ORDINANCE Nº 72, OF 11TH OF JANUARY, 2010

It is hereby established that the observance of the child and fetal death is mandatory in the public and private health services that integrate the Unified Health System (SUS).

THE STATE MINISTER OF HEALTH, in use of the powers ascertained by the section II, sole paragraph of the article 87 of the Constitution, and

Considering the Millennium Objective IV, which establishes the compromise of reducing in three-quarters the mortality table of children under five-years-old and that the greatest component of this mortality is child mortality, especially newborn mortality;

Considering that the real dimensioning of the child and fetal death in Brazil is complicated by the under-registration of deaths and the under-enumeration of child and fetal death;

Considering that the identification of the main risk factors associated with child and fetal mortality makes possible the definition of prevention strategies for new occurrences;

Considering that the Law n. 6.015 of 31st December 1973 establishes that no burial shall be done without an official death certificate;

Considering that the Death Declaration (DO) is the official document which attests the death of an individual and that the Information System on Mortality (SIM) is the official instrument from the Health Ministry for the information of the DO in all the national territory and that, as of 2006, it has more agility in the transmission of the information of the death;

Considering what is arranged in the Ordinance n. 116/GM of 11th February 2009, which regulates the amount of actions that constitute the SIM and the Information System on Live Births (SINASC);

Considering that the Death Declaration is a document of mandatory completion by doctors, with attributions and responsibilities detailed by the Resolution n. 1.779 of 2005 from the Federal Medicine Council,

Considering the predicted actions in the National Pact for the Reduction of Mother and Newborn Mortality, as released by the Presidency of the Republic on 8th March 2004 and approved in meeting of the Committee of Tripartite Inter-Managers (CIT) and the National Health Council (CNS);

Considering what is arranged in the Ordinance n. 1.172/GM, of 15th June 2004, which regulates competences of the Union, the States, the Municipalities and the Federal District in the area of Health Vigilance; among them, the surveillance and the monitoring of child and mother deaths;

Considering that the agility in the information and the opportune beginning of the investigation are fundamental factors for the action's success; and

Considering that the reduction of the child and fetal death is one of the priorities of this Ministry and, in order to achieve that goal, a series of measures have been implemented, as resolved:

Art. 1 It establishes that the vigilance of the child and fetal death is mandatory in the health services, both public and private, which integrate the Unified Health System (SUS).

§1th The vigilance of the child and fetal death is an attribution of the Epidemiological Vigilance National System.

§2th The active search, the investigation, the analysis and the monitoring of child and fetal deaths must be made by health professionals as designated by the Municipalities, States or the Federal District Health Secretaries.

Art. 2 In accordance to the finalities of this Ordinance, the relevant definitions are as follows:

I - Child death: it is that which occurs with children who were born alive, from the moment of birth until 1 incomplete year, it is, 364 (three-hundred and sixty-four) days;

II - live birth: it is defined as the expulsion or complete extraction from the mother's body (regardless of the pregnancy's duration) of a product of conception which, after the separation, breathes or presents any other life signal, such as heartbeats, pulsations of the navel string or effective movements of the voluntary contraction muscles, whether the navel string has been cut or not, or whether the placenta has been loosened or not. Each product of a birth which reunites these conditions is considered to be a child born alive; and

III - fetal death: it is the death of the product of conception before its expulsion or its complete extraction from the mother's body, having weighed at the moment of birth 500 grams or more. Whenever information about the weight at the moment of birth is not available, consider those in gestational age of 22 weeks (154 days) of gestation or more. Whenever information about the weight at the moment of birth and the gestational age is not available, consider those with body length of 25 centimeters or more from the head down to the ankle.

Art. 3 The child and fetal deaths are considered to be events of mandatory investigation by health professionals (from the vigilance in health or from the assistance to health), aiming at the identification of the determining factors and the subsidy of the adoption of measures that can prevent the occurrence of avoidable deaths.

Art. 4 For investigation purposes, the minimal case criteria are:

I - post-newbirth (from 28 days to 1 incomplete year or 364 days of life);

II - newbirth (from 0 to 27 days of life); and

III - fetal (stillborn).

Sole paragraph. Considering the lower prevention potential for deaths with grave, complex or lethal congenital malformation, its investigation is optional.

Art. 5 The base instruments which will serve as a guide for the investigation must be the ones standardized by the use of the State or Municipality, or the ones recommended by the publication "Manual of Child and Fetal Death Vigilance" by the Health Ministry or others which may be recommended by the Secretary of Health Vigilance (SVS/MS).

