ,Tanta University

Mohamed Reda Bassiony Mansoura University Iman Yousri Mohamed Nile Badrawy Hospital

Gamal El-din Abdel-Hamid Faculty of Medicine AL Azhar University

Nahed Abdel-Mordy Kholief Nile Badrawy Hospital

Mohamed Nour el-Din MCH Ministry of Health Fatma Ali Mamdouh Nile Badrawy Hospital

Afaf Koraa Faculty of Medicine for girls,AL Azhar University

Ehsan Khaled Mohamed Nile Badrawy Hospital

Soheir Ibrahim Mohamed Faculty of Medicine for girls,ALAzhar University

Zeinab Nabil Said Faculty of Medicine, AL Azhar University

Mohamed El-Kalioby Faculty of Medicine Suez canal, University

Amal Kamal University Pediatrics Hospital of Mansoura

Eman Almorsy Ahmed

Faculty of Medicine for girls,ALAzhar University

Aesha Mohamed Saleh Aswan Hospital

Naema Ismail Faculty of Medicine for girls, AL Azhar University

Raghda Ali Ahmed Maher Teaching Hospital

Shimaa Hamdy Mohamed National Institute of Diabetes

Shima Mohamed Abdel-Salam

Helwan Hospital

Manal Mohamed Abdel-Mageed

El-Haram Hospital Amira Ali Tahaa Assem Ministry of Health hospital

Eman Khaled Faculty of Medicine AL Azhar University

Wesam Abdelmonem Faculty of medicine Zagazig University

Ashraf Mohamed Ibrahim Faculty of Medicine Tanta University

Mosallam Naser Faculty of Medicine ALAzhar University

Mervat Mohamed Ahmed Gamalel-Din

Ministry of Health hospital Abeer Ahmed Abdel-Hady Ministry of Health hospital

Amera Ali Abdel-Rahman Al-Fswa General Hospital Awatef Abdul-Hameed Al-Eefaey

Al-Zahraa Hospital

Zeinab Farag Aseiba Faculty of Medicine for girls Al Azhar University

Amal Gaber Mohamed Al-Zahraa Hospital

Ashraf Mohamed Ibrahim Faculty of Medicine Tanta University


Egyptian Neonatal Safety Standards 2014