LABORATORY MANAGEMENT Flashcards
a goal that the organization’s sub-unit expect to accomplish
Mission
to handle and what language
maneggiare, Italian
sum-total of all characteristics of a product/service that has a bearing upon the utilization of the product to the entire satisfaction of the consumer
Quality
planned activities designed to provide a quality product
Quality Control
guidance for quality in manufacturing and service industries
ISO (International Organization for Standardization)
for using the resources established
Accountability
quality management in the clinical laboratory
ISO 15189:2007
the art of conducting and what is the language
ménagement, French
includes people, equipment, supplies and money
Resources
the foundation of international medical laboratory quality management
ISO 15189:2007
standards, guidelines, and best practices for quality in medical laboratory testing
CLSI (Clinical and Laboratory Standards Institute)
planned activities designed to ensure that the quality control activities are being properly implemented
Quality Assurance
needed to direct the team toward the goal
Authority
to lead by the hand
manu agere, Latin
model for QA in design, development production, installation and servicing
ISO 9001:2000
for achieving the goals assigned
Responsibility
describes quality system model, 12 essentials
HS1-AS
facility that perform chemical and microscopic examination of various body fluids
clinical laboratory
surgical pathology, immunopathology, cytology and postmartem examination
Anatomic Pathology
clinical chemistry, hematology, microbiology, parasitology
clinical laboratory
laboratory that operates within hospital
hospital
does laboratory that operates on its own or a start of an activity other than a hospital
free standing
test cleared by the FDA for home use, employ simple methods, likelihood of erroneous result is negligible pose no risk or harm to the patient if the test is performed incorrectly
waived test
the examination personally performed by a practitioner; procedure categorized as moderately complex, primary instrument for performing the test is microscope, specimen, is labile, control materials are not available; specimen handling is limited
provider-performed microscopy
performs only waived test and one more tests designated as moderately complex by the FDA
moderately complex test
performs one or more test specifically listed or more test specifically listed or included in the waived or moderately complex categoriescol
highly complex test
Manual methods for cell counts and coagulation
Platelet aggregometry
Differentials that include interpretation of typical cells
hematology
All procedure requiring identifying of susceptibility determination of organisms after transfer from primary culture medium
Grams stain from sources other than urethral or endocervical origin
Microbiology
traditional setting for performance of diagnostic testing located in a hospital where specimens from patients are sent to be tested
central laboratory testing
testing site away from traditional laboratory such as bedside in the operating rooms, or recovery areas or ROC-30 even home testing
point of care testing
air tempt
68F-76F
humidity
20-60%
air flow
12 air exchanges/hour
how many percent does base should provide in space than suspended cabinets
20-30%
what is the space requirement per hospital bed
27-40 net sq feet
room should have two exits
> 100 sq ft
corridors used for patients must be
8 feet wide
corridors not for patient use must be
3 ft 8 inches wide
hands free eyewash unit within
100 feet
lab counter width
2 feet 6 inches
lab counter to wall clearance
4 feet
lab counter to counter clearance
7 feet
desk height
30 inches
desk space
3 sq feet
human body standing
4 sq feet
human body sitting
6 sq feet
An Act Regulating the Operation and Maintenance of Clinical Laboratories and Requiring Registration of the Same with the Department of Health, Providing Penalty for the Violation Thereof, and for other Purposes
RA 4688
Rules and Regulations Governing the Establishment, Operation, and Maintenance of Clinical Laboratories in the Philippines
AO 59 S.2001
Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines
A.O. 2007-0027
minimum of 10 sq
primary
minimum of 20 sq
secondary
minimum of 60 sq
tertiary