PUBLICA HEALTH

Regulation of Act No. 22,853

DECRETO

N° 507

Bs. As., 8/4/86

VISTO Act No. 22.853, which establishes basic requirements for the establishment and operation of medical care units to apply dialysis in the treatment of kidney failure, and

CONSIDERING:

That the Ministry of Health and Social Action - Undersecretary of Health Resources - has projected regulatory correspondence.

Therefore,

THE PRESIDENT

OF ARGENTINA NATION

RIGHT:

ARTICLE 1 Approve the body of attached provisions which constitutes the regulation of Act No. 22.853, which as Annex I is an integral part of this decree.

ARTICLE 2°- Please refer to the Ministry of Health and Social Action to dictate the complementary, clarification or interpretative rules that require the application of the body of regulatory rules that are adopted.

ARTICLE 3 Contact, post, give to the National Directorate of the Official Register and archvese.



Article 1 - Not regulated.

Article 2 - Not regulated.

Article 3° ­ As the minimum conditions for its further empowerment and operation, extracorporeal and intracorporeal dialysis units shall have the elements to ensure the permanent compliance with the requirements set out below:

A ONE OF EXTRACORPOREA DIALISIS

I - Physical Infrastructure

(a) Local or local dialysis application with a surface of seven (7) square meters for each of the patients simultaneously dialled. This area refers to the one occupied by the patient and the dialysis equipment, excluding the spaces for machinery for the treatment of water, deposit of materials, wardrobes, bathrooms, etc.

(b) The walls as a whole and the floors of the premises indicated in subparagraph (a) should be covered or painted with material that ensures their impermeability and facilitates their cleanliness and disinfection.

(c) Insulated premises, with own bathroom, for dialysis of infected-contagious patients and especially with hepatitis B. This place will have a surface of seven (7) square meters and walls and floors covered or painted entirely with material that ensures its impermeability and facilitates its cleaning and disinfection.

II - Medical equipment and equipment

(a) Machines and/or devices for the application of dialysis, provided with indicators for the control of the efferent blood pressure of the dialysis, temperature, conductivity, bath flow and bubble detectors; they must possess alarm systems.

(b) Oscilloscope, electrocardiograph, defibrillator, laryngoscope and mechanical respiratory aid in the dialysis unit.

(c) Water treatment equipment to allow water for resistivity not less than 100,000 Ohms.

III - Disposable and/or reusable material

(a) Non-reusable disposable material: Needles, venous and arterial guides, heparinization guides and syringes. Reuse is prohibited.

(b) Reusable disposable material: Diallizing membranes, each of which can be used up to a maximum of three (3) dialytic depuration procedures, except when there is a technology approved by the agencies that control compliance with this law, which allows correct washing, sterilization, measurement of its volume or residual function and storage, in which the number of reuses can be increased.

For this purpose, the following requirements shall be fulfilled:

1 - General requirements

(a) Availability of purified water for the cleaning and washing of the dialer and preparation of all solutions.

(b) Technical procedure to ensure proper cleaning and washing of the dialer prior to re-sterilization.

c) Control of sterility by cultivation in one percent (1 percent) of all reused dialysts per month and subsequent registration.

(d) Pre and post-dialysis body temperature should be recorded and measured, or in the presence of chills or fever symptoms in each treatment to establish the presence of pyrogenic reactions.

(e) An exclusive storage sector should be available for reuse units, which are perfectly identified for each patient, with a temperature of between ten (10o) and twenty-five (25o) degrees centigrade.

2 - Specific requirements for each type of Hemodializer

(a) Hollow fibre dializer:

1 - The documentation that credits the residual volume of successive reuses must be retained.

2 . The dialling unit can be used as its residual volume equals 80 per cent (80 per cent) of its initial volume.

(b) Flat or coil sliders:

1 - The documentation that credits the initial value of urea or creatinine depuration of the unit considered shall be retained.

2 The procedure to be used to establish the debugging capacity of the dialer shall be documented.

3 . A record should be maintained containing the residual depuration capacity of urea or creatinine in the successive reuses of the unit used.

4 . The dialing unit can be used as long as it maintains 90 percent (90 %) of the initial functional capacity measured by urea or creatinine depuration.

IV - Staff

1 -

(a) A physician responsible for the unit: Specialist in nephrology with an experience not less than two (2) years in dialytic treatments.

(b) Other doctors, nephrologists or experienced not less than six (6) months in dialytic treatment.

