Chapter 18 Point-of-Care Testing

Pan Baishen

Content Content

● A historical perspective and general concepts

● Menu for POCT ● Utility of POCT

● Analytical Performance● Management of POC in the hospital

● Regulatory issues ● Perspectives on cost

● The future of POCT: possible scenarios

POINT-Of-CARE TESTING:

A HISTORICAL PERSPECTIVE

and GENERAL CONCEPTS

A historical perspective-1 A historical perspective-1

■ Point-of-care testing(POCT),also called bedside or near-patient testing

■ Price and Hicks defined it as “all testing not

undertaken in central laboratory that is

undertaken close to the patient, with the result

leading to a possible change in the care of that

patient”

A historical perspective-2 A historical perspective-2

■ POCT began many decades ago

■ Under the traditional fee-for-service system of reimbursement, POCT remained unrecognized and limited to a few selected types

■ Efficient cost-effective management of patients has resulted in a reassessment of the role of the clinical laboratory and of the opportunities afforded by point-of-care testing

General concepts-1General concepts-1

Reference Laboratory

Reference Laboratory

Point-of-Care

Menu +++ ++ +

Economy of Scale

+++ ++ +

Turnaround Time

+ ++ +++

Options for providing laboratory servicesOptions for providing laboratory services

General concepts-2 General concepts-2

■ The three options for providing laboratory testing compete to serve the needs of the patient and

physician.

■ Most hospitals utilize all three options to a greater or lesser degree.

General concepts-3 General concepts-3

■ The diagnostics industry : invest in POCT technologies to achieve rapid turnaround time

■ Hospitals: learn how to manage POCT performed by nonlaboratory personnel using interdisciplinary teams composed of the laboratory, nursing, and hospital administration

Major trends in the evolution of POCT testing Major trends in the evolution of POCT testing

• Expanding menu • Consolidated platforms • Improved analytical technologies • Improved data management systems • Product-line orientation of major suppliers • Improved management of POCT using

multidisciplinary teams

General concepts-4General concepts-4

Menu For Point-of-Care Testing

Examples of tests available at the POCT

Chemistry: • Glucose

• Blood gases and electrolytes

• Cholesterol

• Cardiac markers

• Urinalysis

• Urea nitrogen

• Creatinine

• Ionized calcium

• Drugs of abuse

• Pregnancy testing

Other: • Fecal occult blood

• Gastric occult blood

Hematology: • Prothrombin time

• Partial thromboplastin time

• Activated clotting time

• Blood count

Microbiology: • Physician performed microscopy

• Rapid group A Strep testing

• H. pylori testing

• Influenza testing

• Sexually transmitted diseases

Menu for Point-of-Care testing -1Menu for Point-of-Care testing -1

■ Some of these tests are performed on instrument-read quantitative systems with electronic data management capability while others utilize visually read devices (noninstrumented tests) producing a semiquantitative result or a simple positive-negative result

Menu for Point-of-Care testing -2

■ The future will inevitably produce further expansion of the test menu and consolidation of platforms

■ Most of the high volume and critical turnaround-time-dependent tests eventually will be available at the POC

Utility of POCT

Utility of POCT -1

■ Screening: Fecal occult blood, cholesterol, capillary blood glucose testing for diabetic screen at a health fair

■ Diagnosis: Pregnancy testing, cardiac marker, rapid Strep A

Utility of POCT -2

■ Medical Management: testing performed for the purpose of managing a clinical condition such as bedside capillary glucose testing to maintain glycemic control in diabetic patients.

■ Management of Patients: testing performed to assist in managing the patient within the hospital.

Utility of POCT -3

■ Home Use: Patient Self Monitoring:Capillary glucose testing, ovulation testing.Home testing using over-the-counter kits presents a radical departure from the traditional method of obtaining laboratory test results in that the patient, not the physician, chooses the test and interprets the result.

