Laboratory Accreditation

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

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Accreditation

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The national accreditation body of the Philippines.

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PAB (Philippine Accreditation Bureau)

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Testing, certifying bodies, and other conformity that they can assess in the laboratory services.

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PAB (Philippine Accreditation Bureau)

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Executive Order of PAB

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Executive Order 802

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Under PAB

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LAD (Laboratory Accreditation Division)

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They determine the conformance to essential elements based on ISO 15189.

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LAD (Laboratory Accreditation Division)

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Under DOH

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HFSRB (Health Facilities and Services Regulatory Bureau)

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If a laboratory wants to be accredited under international standards they want the ISO, they need to accredit under_____

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PAB-LAD

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HFSRB are the ones who issue:

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1. PTC ( Permit To Construct )

2. LTO ( License To Operate)

3. COA ( Certificate Of Accreditation)

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Annual Inspection of Lab

Act on complains

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HFSRB (Health Facilities and Services Regulatory Bureau)

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A good way to demonstrate competence of the laboratory

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-Reduction of errors: Pre-analytical, Analytical, and Post-analytical processes

-Medicine development

-Continuous improvement

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plays a crucial role in the medical laboratories, serving as foundation for quality assurance, trace ability, patient safety, and patient care

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Documentation

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Goal 1

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Allows you to easily review and track laboratory activities

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Goal 2

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Provide an audit trail for federal and state laboratory inspectors

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-Communicate information

- Updated periodically

- Follow policies and processes, and procedures

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Documents

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What to do?

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Policies: General Direction

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How it happens?

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Processes:Events Flowcharts

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How to do it?

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Procedures: Step by step Instruction

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Document Examples

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▪ Quality Manual

▪ SOP

▪ Personnel Files

▪ Instrument Files

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is a document that was first required by the ISO 9001:2015 standard for Quality Management Systems.

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Quality Manual

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is a document that was first required by the________ standard for____________.

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ISO 9001:2015

Quality Management Systems

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Inside of quality manual

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-HOL: pathologist

-Sign, Date of signing, recorded in the manual

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A top-level document that states the company’s intentions for operating and executing the processes within it’s quality management system.

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Quality Manual

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Gives guidance and direction to an organization’s own personnel.

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Quality Manual

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Quality Manual Contains:

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1. Quality policy (Direction & Vision)

2. Scope of QMS

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

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Standard Operating Procedures

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

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Standard Operating Procedures

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

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Standard Operating Procedures

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

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Personnel Files (201files)

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201 files: updated

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Confidential

HR, Manager

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Included in personnel files

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1. Resume and job application

2. Employment contract (Notarized)

3. Diploma

4. Performance review

5. Disciplinary records

6. Training and seminars

7. PRC license

8. Insurance

9. Medical Files: Vaccinations, Records of exposure

10. Payroll status

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

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Instrument Files

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Instrument Files included:

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• 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

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Collect data

▪ Do not need updating

▪ Information generated in the laboratory

✓ Generated by performing daily activities

✓ Provide evidence that activities were performed

✓ Permanent

✓ Easily retrieved

✓ Not modified

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Record

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Record Examples

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▪ Temperature monitoring

▪ Quality control

▪ Equipment maintenance

▪ Calibration and calibration verification

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Laboratory room, refrigerator must be checked and recorded daily, prior to testing QC or patient specimens.

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Temperature and Humidity Logs

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Temperature Monitoring

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Morning

Afternoon

Night

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To monitor, at least__times to normal labs

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At least 2 times

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___times to the hospital laboratory or night duty lab

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3 times

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Monitor any___________

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Temperature dependent equipment (water baths, heat blocks, freezer)

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

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Quality Control

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Goal of quality Control

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obtain results that are within the expected target range of the control material, accurately measuring the analyte

ex. Creatinine

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

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Equipment Maintenance

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Equipment Maintenance includes:

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✓ The frequency to perform the maintenance activity

✓ Preventive maintenance

✓ Initials of the staff who performed the activity

✓ Date performed

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Process of testing standard or calibrations 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.

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Calibration

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Calibration contains

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✓ Set instrument to produce accurate results

✓ 5 or 6 MOS

✓ Equipment and serial numbers

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Confirms that the calibration setting continues to allow test result to be accurate throughout the reportable range of the test system

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Calibration Verification

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Calibration must be performed according to manufacturer’s instruction at least__________________ if required by your laboratory procedure.

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At least once every 6 month or more often

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Verification calibration

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New lot no.

Change of reagents

Instrument service or critical parts

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

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Inventory

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Lab inventory equipments, materials, reagent:

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Chemicals, Solvents, Controls, Standards, Glassware, Plasticware, Equipment reagents, Pipette tips, Gloves

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You cannot use any machine in the lab if you don't have control. Because the tendency is not sure if the machine will come out if it enters your control range. So it can come out with results.

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INCLUDE:- Supplies and reagents in the lab

- Lot number

- Date purchased

- Name of supplier

- Quantity used

- Quantity left ( stocks)

▪ At least monthly updated

Without proper inventory:

▪ Delays, errors, additional expenses

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Record Examples

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-patient test result

-proficiency testing

-test tracking system

-laboratory worksheet

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should have a duplicate copy. , it can be written in a logbook, it can be printed out or stored in your computer system.

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Patient test result

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also known as your EQA or external quality assurance.

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Proficiency Testing

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Retention of records

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Logbooks – permanent

Result – 5 years

PT Records – 5 years

Worksheets – 2 years

QC Records – 2 years

Reagents, Materials and Supplies Record – 2 year

Request – 1 year