The strength of each unit ' s professional staff should be sufficient to ensure permanent medical care during its working hours and/or as long as patients are in the process of dialysis and/or under circumstantial care due to eventual intercurrence.

If there are doctors resident in nephrology incorporated into the unit, they must have a minimum experience of three (3) months in dialytic treatments to be considered personal of the unit.

(c) Seologically, for the detection of antihygienic markers of the hepatitis B virus, all medical personnel of the unit. Negative personnel should be studied every three (3) months. In addition, this staff may be protected by active immunization with antihepatitis B vaccine.

2-

(a) Nurses and/or nurses who certify this status by certificate of studies approved by competent authority and who have also approved a complementary course of specialization in a dialysis unit, recognized by competent authority. This last requirement can be ignored if a continuous performance of six (6) months is credited at least in a dialysis unit.

(b) Infirmary assistants who credit this character through certificate of studies approved by competent authority and who have also approved a complementary course of specialization in a dialysis unit recognized by competent authority. This requirement can be ignored if the continuous performance of one (1) year is credited to a dialysis unit at least. Nurses and/or nurses are to be assisted by nurses and/or nurses under their supervision.

(c) Infirmary staff who, at the time of application of this Act, are eligible for pre-approval units without meeting the requirements set out in points (a) or (b), may continue in service provided that they credit, in judgment and under the responsibility of the head of the unit, sufficient suitability for the performance of their duties; otherwise they must be applied to other tasks. In any case, the availability of one (1) nurse or one (1) nursing assistant for every three (3) patients in simultaneous dialysis process will be required.

(d) Serologic research should be made for the detection of antigenic markers of the hepatitis B virus, to all nurses, technicians and cleaning personnel. Negative personnel should be studied every three (3) months. This staff may also be protected by active immunization with B-hepatitis vaccine.

V - Diagnosing Patients

(a) Ambulatory chronic kidney patients should be dialed in separate premises of those dedicated to renal patients with septic or infect-contagious diseases, be ambulatory or interned.

In the event that the patient requires him/her for medical and/or psychological reasons, he/she may choose to perform the intra or extracorporeal dialysis at his/her home, provided that the treatment dialysis unit certifies that he/she is fit to carry out the selected procedure and ensures the responsibility of serious and urgent medical control.

(b) Clinical history of hepatitis B should be collected for dialysis patients. They should also be researched serologically for the detection of antigenic markers of the hepatitis B virus. Negative patients should be studied on a monthly basis and may be protected by active immunization with antihepatitis B vaccine. Positive patients to any antigenic marker or hepatitis B, or with a clinical history of hepatitis should be dialed in a separate location for isolation.

INTRACORPOREA PERITONEAL DIALISIS

As minimum conditions for enabling and operating, the intracorporeal dialysis units must have the elements to ensure that the following requirements are met permanently:

I... physical infrastructure

(a) Two premises of nine (9) square meters each with a common bathroom, dedicated exclusively to the peritoneal dialysis procedure. One of these premises is intended for the teaching of the procedure or the application of the peritoneal dialysis and the other for the outpatient control of the patients in treatment.

(b) In the case of premises for the simultaneous treatment of more than two patients, the area for each should not be less than seven (7) square metres.

(c) Insulated premises, with own bathroom, for dialysis of infected-contagious patients and especially with hepatitis B. This place will have a surface of seven (7) square meters and walls and floors covered or painted entirely with material that ensures its impermeability and facilitates its cleaning and disinfection.

II - Of the appliances

(a) The peritoneal dialysis procedure may be performed manually or mechanically, and therefore it is not essential to have special equipment.

(b) Electrocardiograph oscilloscope, defibrillator, laryngoscope and mechanical respiratory assistance equipment. When these devices are available in the extracorporeal dialysis unit, in intensive therapy or in the coronary unit, in the vicinity of the peritoneal dialysis unit, it will not be necessary to have them inside the premises of the latter. Otherwise, these devices should be available in the area of the peritoneal dialysis unit.

III.

1 -

(a) A physician responsible for the unit as a specialist in nephrology granted by competent authority and experience in dialectical treatment of two (2) years.

(b) Other nephrologists or experienced not less than six (6) months in dialysis.

The professional staffing of each unit should be sufficient to ensure permanent medical care during its working hours and/or while patients are in the process of dialysis and/or under circumstantial care due to eventual occurrences. Doctors living in nephrology incorporated into the unit must have a minimum experience of three (3) months in dialysis treatment to be considered staff of the unit.