Art. 6 Sole paragraph. When the State or Municipality opts for using instruments for data collection which differ from the ones recommended by the Health Ministry, these must necessarily inform the constant queries in the Form of Investigation of the Child and Fetal Death according to the Annex I to this Ordinance and which will serve as a base document for feeding the death investigation module of the Information System on Mortality (SIM).

Art. 7 The death declarations containing information on child and fetal death must, under the terms of the Art 5, flow and follow constant deadlines from the Annex II to this Ordinance or the existing flow in each State Health Secretary, as long as the established deadlines for the abidance of this Ordinance are obeyed.

 § 1 The deadline for the service or the health professional to inform the death through the shipping of the first means of the DO is 48 (forty-eight) hours tops, counting from the occurrence date.

§ 2 The deadline for the State Health Secretary to release the register via SIM to the Health Ministry is 30 (thirty) days tops, counting from the occurrence date.

§ 3 The deadline for the conclusion of the mapping of the data which compounds the investigation, the accomplishment of the discussion, analysis and the conclusion of the case by the ones accountable for death vigilance and the shipping of the Form of Investigation of the Child and Fetal Death to the Municipality Health Secretary is 120 (one-hundred and twenty) days tops, counting from the occurrence date.

§ 4 The deadline for the ones accountable for death vigilance or the Municipality Health Secretary, according to local definition, to provide the feeding of the child and fetal death investigation module of SIM with the data from the Form of Investigation of the Child and Fetal Death is 7 (seven) days tops, counting from its receipt date.

§ 5 The deadline to update the SIM with data originating from the Form of Investigation of the Child and Fetal Death, including alterations of the causa mortis as duly recodified and re-selected whenever plausible, as well as the transfer of the altered register and its availability to the Health Ministry, is 30 (thirty) days after the conclusion of the investigation dealt with on § 3.

Art. 8 It establishes that the public and private health services which integrate the SUS shall carry out an active search, on a daily basis, of child and fetal deaths, occurred or attested in their dependencies and guarantee the flows and deadlines established in this Ordinance.

Sole Paragraph. Hospitals where there is a Hospital Epidemiology Nucleus (NHE) or hospital death implanted commissions or committees, these can carry out the attributions according to what is established in this article's caput.

Art. 9 It defines that the hospitals, medical surgeries and basic health units, or any other public or private health service which integrate the SUS, where the pregnant or parturient woman or the child has been assisted, shall release to the accountable for the child and fetal deaths investigation access to the medical records within the deadline of 48 (forty-eight) hours after the request in order to make possible the opportune beginning of the child and fetal deaths investigation.

§ 1 The accountable ones for the child and fetal deaths investigation shall use that material to collect data, transcribing them to the very instrument used in the investigation in accordance to the Art. 6 of this Ordinance.

§ 2 Considering that the information contained in the medical records are protected by secrecy, the accountable ones for the child and fetal deaths investigation must guarantee the secrecy and the privacy of the patients, following the ethical precepts in practice as established by the Art. 154 and by the Art. 269 of the Criminal Code, and by the Art. 102 of the Medical Ethics Code.

Art. 10. It determines that the conclusion of the death investigation is an attribution of the accountable ones for the death vigilance of the Municipality where the stillborn's or the deceased child's mother resides; the investigation shall be supported by the accountable ones for the death vigilance of the Municipality where the pregnant or parturient woman, or the child, was/were assisted or passed away, in case the assistance or the passing has/have occurred outside the residence Municipality.

Art. 11 It determines that the General Co-ordination of Epidemiological Information and Analysis of the Department of Analysis of the Health Situation, of the Secretary of Health Vigilance (CGIAE/DASIS/SVS/MS) shall release, every fortnight, to the Technical Area of Child Health and Breast-Feeding, of the Department of Strategic Programmatic Actions, of the Secretary of Health Attention (DAPES/SAS/MS) and to the Center of Strategic Information on Health Vigilance (CIEVS/SVS/MS), in the internal net of the MS, the updated extract of child and fetal deaths as notified to the SIM. Sole paragraph. The same determination refers to the corresponding components in the States and Municipalities.

Art. 12 It establishes that the CGIAE/DASIS/SVS/MS along with the CIEVS/SVS/MS and the Technical Area of Child Health and Breast-Feeding/DAPES/SAS shall carry out the monitoring of national data, granting accesses with specific reaches for managers and citizens.

Art. 13 It will be the responsibility of the Secretary of Health Vigilance, of the Secretary of Health Attention and of the Department of Computer Science from SUS (DATASUS) to supply with technical and management support in order to make operational the aforementioned Articles in this Ordinance.

