3: LABORATORY DOCUMENTATION Flashcards
- A procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks.
ACCREDITATION
- PAB
Philippine Accreditation Bureau
National Accreditation Body of the Philippines
- PAB (Philippine Accreditation Bureau)
Accredited for inspection, testing, certifying bodies, and other confirmative assess of laboratories
According to E.O. 802
- PAB (Philippine Accreditation Bureau)
Under PAB
- LAD (Laboratory Accreditation Division)
Determine the conformance to essential elements based on ISO15189
- LAD (Laboratory Accreditation Division)
If a laboratory wants to be accredited under international standards, they need to accredit under ________
PAB-LAB
- HFSRB
Health Facilities and Services Regulatory Bureau
Under DOH
- HFSRB
They monitor health facilities and services to ensure their continuous compliance within the regulatory standards
Annual inspections of labs
Act on complaints
- HFSRB (Health Facilities and Services Regulatory Bureau)
PTC
Permit to construct
LTO
License to Operate
COA
Certificate of Accreditation
- A good way to demonstrate competence of the Laboratory.
- High standard of services for clients - patients, physicians
- Improve quality of patient care services.
IMPORTANCE OF ACCREDITATION
- Improves laboratory medicine and all processes inside the lab
- Reduction of Errors (in pre- analytical, analytical, post- analytical)
- Accurate and Rapid DX (Diagnosis of patients)
- Acceleration and efficient of treatment
- Med Development
- Continuous Improvement
IMPORTANCE OF ACCREDITATION
- plays a crucial role in medical Laboratories, serving as a foundation for quality assurance, traceability, patient safety, and patient care.
- Useful when problem arises (serve as evidence)
- Kept by the lab
- Either paper or electronic
- Should be clear, concise, user-friendly, accurate, up-to-date
- Essential part of daily operations
DOCUMENTATION
GOAL 1
Allows you to easily review and track your Laboratory activities
GOAL 2
Provide an audit trail for federal and state Laboratory inspectors and surveyors to see that requirements have been met
DOCUMENTATION
To follow quality system
Answers “What to do?”
- Follow (Policies: General Direction)
Answers “How it happens?”
Flowcharts
- Processes (Events)
Answers “How to do it?”
- and Procedures (Step-By-Step instructions)
- is a document that was first required by the ISO 9001:2015 standard for Quality Management Systems (QMS).
- A top-level document that states the company’s intentions for operating and executing the processes within its quality management system.
- Gives guidance and direction to an organization’s own personnel.
- Must be written, prepared, and approved by the head of the lab: Pathologist
- Must have official signature, date of signing, recorded in the manual
- Should contain:
Quality Policy (Direction and Vision of Organization)
Scope of QMS
QUALITY MANUAL
- A written document detailing how to safely work with hazardous materials.
- Helps to ensure a safe work environment by documenting the key risks associated with an activity and how the risks can be controlled.
- A set of written instructions that describes in detail how to perform a laboratory process or procedure safely and efficiently.
- Consistently by RMTs
STANDARD OPERATING PROCEDURES (SOP)
- is a collection of documents associated with each staff member’s employment with the company.
- Included:
Resume and job application
Employment contract (notarized)
Diploma
Performance review
Disciplinary records
Training and seminars
PRC license
Insurance
Medical files: vaccinations, records of exposure
Payroll status - Separate folder/clearbook containing 201 files
Confidential
Handled by HR, Manager
EMPLOYEE PERSONNEL FILE
- Compiled list of instruments/ types of equipment used in the Laboratory.
- Included:
instrument name
model number and serial number
purchase date
manufacturer and/or supplier contact information
technical service
contact information
repair service contact information
warranty information
user guides
INSTRUMENT FILES
- Collect Data
- Do not need updating
- Information generated in the laboratory
- Generated by performing
- Provide evidence that activities were performed
- Permanent (when, who, what happened)
- Easily retrieved
- Not modified
- E.g.
QUALITY CONTROL
EQUIPMENT MAINTENANCE
TEMPERATURE MONITORING
CALIBRATION AND CALIBRATION VERIFICATION
RECORDS
- Laboratory room, refrigerator must be checked and recorded daily, prior to testing QC or patient specimens.
- Monitor any temperature-dependent equipment (such as water baths, heat blocks, refrigerators, freezers, etc)
TEMPERATURE AND HUMIDITY LOGS
- Temp monitoring: (at least 2 times – normal lab, 3 times for hospital lab)
Morning
Afternoon
Night
- Process of testing materials that have a known concentration of the substance being measured, prior to or concurrently with patient testing.
A test is performed with a known material to measure the accuracy of the test system
QUALITY CONTROL
- Run a normal and abnormal control daily
RED
GREEN
– abnormal control
– normal control
- GOAL: To obtain results that are within the expected target range of the control material, giving confidence that the test system is accurately measuring the analyte.
QUALITY CONTROL
- Document instrument function, checks preventive maintenance, and any other required monitoring
- Includes:
the frequency to perform the maintenance activity
preventive maintenance
initials of the staff who performed the activity
dates performed
EQUIPMENT MAINTENANCE
- Process of testing standards or calibrators of known value and adjusting the instrument readout to establish correlation between the instrument’s measurement of the analyte being tested and its actual concentration.
- Confirms that the calibration setting continues to allow test results to be accurate throughout the reportable range of the test system
- Sets instruments to produce accurate results
- Included:
Equipment name
serial number
CALIBRATION
- Calibrate every ____________
5 or 6 months
- Calibration must be performed according to manufacturer’s instruction at least once every six months or more often if required by your laboratory procedure.
- Included:
New lot. No.
Changes of reagents
Instrument service or critical parts
CALIBRATION VERIFICATION
- comprises a range of materials, equipment and reagents required to conduct procedures in the clinical laboratory setting.
- Without proper inventory, a lab could experience significant delays, errors, and additional expenses.
- At least monthly updated
Supplies
Reagents
Chemicals
Solvents
Controls
Standards
Glassware
Plasticware
Equipment
Pipette tops
Gloves
INVENTORY
INVENTORY
Supplies and reagents in the lab
Lot number
Date purchased
Name of supplier
Quantity used
Quantity left (stocks)
Should have duplicate copy (either logbook or system)
- PATIENT TEST RESULTS
Also known as EQA (External quality assurance)
Included:
PT enrollment order form
Instructors sample
PT Score Report
- PROFICIENCY TESTING (PT)
Patient test results
Basis before printing/encoding results
- LABORATORY WORKSHEETS
- LOGBOOKS
PERMANENT
- RESULTS
5 YEARS
- REQUESTS
1 YEAR
- WORKSHEETS
2 YEARS
- QC RECORDS
2 YEARS
- PT RECORDS
5 YEARS
Reagents, Materials and Supplies Records
2 YEARS
