> Examinations in pregnancy. The Protocol S. S. N.

M. D. 10 SEPTEMBER 1998 Update of the d.m. 6 march 1995 concerning the update of d.m. 14 April 1984 laying down the protocols of access to laboratory tests and diagnostic instruments for women in state of pregnancy and to the protection of maternityà. (Published in the Official Journal on 20 October 1998, n. 245)

No. 1

1. Are excluded from participation in the cost, pursuant to art. 1, paragraph 5, letter a) of legislative decree of April 29 1998, no. 124, the performance of diagnostic equipment and laboratory and other specialized services for the protection of maternityà indicated in this decree and annexes A, B, and C, which form an integral part, consumed at the public health facilities and accredited private, including family planning clinics. Are however excluded from participation in the cost of the regular medical examinations ostetricoginecologiche.

2. The prescription of the performance of diagnostic equipment and laboratory and other specialist services is carried out by general practitioners or by specialists working in the accredited structures, public or private, including family planning clinics. The prescription of the specialist is mandatory in the cases provided for by art. 2, and annexes A, B, and C .

Art. 2

1. In function preconcezionale are excluded from participation in the cost-performance of diagnostic equipment and laboratory and other specialized services that are necessary to ascertain any genetic defects, prescribed by the specialist to the couple, if the history of reproductive or family of the couple shows the conditions of risk to the fetus.

2. Are excluded from participation in the cost-performance of diagnostic equipment and laboratory and other specialist services necessary and appropriate for the pathologic conditions that carry a risk for maternal or fetal, prescribed usually by the specialist.

3. Are excluded from participation in the cost-performance of diagnostic equipment and laboratory and other specialist services, as necessary and appropriate for the prenatal diagnosis, in the specific conditions of fetal risk indicated in the annex C, prescribed by the specialist among those included in the ministerial decree of 22 July 1996, published in the

the Official Gazette, ordinary supplement n. 150, September 14, 1996. Regions  identify the structures of reference for the execution of such performance, ensuring that the same provide to women and to couples appropriate support.

4. In the presence of risk conditions referred to in this article, the provisions of diagnostic equipment and laboratory and other specialist services must indicate the diagnosis, or the diagnosis is suspected.

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Art. 3

1. This decree replaces the decree of 6 march 1995 of the Minister of the sanità, published in the Official Journal no. 87 of 13 April 1995.

Art. 4

1. The present decree will be sent to the Court of auditors for registration and published in the Official Journal of the Italian Republic.

Rome, September 10, 1998

The Minister of the Sanità

________________________________________________________________________________

Allegato A

SPECIALIST services FOR THE PROTECTION OF MATERNITYÀ HEAD of, EXCLUDED FROM PARTICIPATION in THE COST FUNCTION PRECONCEZIONALE

1. Specialist services for women

89.01 ANAMNESIS AND EVALUATION, DEFINED SHORT: gynecological visit preconcezionale

90.49.3 ANTIBODIES ANTI-ERYTHROCYTE Test (Coombs ‘ indirect): in case of risk of isoimmunisation

91.26.4 VIRUS ROSOLIA ANTICORPI (Ig G, IgM)

91.09.4 TOXOPLASMA ANTICORPI (E.I.A.) (IgG, Ig M)

90.62.2 EMOCROMO: Hb, GR, GB, HCT, PLT, IND. DERIVED., F. L.

90.74.3 RESISTANCE OSMOTIC ERYTHROCYTE (Test of Simmel): in the case of a reduction of the cell volume average and morphological alterations of the erythrocytes

90.66.5 Hb – ABNORMAL HEMOGLOBINS (HbS, HbD, HbH, etc): in the case of a reduction of the cell volume average and morphological alterations of the erythrocytes

91.38.5 ES. CYTOLOGICAL CERVICO-VAGINAL (PAP test)

2. The specialist for men

90.62.2 BLOOD count: Hb, GR, GB, HCT, PLT, IND. DERIV., F. L.: in the case of a woman with phenotype heterozygous for hemoglobinopathies