(c) Seologically, for the detection of antigenic markers of the hepatitis B virus, all medical personnel of the unit. Negative personnel should be studied every three (3) months. In addition, this staff may be protected by active immunization with antihepatitis B vaccine.

2-

(a) Nurses and/or nurses who certify this status by certificate of studies approved by competent authority and who have also approved a complementary course of specialization in a dialysis unit, recognized by competent authority. This last requirement can be ignored if the continuous performance of three (3) months is credited at least in a peritoneal dialysis unit.

(b) Infirmary assistants who prove this by certificate of studies approved by competent authority and who have also approved a complementary course of specialization in a dialysis unit, recognized by competent authority. This requirement can be ignored if the continuous performance of three (3) months is credited at least in a peritoneal dialysis unit. The staff of nursing assistants should be assisted by nurses and/or nurses under their supervision.

(c) Infirmary staff who, at the time of application of this law, are eligible for pre-approval units without meeting the requirements set out in points (a) or (b), may continue in service provided that they credit -- in the trial and under the responsibility of the unit chief -- sufficient suitability for the performance of their duties; otherwise they must be applied to other tasks. In any case, the availability of a nurse or nursing assistant for every five (5) patients in simultaneous dialysis process will be required.

(d) Serologic research should be conducted for the detection of antigenic markers of the hepatitis B virus, all medical and cleaning personnel.

Negative personnel should be studied every three (3) months. In addition, this staff may be protected by active immunization with antihepatitis B vaccine.

IV - Instruction of Patients

(a) Patients in outpatient treatment with continuous outpatient peritoneal dialysis will be trained in the dialysis unit by a nephrologist of the unit or a nurse belonging to the unit, specially trained for this function.

(b) Clinical history of hepatitis B should be collected for dialysis patients. They should also be researched serologically for the detection of antigenic markers of the hepatitis B virus. Negative patients should be studied on a monthly basis and may be protected by active immunization with antihepatitis B vaccine. Positive patients to any antigenic marker or hepatitis B, or with a clinical history of hepatitis, should be dialed in a separate location for isolation.

Of the Aguda Renal Insufficiency

Patients with acute renal insufficiency requiring dialytic treatment should be preferentially dialed in an area other than that for the treatment of patients in chronic dialysis. Those patients who require only peritoneal dialysis may eventually be dialed outside the area of intensive care, if the treating doctor so has.

Enabling and Control

The national health authority, the provincial health authorities, the Municipality of the City of Buenos Aires and the National Territory of Tierra del Fuego, Antarctica and the South Atlantic Islands, will have an agency of their dependence responsible for the compliance with these regulations of empowerment and control. They should be part of this nephrotic medical organism with dialysis experience not less than two (2) years.

Advisory Council

The Enabling and Control Agency will have an Advisory Council consisting of five (5) members appointed by the corresponding health authority, each of whom must be the head of a dialysis unit authorized by the health authority or a nephretic doctor who has experience in dialysis not less than two (2) years. The Council shall advise the enabling and control agency in all matters relating to the medical and technical aspects of this law and shall, when it deems appropriate, propose modifications to its regulation that the advance of scientific knowledge make necessary.

Article 4 - Unregulated.

Article 5: The national health authority and the provincial health authorities, the Municipality of the City of Buenos Aires and the National Territory of Tierra del Fuego, Antarctica and the South Atlantic Islands shall provide that the agency responsible for the establishment of the dialysis units shall carry and maintain an updated record indicating:

(a) Number of patients in dialysis.

(b) Mortality.

(c) Causes and number of internships and average days of stay.

(d) Notification of cases of hepatitis B in accordance with Act No. 15,465 and Regulation Decree No. 2,771/79.

(e) Rehabilitation indices:

1. Trained to work and works full day.

2. Trained to work, but not working full day.

3. Trained to work, but unemployed.

4. Trained to work, but retired.

5. Incapacitated to work, but it's enough for itself.

6. Incapacitated to work. It's not enough for itself.

(f) Costs per patient.

(g) Total costs.

For this purpose, the authorized dialysis units shall transmit directly or through the establishments on which the information requested by such authorities depends.

Article 6.

Article 7 - Not regulated.

Article 8 - Not regulated.

Article 9 - Not regulated.

Article 10.

Article 11 - Not regulated.

Article 12 - Unregulated.

Article 13 - Not regulated.

Article 14 - Not regulated.

Article 15.

Article 16 - Unregulated.

Article 17 - Not regulated.

Article 18 - Not regulated.

Article 19 - Unregulated.

Article 20 Unregulated.