Art. 14 This Ordinance has effect as of its date of publication.

JOSÉ GOMES TEMPORÃO

ANNEX I

FORM OF INVESTIGATION OF THE CHILD AND FETAL DEATH - SYNTHESIS, CONCLUSIONS AND RECOMMENDATIONS

Standard form with the synthesis of the child and fetal death investigation to be mandatorily adopted as instrument of collect to feed the module of deaths investigation of SIM, in order to inform the synthesis of each investigation.

Case identification data:

A) DO number:

B) Municipality/State of family residence:

C) Municipality/State of death occurrence:

Part I: Case investigation

1. Moment of death in relation to the parturition: (1)Before (2)During (3)After (9)Unknown

1.1. Birth date: ____ / ____ / ______

1.2. Death date and time: ____ / ____ / ______ Time: ___:____

1.3. Age at the time of death: ______ ( ) minutes, ( ) hours, ( ) days, ( ) months, ( ) years

2. Sources of the investigation's information (tick more than one if necessary):

(1)Interview at home (2) Ambulatory medical records (3) Hospital medical records (4) SVO (5) IML (6) Urgency/emergency reception records

3. Health facility (ies) where the prenatal was done: (1)Non-applicable, for the prenatal was not done

3.1. Name: _______________ CNES Code: ___________________

Name: __________________ CNES Code: __________________

Name: __________________ CNES Code: ___________________

3.2. Gestational age when the first medical appointment was made: in weeks or months (9) Ignored

4. Parturition place: (1) Hospital (2) Home (3) Thoroughfare (4) Commuting to the health service (9) Ignored

4.1. Health facility where the parturition or abortion took place

Name: _________________ CNES Code:___________________

4.2. A partograph was used during parturition: (1) Yes (2) No (3) Non-applicable

4.3. A quick test for syphilis was applied (VDRL): (1) Yes (2) No (3) Non-applicable

5. The child was monitored in basic care: (1) Yes (2) No (3) Non-applicable

5.1. Health facility where the child was monitored: (3) Non-applicable

Name: ________________ CNES Code: ___________________

5.2. The vaccination was up-to-date: (1)Yes (2)No (3)Non-applicable

6. Has the investigation altered or corrected the causa mortis? (1) Yes (2) No

7. Death causes after investigation

PART I

Line a): ________________________________________

Line b): ________________________________________

Line c): ________________________________________

Line d): ________________________________________

PART II

Basic cause after investigation

8. Has the investigation altered or corrected another field of the Death Declaration besides the causa mortis? (1) Yes (2) No

8.1. Have the fields of the Block V of the Death Declaration been altered and which alterations were these? (1) Yes (2) No

Field ____ Original _______ After investigation ______________

Field ____ Original _______ After investigation ______________

Field ____ Original _______ After investigation ______________

8.2. Have other fields of the Death Declaration been altered and which fields were these? (1) Yes (2) No

Field ____ Original _______ After investigation ______________

Field ____ Original _______ After investigation ______________

Field ____ Original _______ After investigation ______________

9. Has the investigation altered or corrected any fields of the Newborn Declaration? (1) Yes (2) No

9.1. Which fields and alterations?

Field ____ Original _______ After investigation ______________

Field ____ Original _______ After investigation ______________

Field ____ Original _______ After investigation ______________

Part II: Case analysis

10. Were any problems identified after the investigation ? (1) Yes (2) No

Tick the most adequate alternative in relation to the access or assistance fault:

10.1. Family planning (1) Yes (2) No (3) Inconclusive

10.2. Prenatal (1) Yes (2) No (3) Inconclusive

10.3. Parturition assistance (1) Yes (2) No (3) Inconclusive

10.4. Assistance to the newborn in the maternity hospital (1) Yes (2) No (3) Inconclusive (4)Non-applicable

10.5. Assistance to the child in the Health Center / UBS (1) Yes (2) No (3) Inconclusive (4)Non-applicable

10.6. Assistance to the child in the urgency (1) Yes (2) No (3) Inconclusive (4)Non-applicable

10.7. Assistance to the child at the hospital (1) Yes (2) No (3) Inconclusive (4)Non-applicable

10.8. Family difficulties (1) Yes (2) No (3) Inconclusive

10.9. External causes (1) Yes (2) No (3) Inconclusive (4)Non-applicable

10.10. System organization / health service

Primary care coverage (1) Yes (2) No (3) Inconclusive

Reference and counter-reference ((1) Yes (2) No (3) Inconclusive

High-risk prenatal (1) Yes (2) No (3) Inconclusive

IUC bed - pregnant woman ((1) Yes (2) No (3) Inconclusive

IUC newborn beds (1) Yes (2) No (3) Inconclusive

Regulation central (1) Yes (2) No (3) Inconclusive

Inter-hospital transportation ((1) Yes (2) No (3) Inconclusive

Blood banks (1) Yes (2) No (3) Inconclusive

11. Could this death have been avoided? (1) Yes (2) No (3) Inconclusive

12. Tick the avoidance classification for this case (more than one classification may be ticked):

Wigglesworth (1)W1 (2)W2 (3)W3 (4)W4 (5)W5 (6)W6 (7)W7 (8)W8 (9)W9

SEADE (1)S1 (2)S2 (3)S3 (4)S4 (5)S5 (6)S6 (7)S7 (8)S8

Brazilian list (1)1.1 (2)1.2.1 (3)1.2.2 (4)1.2.3 (5)1.3 (5)1.4 (6)2 (8)3

13. Case conclusion date:

ANNEX II

SPECIAL FLOW FOR DEATH DECLARATIONS WITH INFORMATION REGARDING CHILD AND FETAL DEATHS

The death declarations with information regarding child and fetal deaths must flow and follow special deadlines as described below, or they must follow the existing flow in each State Unit (UF) as long as the deadlines established for this Ordinance's abidance are obeyed:

1. The hospital or service where the death took place or that issued the Death Declaration issues its first draft in at least 48 (forty-eight) hours to the municipality manager of the Information System on Mortality (SIM).

2. The sector that processes the data on deaths occurred in the Municipality issues in 48 (forty-eight) hours tops the DO's first draft to the ones accountable for child and fetal death vigilance of the Municipality Health Secretary (SMS), Regional or State Health Secretary (SES), according to the defined flow in each place, which corresponds to 96 (ninety-six) hours after the death tops.

3. The accountable ones for child and fetal death vigilance of SMS begin the investigation immediately, in accordance with the routines and flows agreed with SES in each State, using the available sources and the standardized investigation instruments for usage in the State or Municipality, or the standard-instruments recommended by the publication "Manual of Child and Fetal Death Vigilance" by the Health Ministry or others which are recommended by the Secretary of Health Vigilance (SVS/MS).

4. When the State or the Municipality opts for the usage of instruments for data collect that are different from those recommended by the Health Ministry, these must mandatorily inform the queries contained in the FORM OF INVESTIGATION OF THE CHILD AND FETAL DEATH - SYNTHESIS, CONCLUSIONS AND RECOMMENDATIONS (ANNEX I), which will serve as a base document to feed the death investigation module of SIM.

5. Simultaneously to the routing of the DO to the accountable ones for child and fetal death vigilance, the sector which processes the mortality data of the deaths occurred in the Municipality codifies the causes in the death declaration and inputs the data in the SIM's application, informing at that moment the original content of the DO, and that the death is not investigated.

6. The SES will agree on the flux with the SMS so as to guarantee that the data inserted in the SIM are transferred via SISNET (from the level which is considered to be the most appropriate - municipality, regional, or state) in the deadline of 30 (thirty) days after the death tops, ensuring that this data will be available at the state and federal bases immediately as of that moment;

7. The accountable ones for child and fetal death vigilance must conclude the case and inform the death investigation results in 120 (one-hundred and twenty) days after the death date.

8. Informing the investigation result means routing it to the sector which processes mortality data of the deaths occurred in the Municipality, the  FORM OF INVESTIGATION OF THE CHILD AND FETAL DEATH - SYNTHESIS, CONCLUSIONS AND RECOMMENDATIONS (ANNEX I) fully filled out.

9. The sector which processes the mortality data of the deaths occurred in the Municipality will type the child and fetal death investigation synthesis in the death investigation module of SIM, as offered by MS in digital application whose data input screen is based on the FORM OF INVESTIGATION OF THE CHILD AND FETAL DEATH - SYNTHESIS, CONCLUSIONS AND RECOMMENDATIONS (ANNEX I) in 7 (seven) days tops after the receipt of the Form. The Form can be made available so that the accountable ones for child and fetal death vigilance feed the aforementioned module, according to the decision of each place.

10. In case the investigation shows the need to change or complement the Newborn Declaration (DN) or the DO, these must be done. In case of alteration/update of the death causes, they must undergo a recodification process and a new selection of the basic cause. Another type of alteration is related to the individual's age at the moment of death, which can generate revisions in the type of death classification in the SIM (fetal or non-fetal).