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LABORATORY MANAGEMENT > 3: LABORATORY DOCUMENTATION > Flashcards

3: LABORATORY DOCUMENTATION Flashcards

1
Q
  • A procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks.
A

ACCREDITATION

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2
Q
  • PAB
A

Philippine Accreditation Bureau

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3
Q

National Accreditation Body of the Philippines

A
  • PAB (Philippine Accreditation Bureau)
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4
Q

 Accredited for inspection, testing, certifying bodies, and other confirmative assess of laboratories
 According to E.O. 802

A
  • PAB (Philippine Accreditation Bureau)
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5
Q

 Under PAB

A
  • LAD (Laboratory Accreditation Division)
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6
Q

 Determine the conformance to essential elements based on ISO15189

A
  • LAD (Laboratory Accreditation Division)
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7
Q

 If a laboratory wants to be accredited under international standards, they need to accredit under ________

A

PAB-LAB

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8
Q
  • HFSRB
A

Health Facilities and Services Regulatory Bureau

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9
Q

 Under DOH

A
  • HFSRB
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10
Q

 They monitor health facilities and services to ensure their continuous compliance within the regulatory standards
 Annual inspections of labs
 Act on complaints

A
  • HFSRB (Health Facilities and Services Regulatory Bureau)
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11
Q

 PTC

A

Permit to construct

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12
Q

 LTO

A

License to Operate

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13
Q

 COA

A

Certificate of Accreditation

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14
Q
  • A good way to demonstrate competence of the Laboratory.
  • High standard of services for clients - patients, physicians
  • Improve quality of patient care services.
A

IMPORTANCE OF ACCREDITATION

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15
Q
  • 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
A

IMPORTANCE OF ACCREDITATION

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16
Q
  • 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
A

DOCUMENTATION

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17
Q

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

A

DOCUMENTATION

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18
Q

 To follow quality system
 Answers “What to do?”

A
  • Follow (Policies: General Direction)
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19
Q

 Answers “How it happens?”
 Flowcharts

A
  • Processes (Events)
20
Q

 Answers “How to do it?”

A
  • and Procedures (Step-By-Step instructions)
21
Q
  • 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
A

QUALITY MANUAL

22
Q
  • 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
A

STANDARD OPERATING PROCEDURES (SOP)

23
Q
  • 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
A

EMPLOYEE PERSONNEL FILE

24
Q
  • 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
A

INSTRUMENT FILES

25
Q
  • 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
A

RECORDS

26
Q
  • 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)
A

TEMPERATURE AND HUMIDITY LOGS

27
Q
  • Temp monitoring: (at least 2 times – normal lab, 3 times for hospital lab)
A

 Morning
 Afternoon
 Night

28
Q
  • 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
A

QUALITY CONTROL

29
Q
  • Run a normal and abnormal control daily
     RED
     GREEN
A

– abnormal control
– normal control

30
Q
  • 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.
A

QUALITY CONTROL

31
Q
  • 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
A

EQUIPMENT MAINTENANCE

32
Q
  • 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
A

CALIBRATION

33
Q
  • Calibrate every ____________
A

5 or 6 months

34
Q
  • 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
A

CALIBRATION VERIFICATION

35
Q
  • 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
A

INVENTORY

36
Q

INVENTORY

A

 Supplies and reagents in the lab
 Lot number
 Date purchased
 Name of supplier
 Quantity used
 Quantity left (stocks)

37
Q

 Should have duplicate copy (either logbook or system)

A
  • PATIENT TEST RESULTS
38
Q

 Also known as EQA (External quality assurance)
 Included:
 PT enrollment order form
 Instructors sample
 PT Score Report

A
  • PROFICIENCY TESTING (PT)
39
Q

 Patient test results
 Basis before printing/encoding results

A
  • LABORATORY WORKSHEETS
40
Q
  • LOGBOOKS
A

PERMANENT

41
Q
  • RESULTS
A

5 YEARS

42
Q
  • REQUESTS
A

1 YEAR

43
Q
  • WORKSHEETS
A

2 YEARS

44
Q
  • QC RECORDS
A

2 YEARS

45
Q
  • PT RECORDS
A

5 YEARS

46
Q

Reagents, Materials and Supplies Records

A

2 YEARS

LABORATORY MANAGEMENT (6 decks)

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