Transcript Document 7532074

MOUNT AUBURN HOSPITAL
The Joint Commission
Chapter update: Waived Testing
September 22, 2010
What is Point of Care
Point-of-Care Testing (POCT) is defined as diagnostic testing at or
near the site of patient care. This testing is categorized as waived and
non waived testing.
Waived testing at Mount Auburn Hospital includes Glucose meters,
Fecal Occult Blood, Urine dipstick, and Urine hCG.
Non Waived testing at Mount Auburn Hospital includes Activated
Clotting Times (ACT) and Oxyhemoglobin. Non Waived tests are
more complex and cannot be performed by the consumer.
MOUNT AUBURN HOSPITAL
UNIT
Needham 8
Needham 7
Needham 3
South 5
Nursery II
L&D
South 4
South 3
Stanton 3
SDU/ Stanton 6
CCPM
CCPS
WIC
ED
Heme/Onc
GI Unit
Wyman 2
Radiology
PACU
Day Surg
Cath Lab
OR
Stanton 5
Stool
Occ Bld
POINT-OF-CARE TESTING
Urine Dipsticks
Urine
Pregnancy
Test
pH/Nitrazine
Testing
Bedside Glucose
Testing
AVOXimeter
Oxyhgb
ACT
Regulatory
All Point of Care tests are subject to regulatory guidelines.
• The College of American Pathologists (CAP) regulates
both Waived and Non Waived Testing
• The Joint Commission regulates Waived Testing
Bedside Glucose Volumes 2009
Patient Testing
78,468
Five “Elements of Performance”
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WT.01.01.01
WT.02.01.01
WT.03.01.01
WT.04.01.01
WT.05.01.01
Policies and Procedures
Testing and Supervising Staff
Competency
Quality Control
Documentation
Standard WT.01.01.01
The Director named on the CLIA certificate approves a
constant approach for when waived test results can be
used for diagnosis and treatment and when follow up
treatment is required.
• All procedures and policies are approved by the Director.
• Procedures and policies establish: usage and limitations,
need for confirmatory testing, specimen type collection
and identification/labeling and preservation, storage
conditions for test components, reagent use (expiration),
Quality control (frequency and type and remedial action)
result reporting and equipment performance
Standard WT.01.01.01 (cont.)
•Current and complete policies and procedures are available to
testing staff.
•Criteria for confirmatory testing is established and the use of
results is consistent with the hospital’s policies and the
manufacturers' recommendations for waived testing.
Standard WT.02.01.01
The Director identifies staff responsible for performing
and supervising waived testing
• Responsible staff may be employees of the hospital,
contracted staff, or employees of a contracted service.
• Responsible staff may be identified within job
descriptions, or by individual names.
• At Mount Auburn Hospital, the Director designates the
Laboratory’s POC Technical Coordinator to monitor the
testing and QC processes, according to regulatory
standards.
Standard WT.03.01.01
Staff and licensed independent practitioners performing
waived tests are competent.
Training for POC testing is done at hospital orientation and/or
on the Nursing Units, depending on the test. All training is
documented.
Competency assessment must include at least 2 methods of
review and these may include performance of blind specimens
(proficiency samples), direct observation of routine work, QC
monitoring, and written testing. Competency is assessed
initially and annually at a minimum.
Standard WT04.01.01
The organization performs quality control checks for
waived testing on each procedure.
• Procedures establish written Quality Control Plans for
each test based on: how the test is used, reagent stability,
manufacturers’ recommendation, the hospitals experience
with the test, and current acceptable guidelines.
• Each Point of Care Test has its own Quality Control
guidelines written into the procedure.
• Quality Control data is reviewed and evaluated in keeping
with CAP standards. Data is monitored in the Laboratory
by the Director or designee.
Standard WT.05.01.01
The Organization maintains records for waived testing.
Quality Control results are documented either on a log,
flow sheet or electronically.
• Example: Glucometer patient results and QC data flow
electronically to the glucose meter computer system, maintained in
the Laboratory. This system is interfaced with Meditech.
• Example: Occult Blood results are documented on flow sheets,
paper or online. (Notations by physicians in the medical record
are to be accompanied by QC results.)
• Individual tests results for all waived tests are associated with
Quality Control Results.