Question

Can someone please answer the questions 1, 2, 4, and 5 of this sample case study? Thank you

Chapter 15: Compliance Issues-The Regulations 38 Case Compliance Issues-The Regulations Study You are a supervisory level, clinical laboratory scientist (10 years of experience) in a 300+ Bed,The Joint Commission (TJC) accredited hospital. The laboratory di- rector informs you that the organization's administrator has asked the laboratory to assess the institution's overall approach to meeting its regulatory responsibilities including point-of-care testing (POCT). In addition to the main laboratory test- ing, POCT is performed on inpatients, outpatients, at off-site clinics, and through outreach (e.g, visiting nurses). The laboratory director asks you to overall responsibility for this reevaluation. Issues and Questions to Consider: I. What regulations govern point-of care testing? 2. What type of quality control for point-of-care testing must be implemented? 3. What kind of complexity testing does point-of-care fall under? . What kind of tests does point-of-care testing offer? 5. What is the benefit of point-of-care testing? 6. Who is allowed to perform point-ofcare testing? What type of training is required?

Answer 1

1-To develop and successfully run a POCT program that meets the federally mandated standards evaluated by accrediting agencies with Health Care Financing Administration (HCFA) status, requires that participants are aware of CLIA '88 requirements. Joint Commission on Accreditation of Healthcare Organizations (JCAHO), College of American Pathologists (CAP) and Commission on Office Laboratory Accreditation (CQLA) are the 3 principal organizations currently inspecting and accrediting POCT programs. They have included all CLIA '88 requirements on their inspection checklists.

2-Developing an appropriate QC plan for POCT

Laboratory type instruments – full size instruments, for example blood gas analysers. Similar to instruments you might find in a laboratory, the QC procedures for these types of analysers should follow full laboratory QC protocol. Multi-level QC samples should be run on these instruments every day a patient test is performed and the accuracy and reliability of those results should be monitored over time by participating in a frequent PT scheme.

Cartridge-based instruments – for example HbA1c and INR analysers. These are usually very different from that found in a standard laboratory, consisting of a cartridge based component and an electronic reader, which may have a self-check system built in. The cartridge contains all the necessary components for the analysis of the patient sample.

Strip based instruments – for example electrochemical or reflectance strip based glucose meters. These are similar to cartridge based instruments in that the strips are responsible for the analysis of the sample. However, unlike cartridge devices the electronic component has no self-check feature and without this a faulty analyser could be producing erroneous results for some time undetected.

3-The Clinical Laboratory Improvement Amendments (CLIA) outlined in the Code of Federal Regulations (refer 42 CFR 493) provides a complexity system for laboratory tests based on seven criteria. Laboratory tests are first divided into waived and nonwaived. Nonwaived tests are further divided into moderate and high complexity. The test complexity is assigned by the FDA. This is done during the pre-market approval process. If the laboratory develops its own test or if an approved test is modified in any way from the manufacturer's operating instructions, the complexity category defaults to high complexity per the CLIA regulations.

CLIA-waived tests are defined as test systems that are easy to use or operate, with low risk for an incorrect result and, that if testing errors do occur, the risk of patient harm is low. This category includes tests provided on a list published by CLIA, tests cleared by the FDA for home use, and tests approved for waiver by the FDA using the CLIA criteria.

4-Of the two major categories the first is small handheld devices, providing qualitative or quantitative determination of an increasing range of analytes. The dominant technologies here are glucose biosensor strips and lateral flow strips using immobilised antibodies to determine a range of parameters including cardiac markers and infectious pathogens. The second category of devices are larger, often bench-top devices which are essentially laboratory instruments which have been reduced in both size and complexity. These include critical care analysers and, more recently, small haematology and immunology analysers. New emerging devices include those that are utilising molecular techniques such as PCR to provide infectious disease testing in a sufficiently small device to be used at the point of care.

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Point-of-care (POC) or with-patient testing allows physicians and medical staff to accurately achieve real-time, lab-quality diagnostic results within minutes rather than hours. Through the use of portable blood analyzers, testing at the “point of care” streamlines the diagnostic process and helps ensure patients receive the most effective and efficient care when and where it is needed.

POC testing enables staff to make rapid triage and treatment decisions when diagnosing a patient’s condition or monitoring a treatment response. By simplifying the testing process, clinicians can focus on what matters most—providing effective, quality patient care.

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