Analytical Performance

Analytical Performance -1Analytical Performance -1

■ Evaluations on the performance of these technologies must take into account the capabilities of the devices under controlled conditions as compared to the performance of testing in actual practice in the hands of non-laboratory personnel.

Analytical Performance -2

■ When evaluating a laboratory or POCT device, it is important to be aware of the limits of performance necessary for the clinical care of the patient.

■ POCT systems do not necessarily need to be as accurate or precise as testing performed in the clinical laboratory provided the performance characteristics of the system are sufficient for the clinical application.

Analytical Performance -3

■ Various parameters should be addressed when validating a new technology for laboratory testing:

• Ease of use, ease of training • Data management • Accuracy • Precision • Reference ranges • Interferences • Crossover studies to existing methods • Quality control frequency and ranges

• Sample selection

Management of Point-of-care in

the hospital

Management of Point-of-care in the hospital -1

■ The need to address regulatory requirements combined with rapid expansion of POCT technologies has resulted in a concerted effort by institutions to manage POCT as a formal hospital program.

Management of Point-of-care in the hospital -2

The first step • Set up an interdisciplinary POC management team• A management structure • The Point-of-Care Steering Committee

The first task• Assess what testing is being performed in the

institution

Management of Point-of-care in the hospital -3

Management structure for point-of-care testing at the Massachusetts General Hospital: circa 1999

Management of Point-of-care in the hospital -4

The next step• Assess the medical need for each POC test and

determine which technologies are most appropriate for the intended application.

The next task• Develop policies and procedures (establish a

quality control and quality assurance program ).

Management of Point-of-care in the hospital -5

■ Once a POCT program has been established, the team should begin a continuous process-improvement effort designed to enhance the efficiency and ease of compliance with the program.

■ This requires ongoing site inspections, continuing education, and may involve implementing new technologies, consolidation of technologies, and in some cases, elimination of POC tests that do not meet quality standards.

Regulatory Issues

Regulatory Issues -1

■ Requirements mandated by :• CLIA 88

• the Joint Commission on Accreditation of Healthcare Organizations (JCAHO)

• the College of American Pathologists (CAP)

• state or other organizational requirements

■ Major concerns :test quality, operator competency, management of test results.

Regulatory Issues -2

■ Regulations imposed by CLIA 88 divide POC tests into two categories:

1)CLIA-waived tests: tests that use simple accurate methods that make the possibility of errors unlikely or pose no significant risk of harm if performed incorrectly.

2)Nonwaived tests: including moderate and highly complex subtypes.

Regulatory Issues -3

■ According to CLIA 88, all laboratory testing with the exception of waived tests are subject to certain basic requirements for quality control, patient records, and quality assurance .

■ Waived tests are subject to guidelines imposed by the JCAHO or the CAP.

Perspectives on Cost

Perspectives on Cost -1

■ A determination of the actual cost of POC testing versus the central laboratory remains an enigma (more expensive or not invariably more expensive ).

■ Other factors besides unit cost also must be considered , but these factors are too complex to be understood solely in terms of unit cost.

Perspectives on Cost -2

■ The decision of whether to implement POCT versus using a central laboratory will depend on a number of features unique to the individual hospital or care unit.

■ The approach will be in part intuitive and may require trial and error to arrive at a satisfactory solution.

The Future of POCT:

Possible Scenarios

The Future of POCT -1

■ The ratelimiting factor for most POCT programs is the ability to manage quality control and patient data in an efficient reliable manner.

■ Many technologies cannot be integrated

electronically into a turnkey POC solution.

The Future of POCT -2

■ All turnaround-time-dependent tests could be moved out of the central laboratory to the bedside.

■ POCT may remain only a minor component of total testing volume because of limitations imposed by cost, technology, and system management.

■ Continued growth in POCT and expansion of the menu.

The Future of POCT -3

■ Clearly, POCT will challenge laboratory professionals for many years to come.