Lesson 2

Question 1

A procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks.

Answer 1

ACCREDITATION

Question 2

_________ determines the conformance to essential elements based on ______

Answer 2

LABORATORY ACCREDITATION DIVISION (LAD)

ISO 15189

Question 3

__________ is central to testing and certifying bodies and other bodies offering conformity assessment services in accordance with ________

Answer 3

PHILIPPINE ACCREDITATION BUREAU (PAB)

Executive Order 802.

Question 4

Monitoring of health facilities and services to ensure continuous compliance of health facilities with the regulatory standards (annual inspection of labs).

Answer 4

HEALTH FACILITY AND SERVICES REGULATORY BUREAU (HFSRB)

Question 5

HEALTH FACILITY AND SERVICES REGULATORY BUREAU (HFSRB) issues _________, _________, and __________

Answer 5

Issue Permits to Construct (PTC), License to Operate (LTO), and Certificate of Accreditation.

Question 6

Plays a crucial role in medical laboratories, serving as a foundation for quality assurance, traceability, patient safety, and patient care.

Answer 6

DOCUMENTATION

Question 7

There must be _____ copies of test results.

for?

Answer 7

four

For inventory
For the laboratory
For the nurse station
For the patient

Question 8

TYPES OF DOCUMENTATION

Answer 8

Paper
Electronic

Question 9

Goals of Documentation

Answer 9

Allows you to review and track your laboratory activities.

Provide an audit trail for federal and state laboratory inspectors and surveyors to see that requirements have been met.

Question 10

Quality Manual was first required by the _________ standard for ___________

Answer 10

ISO 9001:2015
Quality Management Systems.

Question 11

A top-level document that states the company’s intention for operating and executing the processes within the quality management systems

Answer 11

Quality Manual

Question 12

provides direction and vision for organization.

Answer 12

Quality policy

Question 13

A written document detailing how to safely work with hazardous materials.

Answer 13

STANDARD OPERATING PROCEDURES (SOP)

Question 14

Helps to ensure a safe work environment by documenting the key risks associated with an activity and how the risks can be controlled.

Answer 14

STANDARD OPERATING PROCEDURES (SOP)

Question 15

A set of written instructions that describes in detail how to perform a laboratory process of procedure safely and efficiently.

Answer 15

STANDARD OPERATING PROCEDURES (SOP)

Question 16

a collection of documents associated with each staff member’s employment with the company.

Answer 16

PERSONNEL FILES (201 FILES)

Question 17

Compiled list of instruments/types of equipment used in the laboratory.

Answer 17

INSTRUMENT FILES

Question 18

INSTRUMENT FILES should include :

Answer 18

Instrument name
Model number and serial number
Purchase date
Manufacturer and/supplier contact information
Technical services Contact information.
Repair service contact information
Warranty information
User guides

Question 19

Contains information that does not need updating.

Answer 19

RECORDS

Question 20

Process of testing materials that have a known concentration of the substance being measured, prior to or concurrently with patient testing.

Answer 20

QUALITY CONTROL

Question 21

Document instrument function checks, preventive maintenance, and any other required monitoring.

Answer 21

EQUIPMENT MAINTENANCE

Question 22

Process of testing standards of calibrators of known value and adjusting the instrument readout to establish a correlation between the instrument’s measurement of the analyte being tested and its actual concentration.

Answer 22

CALIBRATION

Question 23

Every when is calibration done

Answer 23

Done 5 to 6 months, but sometimes quarterly based on laboratory policies.

Question 24

Confirms the calibration setting continues to allow test results to be accurate throughout the reportable range of test systems

Answer 24

CALIBRATION VERIFICATION

Question 25

sometimes called External Quality Assurance (EQA) and this is done to check if machines provide accurate results.

Answer 25

Proficiency Testing

Question 26

Comprises a range of materials, equipment, reagents required to conduct procedures in the clinical laboratory setting.

Answer 26

INVENTORY

Question 27

RETENTION OF RECORDS

• Log Books
• Results
• Requests
• Worksheets
• Quality Control Records
• Proficiency Testing Records
• Reagents, Materials, & Supplies Records (For inventory purposes)

Answer 27

• Permanent
• 5 years
• 1 year
• 2 years
• 2 years
• 5 years
• 2 years