Question

1- Describe the recommendation of Doctor over Hepatitis B in adults

2- Enumerate 5 tests of laboratory of moderate-complexity

3- Briefly describe the concept of Laboratory of Moderate-Complexity and high-complexity Levels

Answer 1

1. Recommendations of Doctor over Hepatitis B in adults are:

The patient having this disease don't usually have symptoms especially in chronic condition. During acute condition it shows few symptoms like fever, poor diet etc., An adult having this disease should have regular checkup, do blood testing to know the condition of the disease for further treatment. If left untreated the chronic condition may lead to cirrhosis and also may lead to liver cancer these condition are difficult to treat. Maintenance of diet can help control this disease that is high intake of protein, less salt and water intake and reducing the consumption of non-vegetarian food. Regular diagnosis and medications can help in controlling this disease.

2. Tests of laboratory of moderate complexity :

Waived Testing : As defined by CLIA(clinical laboratory improvement amendments), waived tests are simple tests with a low risk for an incorrect result. They include:

• Certain tests tested in the CLIA regulations
• Test cleared by the FDA for home use
• Tests that the manufacturer applies to the FDA for waived status by providing scientific data that verifies that the CLIA waiver criteria have been met.

Nonwaived Testing: is the term used to refer collectively to moderate and high complexity testing. Laboratories or sites taht perform thess tests need to have a CLIA certification, be inspected, and must meet the CLIA quality standards.

3. Concept of laboratory of moderate complexity and high complexity :

Moderate complexity :

• More difficult to perform.
• Requires documentation of training.
• Test principles.
• Instrument calibration.
• Quality control.
• Proficiency testing required.
• On-site inspection required.
• Competency training required.

High Complexity

• Sophisticated instrumentation.
• High degree if interpretation by testing personnel.
• Formal education, with degree in laboratory medicine.
• Proficiency testing required.
• On-site inspection required.
• Competency testing required.