90.74.3 RESISTANCE OSMOTIC ERYTHROCYTE (Test of Simmel): in the case of a woman with phenotype heterozygous for hemoglobinopathies

90.66.5 Hb – ABNORMAL HEMOGLOBINS (HbS, HbD, HbH, etc): in the case of a woman with phenotype heterozygous for hemoglobinopathies

3. Specialized services for the couple

91.22.4 VIRUS IMMUNODEF. ACQUIRED [HIV 1-2] ANTICORPI H

90.65.3 ABO BLOOD GROUP and Rh (D)

91.10.5 TREPONEMA PALLIDUM ANTIBODIES (Quest quantity. By emoagglutin. Passive) [TPHA]

91.11.1 TREPONEMA GRAY ANTICORPI ANTI CARDIOLIPINA (Flocculazione) [VDRL] and [RPR]

4. In the case of abortività repeated or previous pathologies of pregnancy with perinatal death and on prescription of a specialist obstetrician or geneticist:

89.01 ANAMNESIS AND EVALUATION, DEFINED SHORT: genetic Counseling

88.79.7 ULTRASOUND TRANSVAGINALE

68.12.1 HYSTEROSCOPY Excludes: Biopsy with dilatation of the cervical canal.

68.16.1 BIOPSY OF the BODY of the UTERUS: endoscopic Biopsy (hysteroscopy) of the endometrial lining

90.46.5 ANTICOAGULANTE WOLF-LIKE (MILK)

90.47.5 ANTICORPI ANTI CARDIOLIPINA (IgG, IgA, IgM)

90.51.4 ANTIBODIES to MICROSOMES (AbTMS) OR ANTI TIREOPEROSSIDASI (Slpi)

90.54.4 ANTIBODIES ANTI-THYROGLOBULIN (AbTg)

91.31.2 KARYOTYPE FROM METAPHASES LYMPHOCYTE 1 Technique of banding (Resolution not less than 320 bands): the pair

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__________________

Note: we Have reported the performance as defined by the D. M. 22 July 1996 laying down the «Performance

expert assistance ambulatory payable under the national health Service, and

rates» with the related identification codes and markings. The letter «H» refers to performance

delivered in clinics located at other institutions, hospitalization or surgeries that are protected.

________________________________________________________________________________

Allegato B

SPECIALIST services FOR THE CONTROL OF PREGNANCY PHYSIOLOGICAL, EXCLUDED FROM PARTICIPATION in THE COST

At the beginning of the pregnancy, possibly before the 13ª week, and for the first control:

90.62.2 EMOCROMO: Hb, GR, GB, HCT, PLT, IND. DERIVED., F. L. H

90.65.3 ABO BLOOD GROUP and Rh (D), if not run in a function preconcezionale

90.09.2 ASPARTATO AMINOTRANSFERASI (AST) (GOT) [S]

FIELD 90.04.5 aminotransferase (Alt) (GPT) [S/U]

91.26.4 VIRUS RUBELLA ANTIBODIES: in the case of IgG negative, by the 17ª week

91.09.4 TOXOPLASMA ANTIBODIES (E. I. A.): in the case of IgG negative repeat every 30-40 days until delivery

91.10.5 TREPONEMA PALLIDUM ANTIBODIES (Quest quantity. by emoagglutin. passive) [TPHA]: if not performed in the function preconcezionale extended to the partner

91.11.1 TREPONEMA PALLIDUM ANTIBODIES ANTI CARDIOLIPIN (Flocculation) [VDRL] and [RPR]: if not performed in the function preconcezionale extended to the partner

91.22.4 VIRUS IMMUNODEF. ACQUIRED [HIV 1-2] ANTICORPI

90.27.1 GLUCOSIO [S/P/U/dU/La]

90.44.3 URINE EXAMINATION CHEMICAL, PHYSICAL AND MICROSCOPIC

88.78 OBSTETRIC ULTRASOUND

90.49.3 ANTIBODIES ANTI ERYTHROCYTES [Test Coombs indirect]: in the case of women Rh negative is at risk of immunization, the test should be repeated every month; in the case of incompatibilità AB0, the test should be repeated at 34ª-36ª week.

