MLSLABMN: LABORATORY MANAGEMENT

LESSON 3: LABORATORY DOCUMENT

Transes by: Micah T. Dogomeo - MED224 │MIDTERMS - 2nd Term │A.Y. 2023 - 2024

Laboratory Accreditation - Follow policies, processes, and

procedures
Accreditation
- a procedure by which an authoritative Document Examples
body gives formal recognition that a - Quality manual
body or person is competent to carry - SOP
out specific tasks. - Personnel files
- Instrument files
Importance of Accreditation
- A good way to demonstrate Quality Manual
competence of the laboratory. - A document that was first required by
- High standard of services for clients - the ISO 9001:2015 standard for
patients, physicians. Quality Management Systems
- Improve quality of patient care - A top-level document that states the
services. company’s intentions for operating
and executing the processes within its
Documentation quality management system.
- Gives guidance and direction to an
Documentation organization’s own personnel
- Documentation plays a crucial role in
medical laboratories, serving as a Standard Operating Procedures
foundation for quality assurance, - A written document detailing how to
traceability, patient safety, and patient safely work with hazardous materials
care. - Helps to ensure a safe work
environment by documenting the key
risks associated with an activity and
Goal 1 Goal 2
how the risks can be controlled
- Allows you to - Provide an audit - A set of written instructions that
easily review trail for federal describes in detail how to perform a
and track your and state laboratory process a procedure safely
laboratory laboratory and efficiently.
activities. inspectors and
surveyors to see Personnel Files (201 Files)
that - An employee personnel file is a
requirements collection of documents associated
have been met. with each staff member’s employment
with the company.
Documents
Instrument Files
- Communicate information
- Compiled list of instruments/types of
- Updated periodically
equipment used in the laboratory.
 MLSLABMN: LABORATORY MANAGEMENT
LESSON 3: LABORATORY DOCUMENT

Transes by: Micah T. Dogomeo - MED224 │MIDTERMS - 2nd Term │A.Y. 2023 - 2024

- Instrument name Temperature Monitoring:

- Model number and serial number - Morning
- Purchase date - Afternoon
- Manufacturer and/or supplier contact - Night
information. - Usually Morning & Afternoon
- Technical service contact information.
- Repair service contact information. Quality Control
- Warranty information - Process of testing materials that have
- User guides a known concentration of the
substance being measured, prior to or
Records concurrently with patient testing.
- Collect data - GOAL: to obtain results that are within
- Do not need updating the expected target range of the
- Information generated in the control material, giving confidence
laboratory. that the test system is accurately
measuring the analyte.
[Another Record]
- Generated by the performing daily Equipment Maintenance
activities - Document instrument function checks,
- Provide evidence that activities were preventive maintenance, and any
performed other required monitoring.
- Permanent - Includes:
- Easily retrieved ➢ The frequency to perform the
- Not modified maintenance activity.
➢ Preventive maintenance
Record Examples ➢ Initials of the staff who
- Temperature monitoring performed the activity.
- Quality control ➢ Dates performed
- Equipment maintenance
- Calibration and Calibration Calibration
Verification
- Process of testing standards or
calibrators of known value and
Temperature and Humidity Logs
adjusting the instrument readout to
- Laboratory room, refrigerator must be
establish a correlation between the
checked and recorded daily, prior to
instrument’s measurement of the
testing QC or patient specimens. analyte being tested and its actual
- Monitor any temperature-dependent concentration.
equipment (such as water baths, heat
blocks, refrigerators, freezers, etc.)
Calibration Verification
- Confirms that the calibration setting
continues to allow test results to be
 MLSLABMN: LABORATORY MANAGEMENT
LESSON 3: LABORATORY DOCUMENT

Transes by: Micah T. Dogomeo - MED224 │MIDTERMS - 2nd Term │A.Y. 2023 - 2024

accurate throughout the reportable

Reagents, Materials 2 years
range of the test system. and Supplies
- Calibration must be performed Records
according to manufacturer’s
instruction at least once every six
months or more often if required by
your laboratory procedure.

Inventory
- Laboratory inventory comprises a
range of materials, equipment and
reagents required to conduct
procedures in the clinical laboratory
setting.

Record Examples
- Patient test results
- Proficiency testing
- Test tracking system
- Laboratory worksheets

Test Tracking System

- Calibration must be performed
according to manufacturer’s
instruction at least once every six
months or more often if required by
your laboratory procedures.

Retention of Records

Retention
Logbooks Permanent

Results 5 years

Requests 1 year

Worksheets 2 years

QC Records 2 years

PT Records 5 years