INSTITUTE FOR STANDARDIZATION OF CLINICAL LABORATORIES OF PERU
- What is a clinical laboratory
- Steps to implement your clinical laboratory
- Distribution environment
- Infrastructure and equipment
- Types of analyzers for clinical laboratories
- Implementation of MoD and JPES documents
- Staffing requirements
- Labels that the laboratory must have
- Steps for the process of starting an activity
- Application to SUSALUD
CLINICAL LABORATORY
A laboratory for biological, microbiological, immunological, chemical, immunohematological, hematological, biophysical, cytological, pathological, genetic or other analysis of materials obtained from the human body, for the purpose of providing information for the diagnosis, management, prevention and treatment of diseases in humans or the assessment of their health and can provide advisory services covering all aspects of laboratory investigations, including interpretation of results and advice on appropriate further testing.
Reference: ISO 15189
A laboratory for biological, microbiological, immunological, chemical, immunohematological, hematological, biophysical, cytological, pathological, genetic or other analysis of materials obtained from the human body, for the purpose of providing information for the diagnosis, management, prevention and treatment of diseases in humans or the assessment of their health and can provide advisory services covering all aspects of laboratory investigations, including interpretation of results and advice on appropriate further testing.
Reference: ISO 15189
There are two types of clinical laboratories, according to their functions:
1. Routine laboratories: These laboratories basically consist of four departments:
1. Routine laboratories: These laboratories basically consist of four departments:
- Hematology
- Immunology
- Microbiology
- Biochemistry
- umbilical cord
- stem cells
- histocompatibility
- cytogenetics
- molecular biology
- the rest
CONCLUSIONS:
A clinical laboratory can have different areas that are defined in the business model.
Not every area of the clinical laboratory is implemented in the same way;
The requirements for each area are based on biological safety standards and the complexity of operational processes.
The business model will allow us to know what requirements we have to meet to implement each area.
A clinical laboratory can have different areas that are defined in the business model.
Not every area of the clinical laboratory is implemented in the same way;
The requirements for each area are based on biological safety standards and the complexity of operational processes.
The business model will allow us to know what requirements we have to meet to implement each area.
STEPS FOR CLINICAL LABORATORY IMPLEMENTATION:
- INFRASTRUCTURE
- EQUIPMENT
- STAFF
- DOCUMENTATION
There are two options for setting up a clinical laboratory:
1. Inside the health care facility Clinical laboratory
2. It functions only as a Clinical laboratory
1. Inside the health care facility Clinical laboratory
2. It functions only as a Clinical laboratory
LEGAL REGULATION and QUALIFICATION OF ENTITIES
CATEGORIZATION
clinical laboratory areas
clinical laboratory aereas
INSTITUTIONS PROVIDING HEALTH SERVICES IN CLINICAL WORK IPRESS
There are two options for setting up a clinical laboratory:
1. Inside the health care facility Clinical laboratory
2. It functions only as a Clinical laboratory
1. Inside the health care facility Clinical laboratory
2. It functions only as a Clinical laboratory
Health institution:
1. In a health care facility:
3. Work with other SMA (for example, clinical laboratory plus x-rays) (As external or EESS laboratory service)
CATEGORIZATION PROCESS (DIRIS, DIRESA, GERESA)
1. In a health care facility:
- Polyclinic
- Clinic
- "Medical Support Service" SMA
3. Work with other SMA (for example, clinical laboratory plus x-rays) (As external or EESS laboratory service)
CATEGORIZATION PROCESS (DIRIS, DIRESA, GERESA)
CATEGORIZATION PROCEDURE
A process that leads to the homogenization and classification of various health care institutions and medical support services, based on levels of complexity and functional characteristics, which enable it to respond to the health needs of the population it serves.
A process that leads to the homogenization and classification of various health care institutions and medical support services, based on levels of complexity and functional characteristics, which enable it to respond to the health needs of the population it serves.
CATEGORIZATION PROCEDURE
- Does it have adequate infrastructure?
- Do you have the equipment to provide patient care?
- Does it have adequate staff according to the portfolio of services it will offer to the population?
- Do you have management and technical documents that enable you to provide quality care?
- Does it comply with the regulations related to the rights of users of health services?
CLINIC
- The categorization of IPRESS is according to RM N° 546-2011/MINSA NTS Nº 021-MINSA/DGSP-V.03, this ministerial resolution describes which health institutions can have a clinical laboratory.
- In Peru, health facilities are categorized according to three levels of care according to ministerial resolution no. 5462011/MINSA NTS no. 021-MINSA/dgsp-v.03 according to the technical health standard "Category of health institutions in the health sector", which basically refers to the determination of its ability to resolve, responding to similar socio-sanitary realities and designed to face the health requirements of the population.
STRUCTURE
ORGANIZATION
DESIGNING
- A project is the planning and execution of a series of actions that are carried out with the aim of achieving a certain goal.
Project life cycle:
- Beginning
- Planning
- Execution
- Monitoring and control
- Closure
LEGAL START
This phase includes the first procedure that must be carried out in the municipality:
• Go to the district or provincial municipality and ask for a certificate of compatibility of use.
Compatibility of use must mean:
• The activity of the CLINICAL LABORATORY is compatible with the zoning of the district.
• If it is NOT compatible, you will not be able to proceed with the project.
This phase includes the first procedure that must be carried out in the municipality:
• Go to the district or provincial municipality and ask for a certificate of compatibility of use.
Compatibility of use must mean:
• The activity of the CLINICAL LABORATORY is compatible with the zoning of the district.
• If it is NOT compatible, you will not be able to proceed with the project.
LEGAL REGULATION
• It must have a space of at least 90 square meters
(the area depends on the portfolio of services and equipment).
• Preferred location must be on the avenue and on site
which is compatible with business according to
local municipality.
• Before renting, buying or building, you need to find out if it can
clinical laboratory to work at that location, in accordance with Urbanism
the development plan of your place.
• It must have a space of at least 90 square meters
(the area depends on the portfolio of services and equipment).
• Preferred location must be on the avenue and on site
which is compatible with business according to
local municipality.
• Before renting, buying or building, you need to find out if it can
clinical laboratory to work at that location, in accordance with Urbanism
the development plan of your place.
This phase includes the first procedure that must be carried out in the municipality:
• Go to the district or provincial municipality and ask for a certificate of compatibility of use.
Compatibility of use must mean:
• The activity of the CLINICAL LABORATORY is compatible with the zoning of the district.
• If it is NOT compatible, you will not be able to proceed with the project.
• Go to the district or provincial municipality and ask for a certificate of compatibility of use.
Compatibility of use must mean:
• The activity of the CLINICAL LABORATORY is compatible with the zoning of the district.
• If it is NOT compatible, you will not be able to proceed with the project.
Laboratory and office spaces
Laboratory facilities and associated offices must provide an appropriate environment for the performance of tasks, in order to ensure that the following conditions are met:
a) Access to areas that affect the quality of analyzes is controlled.
b) Clinical information, patient samples and laboratory resources are protected from unauthorized access.
AUTHORIZED PERSONS ONLY
c) Adequate facilities enable the correct performance of the analysis.
Conditions that must be controlled include, for example:
size and complexity of the facility to ensure efficient transfer
information.
Laboratory facilities and associated offices must provide an appropriate environment for the performance of tasks, in order to ensure that the following conditions are met:
a) Access to areas that affect the quality of analyzes is controlled.
b) Clinical information, patient samples and laboratory resources are protected from unauthorized access.
AUTHORIZED PERSONS ONLY
c) Adequate facilities enable the correct performance of the analysis.
Conditions that must be controlled include, for example:
- energy sources
- lighting
- ventilation
- noise control
- water
- waste disposal
- environmental conditions.
size and complexity of the facility to ensure efficient transfer
information.
Storage facilities
- Storage conditions and space must be such as to ensure the permanent integrity of the sample, documents, equipment, reagents, consumables, records, results and all other items that could affect the quality of the analysis results.
- Clinical specimens and materials used in testing procedures should be stored in a manner that prevents cross-contamination.
- Facilities for the storage and disposal of hazardous materials must be commensurate with their risks, as determined by applicable requirements.
Facilities for staff:
- Adequate access to toilets, drinking water supply and storage areas for personal protective equipment and clothing should be provided.
Facilities for patient sampling:
- Patient specimen collection facilities should have a separate reception/waiting room and specimen collection areas.
- Sample collection facilities must have and maintain adequate first aid supplies for patients and staff.
- During sample collection, the privacy, comfort and needs of the patient (e.g. access to disabled people, health services) and their companion (e.g. guardian or translator) should be taken into account.
- Institutions where sampling procedures (e.g. phlebotomy) are carried out must enable sampling to be carried out in a way that does not invalidate the results or negatively affect the quality of the analyses.
MAINTENANCE
- Maintenance of facilities and environmental conditions:
- Laboratory equipment must be maintained in a functional and reliable condition.
- Work areas must be clean and well maintained.
- The laboratory must monitor, control and record environmental conditions, as required by relevant specifications or when they may affect sample quality, results and/or personnel health.
CONCLUSIONS:
- Defining the categorization that is needed.
- Start the procedure with the municipality before any construction or renting of space.
- Depending on the offer and level of automation, define the room dimensions and floor plan.
