How to set up an analytical diagnostic laboratory-like quest diagnostic

Do you want to open the best diagnostic lab like the quest diagnostic? Now we bring you the general guidelines on how to set up an analytical diagnostic laboratory and what are the requirements for activity licenses, etc.

So, in this article you will know all the details of opening the diagnostic lab like the quest lab, you just have to read the complete article to know about it.

What is an analytical quest diagnostic laboratory?

An analytical quest diagnostic near me laboratory is that place where clinical analyzes are carried out on specimens and samples from the human body (regardless of the place where they are processed).

These samples contribute to the study, diagnosis, prognosis, treatment, and prevention of diseases, as well as the identification of any modification of the physiological state.

They may have one or more of the following services or units in their healthcare offer:

Clinical analysis: It is the unit in quest labs in which, under the responsibility of a physician specializing in clinical analysis, actions are carried out that – through analytical diagnostic tests, functional or laboratory tests and their pathophysiological correlation – help the diagnosis, prognosis, therapy medical and disease prevention.

Clinical biochemistry: It is the unit quest diagnostic lab in which, under the responsibility of a specialist in clinical biochemistry, the chemical and biochemical laboratory methods necessary for the prevention, diagnosis, prognosis, and evolution of the disease, as well as its response to the disease, are applied. treatment.

Immunology: It is the unit quest diagnostic near me lab in which, under the responsibility of a specialist in Immunology, is dedicated to obtaining the necessary information for the study, diagnosis, and treatment of patients with diseases caused by alterations of the immunological mechanisms and of the situations in which that immune manipulations are an important part of treatment or prevention.

Genetics: It is the unit in quest labs in which, under the responsibility of a doctor with adequate training, is dedicated to carrying out genetic tests and issuing the corresponding opinions for diagnostic purposes.

Hematology Laboratory: It is the unit in a quest diagnostic that, under the responsibility of a doctor specializing in hematology and hemotherapy, is dedicated to obtaining samples and specimens of human origin, carrying out hematological determinations, and issuing the corresponding opinions for diagnostic purposes.

Microbiology and parasitology: It is the unit in quest diagnostics near me lab that, under the responsibility of a specialist in microbiology and parasitology, is dedicated to the study of microorganisms related to the human species, focusing on the sick man or carrier of infectious diseases for diagnosis, epidemiological study, and therapeutic guidance.

Obtaining samples: It is the unit in quest labs that linked to a clinical laboratory, in which health personnel with adequate qualifications carry out the collection, reception, identification, preparation, and conservation of the specimens or biological samples of human origin, is responsible for the sample until it is delivered to the corresponding laboratory.

The work in the analytical diagnostic laboratory is structured around three main areas: sampling, analysis of samples, and transport of samples, and delivery of results.

It is important that you know that not all laboratories can perform any kind of study, as there are complex exams that require very expensive equipment. In this sense, two types of laboratories are distinguished:

Routine laboratories: these are those in quest diagnostic lab that have departments of hematology, immunology, microbiology and clinical chemistry, and biochemistry. These laboratories perform common tests such as hematic biometries (blood test), general urine test, glucose tests (in cases of diabetes), pregnancy tests, etc.

Specialty laboratories: These are those in quest diagnostics near me lab which more complex or sophisticated studies are carried out, such as genetic tests or hormone levels. These laboratories use methodologies such as nucleic acid amplification, flow cytometry, and high-resolution chromatography, which require specific facilities and equipment, as well as specially trained personnel. These labs are often part of research programs.

The analytical diagnostic centers must carry out most of their activities in their own facilities, although they can formalize contracts or collaboration agreements with other authorized centers, in which case they must be communicated to the General Directorate of Organization and Inspection of the Ministry of Health of the Community.

Technical conditions of an analytical diagnosis laboratory:

As established in Order 2096/2006, of November 30, 2006, every analytical diagnosis center-like quest labs will have a room with the minimum distribution and surface area that allow the proper development of the activity. 

At least you will have the following areas:

  1. Administrative area
  2. Patient care area and reception of samples and specimens
  3. Waiting room, with a surface that guarantees the adequate stay of patients
  4. Room for taking samples and specimens, in which it is possible to guarantee the confidentiality and comfort of the patient.
  5. Laboratory room itself, which will have a sufficient surface to develop the different techniques, as well as specific areas in accordance with biosafety standards (culture media preparation area; material washing and sterilization area; example).
  6. Toilet services.

The centers in which no samples are obtained or extractions are carried out, by limiting their activity to the analysis of the material received, are not obliged to comply with the requirements of points c) and d).

The sample collection units may be located in the same laboratory or outside of it, in which case they must be related to a duly authorized analytical diagnostic center, which will be the one that makes the appropriate analytical determinations.

In any case, a plaque or external identification will be placed indicating: the authorized analytical diagnosis center on which it depends, the technical director of the same, and its status as a sample collection unit.

The diagnostic center like quest diagnostics near me lab will have adequate light and rigid containers, as well as essential disposable material for taking samples and specimens. 

In the event that extractions are carried out, you will also have a suitable stretcher and/or chair. In addition, the premises must be suitable for your activity, so they must meet the following requirements:

  • Walls and floors that are easy to wash and/or disinfect and free from humidity.
  • Adequate lighting, ventilation, and conditioned temperature.
  • Emergency lighting, especially in public areas.
  • Fire extinguishers in adequate numbers for the premises, which comply with the applicable legislation on fire prevention and are guaranteed and updated by the competent authority or body.

Requirements for the operation of an analytical diagnostic laboratory Care offer:

Every analytical diagnostic center like the quest diagnostics near me lab must have a list with all the different tests that are carried out in the center, the techniques used for each one, and the estimated response time, as well as those that are sent to other centers, with their specification.

Procedures manual:

The procedures manual will always contain updated, at least, the following procedures:

Procedure for obtaining the different types of samples and specimens, with an indication of the preservatives, anticoagulants, or other additives to be used if necessary, as well as a description of the handling, transport conditions of those and the prior preparation that the patient.

Working procedures in which the methods and protocols that are being used are detailed, with their basis, the description of the preparation of reagents or media, the performance of the techniques, the measurement methods, and the necessary instruments.

Procedure-related to the treatment and protection of the data, the filing system and the updated manual of the computer system, protection systems of the same and backup copies; as well as a security document for staff with access to personal data. 

This document must establish the measures, standards, and procedures aimed at guaranteeing the level of security required in current regulations, with special reference to the measures required at the high level of protection. In this sense, you must thoroughly know the Law on Protection of Personal Data to avoid eventual sanctions.

-Safety regulations and recommendations of professional societies for patients, workers, environment, reagents, waste, and emergencies. 

You should know that the safety manual must be updated before any extension or modification of the activity and objective of the laboratory, as well as the new technologies that can be incorporated.

Administrative authorizations, registrations, and licenses prior to the start of the activity:

You should know that, according to the General Health Law 14/1986, it is established that health centers, services, and establishments, whatever their level, category, or owner, will require administrative authorization prior to its installation and operation.

Installation authorization: 

This authorization will be required in the event that the laboratory you want to set up involves the realization of new work and/or in the event that you want to make modifications that involve substantial or significant alterations in its structure or facilities.

Obtaining this installation authorization does not entitle you to open and operate the laboratory. This will only happen after the request and subsequent granting of the operating authorization.

To request the installation authorization, you must present the following documentation (originals or certified photocopies) along with the official application form:

– Document justifying the payment of the amount of the fees. The document can be obtained at the Auxiliary Registry of the Ministry of Health.

– Document accrediting the applicant’s personality. If the holder is a natural person, the applicant’s DNI / NIF will be presented. If an owner is a legal person, the company’s CIF, articles of incorporation (which include the company’s statutes) and the DNI / NIF, and accreditation of the legal representative will be presented.

– Document proving the ownership of the legal availability of the property in which the laboratory will be located. For this, the deed of sale or the lease will be presented.

– Explanatory health report of the nature and purposes of the center, signed by the health director or responsible, stating: the portfolio of services or list of specialties of the center; health activity, techniques, diagnostic tests, etc. of each of the specialties; the schedules of attention to the public, specifying dates and times of each activity; if surgical and/or radio diagnosis activity is performed; whether or not it is a producer of bio sanitary waste.

– Forecasts for health professionals who will provide services at the center, whatever their legal relationship will be, broken down by professional categories and, where appropriate, with the determination of their functional assignment. It is not necessary to specify the name and surname of the professionals.

– Technical project, including the work management certificate, signed by a competent technician and endorsed by the corresponding Professional Association 

List of sanitary equipment and/or apparatus:

If the documentation presented is incomplete or does not meet the established requirements, the interested party will be required to correct the lack within 10 days or submit the mandatory documents, with the indication that if he does not do so, he will be considered as withdrawn. of your request. 

Once the deficiencies have been corrected, an inspection visit may be made to the health center, service or establishment, to check the technical health requirements and their adequacy to the submitted application, drawing up, where appropriate, the corresponding report.

In view of this and/or the documents provided, the deficiencies detected will be notified, where appropriate, and a new deadline may be established for their correction. 

From that moment, and within a period of 2 months, the notification of the concession or denial of the installation authorization will be produced.

Operation authorization:

Once the installation authorization has been granted, you can request the operation authorization, which is what will empower you to start your activity, being mandatory prior to the start of it. To do this, you must present the following documentation (originals or certified photocopies) along with the official application form:

– Document justifying the payment of the amount of the fees. The document can be obtained in the Auxiliary Register of the Ministry of Health.

– Definitive staff of health professionals who provide services in the center, service, or establishment, signed by the technical director, whatever their legal relationship will be, broken down by professional categories and where appropriate, with the determination of their functional assignment.

– Academic qualifications of the professionals, as well as a certificate of membership issued by the corresponding Professional Association, and professional civil liability insurance for each of the health professionals who carry out their professional activity in the center, service, or establishment. A valid policy and receipt will be presented.

– Policy and current receipt of the center’s container and content insurance.

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