Between 14ª, and 18ª week:

90.44.3 URINE EXAMINATION CHEMICAL, PHYSICAL AND MICROSCOPIC (*)

Between 19ª, and 23ª week:

90.44.3 URINE EXAMINATION CHEMICAL, PHYSICAL AND MICROSCOPIC (*)

88.78 OBSTETRIC ULTRASOUND

Between the 24ª and the 27ª week:

90.27.1 GLUCOSIO [S/P/U/dU/La]

90.44.3 URINE EXAMINATION CHEMICAL, PHYSICAL AND MICROSCOPIC (*)

Among the 28ª, and 32ª week:

90.62.2 EMOCROMO: Hb, GR, GB, HCT, PLT, IND. DERIVED., F. L.

90.22.3 FERRITIN [P/(Sg)Er]: in the case of a reduction of the volume of the globular middle

90.44.3 URINE EXAMINATION CHEMICAL, PHYSICAL AND MICROSCOPIC (*)

88.78 OBSTETRIC ULTRASOUND

Among the 33ª and the 37ª week:

91.18.5 HEPATITIS B VIRUS [HBV] ANTIGENE HBsAg

91.19.5 VIRUS EPATITE C [HCV] ANTICORPI

90.62.2 EMOCROMO: Hb, GR, GB, HCT, PLT, IND. DERIVED., F. L.

90.44.3 URINE EXAMINATION CHEMICAL, PHYSICAL AND MICROSCOPIC (*)

91.22.4 VIRUS IMMUNODEF. ACQUIRED [HIV 1-2] ANTIBODIES in the case of anamnestic risk factors

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Among the 38ª, and 40ª week:

90.44.3 URINE EXAMINATION CHEMICAL, PHYSICAL AND MICROSCOPIC (*)

By the 41ª week:

88.78 OBSTETRIC ULTRASOUND: at the specific request of the specialist

75.34.1 CARDIOTOCOGRAPHY: at the specific request of the specialist; if necessary, monitor until birth

__________

(*) In case of bacteriuria is significant:

90.94.2 EXAMINATION of the CULTIVATION OF the URINE [urine culture] full Search of micro-organisms and pathogenic yeasts. Included: bacterial count.

In the case of threatened abortion include all the specialist services required for the monitoring of the evolution of the pregnancy.

Note: we Have reported the performance as defined by the D. M. 22 July 1996 laying down the «the provision of specialist care outpatient payable in the context of the national health Service, and tariffs», with related identification codes and markings. The letter «H» means benefits payable in the outpatient clinics located at the institutions, hospitalization or surgeries that are protected.

________________________________________________________________________________

Allegato C

DIRECTIONS TO PRENATAL DIAGNOSIS

(derived from the «Guidelines for genetic testing» approved by the National Committee for Biosafety and Biotechnology of the Presidency of the Council of Ministers)

The indications for prenatal diagnosis fall into two broad categories:

1. the presence of a risk-procreative predictable a priori: age; advanced maternal, the carrier parent heterozygous for chromosomal abnormalities, structural, parents who are carriers of gene mutations;

2. the presence of a fetal risk became obvious in the course of pregnancy: malformations, highlighted by the ultrasound examination, infectious diseases have arisen in pregnancy, positività of the biochemical tests for chromosomal abnormalities, familiarà for genetic diseases.

The indications for the investigation of cytogenetic for chromosomal abnormalities of a fetus are:

– età advanced maternal (= or > 35 aa.)

– parents with previous child affected by a chromosomal pathology

– the parent carrier of a structural rearrangement not associated with phenotypic effect

– the parent with aneuploidy of the sex chromosomes are compatible with the fertilityà

– abnormalities of fetal malformations highlighted sonographically

– probabilityà of 1/250 or greater that the fetus is affected by Down Syndrome (or other aneuploidy) on the basis of the biochemical parameters assessed on maternal blood or ultrasound, carried out with specific programmes of regional centres identified by the Regions and subjected to continual verification of the qualityà


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