Review Questions 6-4

10) Discuss the importance of quality assessment in POCT programs

All control and standard results should be within the QA program as absence of records or incomplete records can indicate that the QA program is insufficient or not a priority

12) What is the primary law that regulates POCT

CLIA '88

9) Name four chemistry tests often performed at point of care

Cholesterol, Electrolytes, Blood glucose, Creatinine

4) What technological developments have made POCT possible

Instrument design has mushroomed. Today analyzers are available for hematology, analyses, urine chemistries, coagulation tests, blood chemistries, pregnancy test kits and immunology procedures. These can be used at hospital bedsides, IC Units, physician offices, medium sized laboratories

11) Why is it important for one department to be responsible for training all POCT technicians

It is best to have one to two training coordinators in a central laboratory to ensure that all employees are trained in the same manner. If a training is at remote sites and high employee turnover, there is a potential for training deficiencies. Supervisors should also have good communication skills and background in QA, they should be trained by manufacturer representatives so that they can troubleshoot problems appropriately. It is recommended to follow these procedures to eliminate a decline in the results quality

6) What are the requirements for a test to be CLIA waived

Laboratory test and procedure must be simple to perform and have an insignificant risk for an erroneous result

13) What safety precautions must be observed when performing POCT

OSHA and CDC safety guidelines and regulation are required. Written safety rules should encompass. Standard Precautions within a procedure manual and should be followed rigorously.

3) Name five departments that have decision-making responsibility or otherwise participate in POCT Programs

Table 6-5: a) Clinical laboratory b) Nursing c) Medical Staff d) Safety Officer

2) What are the four disadvantages of a POCT program

Table 6-6: a) Increase personnel Costs b) Duplication of costs for standards and controls c) Potential for insufficient personnel training d) Repeat tests require repeat capillary collection

8) Name two hematological tests often performed at point of care

Table 6-7: Hemoglobin, hematocrit

7) What documents must be on file for CLIA-waived tests

a) Compliance with regulatory agencies b) Safety program c) QA program d) Personnel training and assessment e) Technical support f) Data management

1) What are four advantages of a POCT program

a) Hopsital Point of Care Testing to provide rapid results to b) POCT tests such as Rapid test results give reproducible results, are easy to use and require little maintenance. They are also small and portable analyzers, regulated by the CMS c) Blood glucose monitors have been in existence at the height of POCT. They are able to give rapid glucose results to adjust insulin dosage, diet and activity levels d) Today analyzers are available for hematology, analyses, urine chemistries, coagulation tests, blood chemistries, pregnancy test kits and immunology procedures

5) How do hospital POCT programs differ from nonhospital programs

a) Hospital patients benefit from rapid test measurements such as bedside glucose analyzers, electrolytes in the emergency room, surgery, and blood clotting time in critical care (TAT Turn Around Time for laboratory results can affect patient immediate treatment) b) Non-Hospital Settings: Programs in nursing homes, blood donation centers, physician office laboratories, health fairs, physicial examination for employment & insurance. Rapid results are not critical to patient immediate care, but the on-site testing saves time and costs for the patient as well as the healthcare provider