Laboratory Services Classification Quiz

Study Notes

Laboratory Services and Regulations

Secondary laboratories offer a variety of services such as specialized testing, advanced diagnostics, and sample analysis not provided by primary labs.
COVID laboratories may be under the jurisdiction of the Department of Health (DOH) as part of their regulatory framework.

Enforcement and Penalties

The consequence of a 4th offense for clinical laboratories not operating under the OSSOLS licensing system can include severe fines or revocation of operating privileges.
Operating a Clinical Laboratory without the necessary DOH-PTC (Department of Health - Permit to Construct) and corresponding DOH-LTO (License to Operate) may result in substantial penalties including monetary fines and potential legal consequences.

Laboratory Service Limitations

Primary laboratories do not offer specialized diagnostic services, which are typically reserved for secondary and tertiary labs.

Sanctions Under OSSOLS Licensing System

For a 2nd offense under the OSSOLS licensing system, clinical laboratories may face sanctions such as temporary suspension or additional fines based on the severity of the violation.

Safety and Operational Standards

The minimum respirator efficiency required for COVID-19 labs is typically set at a high percentage to ensure adequate protection against airborne pathogens.
A Class II Biological Safety Cabinet is commonly used in COVID-19 laboratories to provide a sterile environment and protect both the samples and laboratory personnel.

Licensing and Operational Procedures

The renewal period for non-hospital based labs' License to Operate (LTO) is traditionally set at regular intervals, typically every three years depending on regulatory requirements.
Laboratories must maintain records for a minimum duration, often specified by regulations, which is usually at least five years.

Tertiary Laboratory Requirements

A tertiary laboratory must have a minimum working area that accommodates advanced equipment and personnel, typically designed to handle complex diagnostics and specialized testing.

Inspection Authority

The Department of Health or designated regulatory bodies are responsible for conducting announced inspections of laboratories to ensure compliance with established standards and regulations.

Description

Test your knowledge on the classification of laboratory services, including primary and secondary services, routine clinical chemistry, special chemistry, and microbiology procedures. Learn about the different types of tests and procedures offered in hospital-based laboratories.