POINT OF CARE TESTING  nursing homes

 blood drives
INTRODUCTION: DEFINITION OF POCT  Depending on the type of testing, the clinical setting, and the test
categorization (mandated bythe Clinical Laboratory Improvement Act,
Point of Care Testing or CLIA), testing may be performed by the following:
 laboratory testing that is performed outside the central or core  Nurses
laboratory and generally at the site of clinical care or close to the  Medical assistants
patient  Physicians
 performed by clinical staff rather than laboratorians in most settings  Office assistants
 performed by the patient at home
 home glucose monitoring for diabetics
 home coagulation testing for people on warfarin LABORATORY REQUIREMENTS
 Because POCT is mainly performed by nonlaboratorians, there are many
Regulatory Requirements
challenges to ensuring that testing is performed in an appropriate and
 The Clinical Laboratory Improvement Act of 1988 (CLIA 88) set basic
accurate manner
standards for laboratories to follow to ensure the accuracy of
 Regulatory requirements are available to help guide outpatient
patient test results regardless of the setting in which they are
locations in the implementation and maintenance of important
performed (Code of Federal Regulations, Part 493)
components of POCT
 These standards apply to central or core laboratories
 device manufacturers have built-in features to reduce the possibility of
performing testing on samples received from inpatient and
errors including:
outpatient locations
 passwords for individual users with lock-out if training is not up-
 They also apply to any other site performing testing,
to-date
including POCT and provider-performed microscopy
 requirements for external and internal quality control prior to
procedures (PPMP)
patient testing
 CLIA defines FOUR categories of test based on the following factors:
 electronic transmission of results
 level of training and education required to perform the test
 Some of the clinical settings where POCT is performed:
 reliability and stability of the reagents
 emergency rooms or urgent care settings, where often quick
 complexity of operational steps
decisions need to be made
 availability and stability of quality control and proficiency
 inpatient settings to maintain tight glucose control; physicians’
testing materials
offices
 requirements for maintenance of the test system
 health fairs
 level of judgment and interpretation required to perform
 cancer centers that perform infusions
the test and compile the results
 radiology sites prior to contrast administration
 presurgical testing
 Level of Complexity
(1) waived testing
Laboratory Dictatorship
- is testing that requires minimal training and education
to perform and/or would theoretically cause minimal
harm if the results were not accurate
- any test approved for home use
(2) provider-performed microscopy (PPMP)
- a discrete set of tests in which specimens that are time-
dependent are examined under a microscope at the
point of care
- can only be performed by licensed professionals as well
as nurse practitioners and physician assistants under
the direction of a physician, depending on the state in
which they practice
(3) moderate-complexity & (4) high-complexity testing
- performed in larger and more advanced laboratory
settings, including hospital and reference laboratories
LABORATORY DICTATORSHIP
 Laboratories that perform under a Certificate of Waiver or with a
certificate for PPMP can perform waived testing without the
overhead of having personnel who meet established qualifications
in training, experience, job performance, and competency
 If any moderate-complexity tests or measurements are performed,
CLIA requires that the laboratory be directed by a laboratory
director and/or a laboratory consultant with appropriate credentials
 Laboratory Director
 responsible for determining the qualifications of individuals
performing and reporting test results, as well as ensuring
compliance with all applicable regulations
 responsible for the analytic performance of all assays and
must monitor ongoing proficiency, accuracy, and precision
 If more than one individual in the practice qualifies as a
laboratory director, the laboratory is required to designate
one as being responsible.
 “ROUGE TESTING”
 Occurs when a clinic or service sets up a test without the
knowledge and supervision of the laboratory director
 Inspectors do not tolerate
 If an inspector finds a lab result and traces it back to a
laboratory that is not adequately supervised by the
laboratory director, a citation may be issued to the discredit
of the health care facility
CONNECTIVITY AND MANAGEMENT

Connectivity and Management

 Test results must be recorded in the patient’s chart, whether
electronic or on paper, and appropriate units of measure and
reference ranges must be included with the report
 Other data that must be maintained by the site are records of
validation of devices; validation and tracking of new lots of reagent;
quality control data, including proficiency testing results that must
be performed; all testing personnel; and operator training and
competency
IMPLEMENTATION OF POCT PROGRAM
Implementation of POCT program
 PHYSICIAN’S OFFICE
 POCT programs differ significantly, depending on the scope
of testing and the setting where it will be performed
 A physician or the medical director for the practice will
generally serve as the director on the Certificate of Waiver
 It will be his or her responsibility to develop policies and
procedures and lead the practice in deciding what testing to
perform and what methods to use
 HOSPITALS AND MEDICAL CENTERS
 A first step in implementing a POCT program at a hospital or
medical center is to establish a Point-of-Care Committee
 This committee should consist of representatives from the
clinical laboratory, particularly the medical director
responsible for POCT, the point-of-care manager and/or
administrator from the medical laboratory, and medical
staff from departments who frequently use POCT
 Point-of-Care Coagulation
 most common POC coagulation test is activated clotting
time (ACT)
 The first POC clotting times were performed by drawing
fresh whole blood, then periodically manually mixing or
inverting the tube and visually observing for clot formation.
 Point-of-Care Hematology
 the spun hematocrit was the most common POC
hematology test
 generally limited to hemoglobin and hematocrit on a blood
gas or chemistry device and prothrombin time and INR
formonitoring patients on warfarin

POINT OF CARE APPLICATIONS

Point-of-care Applications
 Point-of-Care Glucose
 Highest-volume POC test
 Frequently used to monitor the glucose level for patients
with diabetes, but it may be used for other purposes
 Point-of-Care Chemistry and Blood Gas
 Most operate on the principle of measuring potentiometric,
amperometric, or conductometric changes via sensors
(electrodes)
 Point-of-Care Connectivity
 the most significant recent development in POCT めい