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RS 832.102.4 Order of June 23, 1999, on the Quality Assurance of Breast Cancer Screening Programs by Mammography

Original Language Title: RS 832.102.4 Ordonnance du 23 juin 1999 sur la garantie de la qualité des programmes de dépistage du cancer du sein réalisé par mammographie

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832.102.4

Quality Assurance Guidelines for Breast Cancer Screening Programs by Mammography

On 23 June 1999 (Status on 31 August 1999)

The Swiss Federal Council,

See art. 58, para. 3, of the Federal Health Insurance Act of March 18, 1994 1 ; see art. 77, para. 3, of the Order of June 27, 1995, on Medicare 2 ,

Stops:

Section 1 General provision

Art. 1

The provisions of this Order set out the minimum requirements for breast cancer screening programs under s. 12, let. 2, of the Order of 29 September 1995 on the provision of care insurance 1 .


Section 2 Eligibility for program participants

Art. 2 Program

1 A single screening programme shall be in place for a given territory at the cantonal or inter-cantonal level in order to achieve the optimum level of participation necessary for the purpose of preventing breast cancer in that territory.

2 A minimum of eight years must be guaranteed.

3 The program is led by an organization under s. 3.

Art. 3 Organizations

1 Organisations implementing the programme provided for in this Ordinance shall be recognised by a canton or, jointly, by several cantons. In particular, these organisations must demonstrate that they have the resources to carry out their tasks.

2 Organizations agree to participate in the benefit provider program that meet the minimum conditions set out in this order.

3 They monitor each year that these conditions are met and decide on the continuation or revocation of the participation of the benefit provider in the program.

4 They regulate the details of the principles set out in s. 4, 7 and 10, after hearing the specialized organizations.

5 They may provide for an introductory phase and transitional conditions for participation in the programme. This phase of introduction cannot exceed two years.

Art. 4 Physicians specializing in medical radiology

1 Physicians who perform and read mammography must be specialized in medical radiology and have undergone a training course on screening mammography recognized by the specialized medical society.

2 They must carry out and read a minimum number of screening mammograms per year.

3 They are required to participate in the quality promotion process as defined by s. 10. They must also demonstrate that the quality of their readings meets the parameters (performance indicators) recommended by the European Guidelines for quality assurance in mammography screening. 2nd edition) 1 .

4 The Federal Department of the Interior has the authority to update the changes to the European Union guidelines.


1 These guidelines can be obtained at the Federal Office of Public Health, 3003 Berne

Section 3 Programme organization

Art. 5 Invitation

1 The organization has a written invitation to conduct screening mammography for women as early as 50 years. This invitation provides information and explanations on the risks of breast cancer and the exact meaning of the mammogram result.

2 The invitation must also indicate the right to an explanatory interview and advice as provided for in Art. 6.

Art. 6 Explanatory memorandum and advice

1 Explanatory maintenance and advice can be carried out by a specialist doctor in gynecology or by the doctor dealing with the insured.

2 If the insured renounces this interview, it means in writing to the organization.

Section 4 Performance and Reading of Mammography

Art. 7 Apparatus

1 The equipment used must comply with the European Guidelines for quality assurance in mammography screening, 2nd edition 1 , as updated by the Federal Department of the Interior.

2 This compliance must be monitored periodically.


1 These guidelines can be obtained at the Federal Office of Public Health, 3003 Berne

Art. 8 Reading mammography

1 The medical radiology physician who performed the mammogram transmits to the organization the photographs and the minutes of its reading. The organization loads a medical doctor specializing in medical radiology independent of the first, of a second reading.

2 When the results of the two readings diverge, the organization submits them for a third reading to a medical radiology specialist independent of the first two and who is particularly experienced. Its opinion is considered to be a definitive expert opinion. A consensus session between the first two readers can be arranged, instead of a third reading.

Art. Communication of results

1 The organization transmits the results of mammography to the insured at the latest eight days after the examination.

2 It shall indicate where appropriate the need to consult a specialist doctor in gynecology or the attending physician to carry out the necessary diagnostic or therapeutic measures.

Section 5 Promotion of quality

Art. 10

1 Programs should include the following:

A.
An external, standardized and semi-annual monitoring of the quality of readings;
B .
Quarterly case discussion seminars to ensure the development process for physicians participating in the program;
C.
An annual evaluation of the quality of the readings of each doctor participating in the programme according to the parameters (performance indicators) recommended by the guidelines of the European Union of 1996 (European Guidelines for quality assurance In mammography screening, 2nd edition) 1 .

2 The organization prepares an annual report for the Federal Office of Public Health 2 On the implementation of the quality promotion programme.


1 These guidelines can be obtained at the Federal Office of Public Health, 3003 Berne
2 The designation of the administrative unit has been adapted according to Art. 4 A O of June 15, 1998 on Official Publications (RS 170.512.1 ).

Section 6 Entry into force

Art. 11

This order shall enter into force on 1 Er July 1999.



RO 1999 2168



Status August 31, 1999