Arkray Assure PRISM MULTI Reference Manual

SECTION
C
21
Regulatory Review and Guidelines
for QA/QC Protocols
COMPETENCY CHECKLIST
Joint Commission on
Accreditation of Healthcare
Organizations (JCAHO)
Clinical and Laboratory
Standards Institute (CLSI)
(Formerly NCCLS)
Clinical Laboratory
Improvement
Amendments (CLIA)
Personnel/Training • Staff members can describe
or demonstrate their roles and
responsibilities (HR.2.20).
• Participate in ongoing
in-services.
• Education is documented
(HR.2.30).
• Competence to perform job
responsibilities is assessed,
demonstrated, and maintained
(HR.3.10).
• Formal training and written
examination.
• Follow manufacturer’s
instructions.
Quality Assurance • Current and complete policies
are available to the person
performing the test.
• Written policies and
procedures for: specimen
collection,identication,and
requiredlabeling;specimen
preservation;instrument
calibration;qualitycontroland
remedialaction;equipment
performanceevaluation;
test performance.
• Follow manufacturer’s instructions
for calibration.
• Written procedure manual.
• Manual contains principles of
operation, reagents/equipment,
calibration, quality control, stepwise
procedure, reporting results,
procedure limitations, references,
supplemental material, review
and updates.
• Follow manufacturer’s
instructions.
Quality Control • Written quality control plan
thatspecieshowprocedures
will be controlled.
• At the least, perform as
frequently as recommended
by manufacturer.
• Should include two levels of
control solution.
• At the least, quality control
procedures are performed
once each day on each
instrument used for resident
testing (PC.16.50).
• On each day of use, two control
solutions(Level1and2)shouldbe
performed per instrument.
•Priortothersttestoftheday,
each operator is to perform a quality
control test.
• Additional checks should be
performed when:
• A new bottle of strips is opened.
• Each time a reagent lot is changed.
• To ensure the strips and meter
are functioning properly.
• Follow manufacturer’s
instructions.
Linearity/Calibration •Linearitynotcoveredin
the standards.
•Initiallyandasspeciedby
manufacturer or as required by
government or accrediting bodies.
• Follow manufacturer’s
instructions.
Prociency Training •Notspecied. • Participate in program that
meets accreditation, federal
and state regulations.
•Notspecied.
Inspections • Currently triennial (APP-5). • Not a certifying agency. • Not subject to routine survey.
• Conducted only when
authorized by the RO.
ARKRAY provides this checklist as a guideline only. These guidelines are subject to change by the
regulating body at any time. Utilize this checklist in accordance with your facility’s policy.

Arkray Assure PRISM MULTI Specifications

General

Brand	Arkray
Model	Assure PRISM MULTI
Category	Blood Glucose Meter
Language	English