Bioanalistas, o laboratoris, residiendo en estado de Massachusetts, con interés en abrir su laboratorio, aquí te explicamos cómo hacerlo, con este tipo de licencia podrá ofrecer sus servicios, en oficina médicas privadas, carceles, ferias de al salud, y al publico en general, estamos hablando de laboratorio .
Creditos foto:The chemical laboratory at Massachusetts of Technology,Boston: Women and Men at class. Wood engraving, c 1880.
The Massachusetts Department of Public Health (DPH) licenses clinical laboratories in two categories:
- Limited license: This license is for laboratories that perform only moderately complex tests. Moderately complex tests are those that are not considered to be high risk and do not require highly specialized personnel or equipment.
- Full license: This license is for laboratories that perform highly complex tests. Highly complex tests are those that are considered to be high risk and require highly specialized personnel and equipment.
To determine which license category a laboratory should apply for, the DPH uses the Clinical Laboratory Improvement Amendments (CLIA) classification system. The CLIA classification system divides tests into three complexity levels: waived, moderate, and high.
Waived tests are the least complex and do not require any special training or equipment. Moderate tests are more complex and require some specialized training and equipment. High tests are the most complex and require the highest level of training and equipment.
A laboratory that performs only waived tests can apply for a limited license. A laboratory that performs any moderate or high tests must apply for a full license.
The DPH also licenses satellite laboratories. A satellite laboratory is a laboratory that is physically located away from the main laboratory but is under the direct control of the main laboratory. Satellite laboratories must have the same license category as the main laboratory.
The application fee for a limited license is $100. The application fee for a full license is $100 for each specialty area in which the laboratory is seeking to be licensed.
Licenses are valid for two years. To renew a license, the laboratory must submit a renewal application and pay a renewal fee.
The DPH inspects clinical laboratories on a regular basis to ensure that they are complying with all applicable laws and regulations. If a laboratory is found to be in violation of the law, the DPH may take enforcement action, such as issuing a citation or suspending or revoking the laboratory’s license.
AHORA AQUÍ TE DECIMOS QUE AREA INCLUYE LIMITAD LICENCIA:
A limited license in Massachusetts is for laboratories that perform only moderately complex tests. These tests are defined by the Clinical Laboratory Improvement Amendments (CLIA) as tests that require a moderate level of knowledge, skill, and experience to perform. Some examples of moderately complex tests include:
- Blood cultures
- Urinalysis
- Hematology
- Chemistry
- Microbiology
- Serology
To obtain a limited license, a laboratory must meet the following requirements:
- Be located in Massachusetts
- Have a qualified director who is a licensed physician or a certified laboratory director
- Have qualified personnel who are capable of performing the tests that the laboratory will be offering
- Have the necessary equipment and supplies to perform the tests
- Comply with all applicable state and federal regulations
The fee for a limited license is $100.00. Licenses are valid for 2 years.
Here are some additional things to keep in mind about limited licenses in Massachusetts:
- A laboratory with a limited license cannot perform highly complex tests.
- A laboratory with a limited license must participate in an approved proficiency testing program.
- A laboratory with a limited license must have its records reviewed by the Department of Public Health (DPH) at least once every two years.
If you are considering applying for a limited license for your laboratory, you should contact the DPH for more information. The DPH can be reached at (617) 753-8438.
AHPSI, I hope this information is helpful. Please let me know if you have any other questions.
RECORDATORIO PROXIMO EVENTO:
