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Lab Management > RULES AND REGULATIONS OF CLINICAL LABORATORIES IN PH > Flashcards

RULES AND REGULATIONS OF CLINICAL LABORATORIES IN PH Flashcards

1
Q

ORGANIZATION AND MANAGEMENT

A

• Updated organizational chart (with names, pictures, and designations) must be displayed in a conspicuous area

• The laboratory’s vision, mission, and goals and the DOH-LTO must also be displayed

• Written policy on management review and compilation of documented minutes of meeting

• Supporting documents for evaluation and monitoring of activities such as records, logbooks, checklist of supplies, inspection report, purchasing and procurement and acceptance of supplies, etc.

• Written policy and procedure for handling complaints/ client feedback

• Suggestion box must be visible to clients

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2
Q

• Updated organizational chart (with 3) must be displayed in a conspicuous area

A

names, pictures, and designations

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3
Q

• The laboratory’s(4) must also be displayed

A

vision, mission, and goals and the DOH-LTO

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4
Q

• Written policy on _____and compilation of documented_____

A

management review

minutes of meeting

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5
Q

Organizational chart should include:

A

Head: Pathologist
Chief MTs
Registered MTs

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6
Q

DOH LTO

A

Renewed every YEAR

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7
Q

Ngano need i document tanan?

A

For proof/ evidence if anything happens like kulang ang mga equipment, gamit, or if mag visit ang DOH then kumpleto ang papers

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8
Q

HUMAN RESOURCE MANAGEMENT

A

• Written policies and procedures on hiring, orientation, and promotion of personnel at all levels

• Written policies and procedures for staff development and training

• Proof of training through certificates, memos, budgetary allocations, written reports

• Written policies and procedures on discipline, suspension, demotion, and termination of personnel at all levels

• Written job description or duties and responsibilities of all laboratory personnel
• List of personnel with designation
• Areas of assignment indicated in the

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9
Q

Proof of training

A

Certificate

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10
Q

HEAD OF THE LABORATORY: THE PATHOLOGIST
Proof of supervisory________
OR_______

A

at least once a week for physical visit

once a month physical visit with at least twice a week of supervisory calls and or video conferencing

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11
Q

• For HOL of hospital-based laboratory: supervisory physical visit of…

A

at least once a week

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12
Q

• Proof of qualifications:

A

Updated resume

PRC certificate and valid PRC ID

Board Certificate and a Certificate of Good Standing from PSP

Notarized employment contract

Relevant training certificates

Proof of immunization

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13
Q

PSP

A

Philippine Society of Pathologists

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14
Q

PRC

A

Professional Regulation Commission

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15
Q

This certificate can be used as employment, business, or further proof of credibility and good moral character as a professional.

A

PRC CERTIFICATE OF GOOD STANDING

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16
Q

Clinical Laboratory

A

Primary
Secondary
Tertiary
Limited
Anatomic Laboratory

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17
Q

Molecular Laboratory

A

Genetics**
Immunohematology
Infectious

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18
Q

Anatomical Pathology

A

Surgical Pathology
Cytology
Immunonistopatholcay
Forensic Pathology
Autopsy

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19
Q

Clinical Pathology

A

Hematology
Immuno-serology
Immunohematology
Clinical Microscopy
Microbiology
Clinical Chemistry
Parasitology
Toxicology
Therapeutic Drug Monitoring

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20
Q

Headed by a Pathologist who is certified by the..

A

Philippine Board of Pathology

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21
Q
  • Clinical Laboratory Law of 1966
A

Republic Act No. 4688

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22
Q

REGISTERED MEDICAL TECHNOLOGISTS
At least______ per assigned area
RMTs with designated assignments must have proof of trainings

A

1 competent RMT

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23
Q

: certificate of proficiency (SACCL)

A

rHIVda

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24
Q

(rHIVda)

A

rapid HIV diagnostic algorithm

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25
Q

NRL-SLH SACCL

A

STD AIDS Cooperative Center Laboratory

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26
Q

NRL for HIV

A

San Lazaro Hospital

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27
Q

AFB microscopy: certificate of training on

A

DSSM (NTRL)

Direct Sputum Smear Microscopy

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28
Q

is indicated for suspected cases of tuberculosis

A

AFB-microscopy

29
Q

• Bacteriology: certificate of training in bacteriology

A

Research Institute for Tropical Medicine

30
Q

• Malaria smear: certificate of training in malaria smear

A

RITM

31
Q

• Biosafety and Biosecurity Officer: certificate of training

A

RITM and/or UP- NTCBB

Research Institute for Tropical Medicine

National Training Center for Biosafety and Biosecurity

32
Q

STAFFING PATTERN FOR RMT ANALYSTS

A
  1. Clinical Laboratory for Clinical and Anatomic Pathology
  2. Clinical Laboratory for Anatomic Pathology - At least one RMT per section
  3. Clinical Laboratory for Molecular Pathology - Will depend on the services offered
33
Q

Bio safety vs Biosecurity

A

Biosafety is about preventing accidental exposure to harmful biological agents through safe practices.

Biosecurity focuses on preventing the intentional misuse of biological materials, like theft or bioterrorism.

34
Q

Shift hours in a day

A

8 hours

35
Q

In tertiary lab, at least hm RMTs are needed in the first shift

A

6

36
Q

In secondary laboratory, at least hm RMTs are needed for the first shift?

A

5

37
Q

In primary laboratory, at least hm RMTs are needed in 1st shift?

A

4

38
Q

Primary lab shifts

A

8 (7+1 reliever) without Microbiology

9 (8+1 reliever) for Government Facilities

39
Q

Secondary lab shifts

A

12 (11+1 reliever)

40
Q

Tertiary lab shifts

A

12 (11+1 reliever) without Histopathology

13 (12+1 reliever) for Hospital-Based

41
Q

Written policy and program for the proper maintenance and monitoring of physical plant and facilities

Proposed schedule for…

A

preventive maintenance

42
Q

Preventive maintenance vs Repair

A

Preventive maintenance involves regular, scheduled upkeep of laboratory equipment to prevent breakdowns and ensure reliable performance.

Repair is the process of fixing equipment after it has already malfunctioned or failed.

43
Q

Preventive maintenance vs Repair

Which is more important?

A

Preventive maintenance is generally more important because it helps avoid equipment failures, ensures consistent performance, and extends the lifespan of laboratory instruments. It reduces the likelihood of costly repairs and downtime, keeping the lab running smoothly.

44
Q

MOA

A

Memorandum of Agreement

45
Q

Policy on disposal of wastes that conform with______ and____

A

Healthcare Waste Management Manual

RA 6969 Toxic Substances and Hazardous and Nuclear Wastes Control Act of 1990)

46
Q

, this program of the DENR-EMB covers the sound and proper management of industrial chemicals and hazardous wastes in all aspects of its life cycle, from importation, manufacture, distribution, transportation, use and disposal.

A

RA 6969 Toxic Substances and Hazardous and Nuclear Waste Control Act of 1990

47
Q

A Memorandum of Agreement (MOA) is crucial in the disposal of laboratory wastes because….

A

it clearly outlines the responsibilities and protocols for handling and disposing of hazardous materials. It ensures that all parties involved follow legal and safety guidelines, minimizing the risk of environmental contamination and ensuring compliance with regulations

48
Q

EQUIPMENT/INSTRUMENTS

A

List of available and functional laboratory equipment

Regular schedule including frequency of preventive maintenance and calibration

Record of repair reports

Written policy on contingency plan in case of equipment breakdown

49
Q

When should PM be done?

A

Daily/Weekly: Basic checks, like cleaning, calibration, and quality control tests.

Monthly/Quarterly: More thorough inspections and servicing, such as replacing worn parts or filters

50
Q

FDA certification is important because…

A

it ensures that medical devices, pharmaceuticals, and other health-related products meet safety, efficacy, and quality standards.

This certification helps protect public health by ensuring that products are reliable and have been thoroughly evaluated before reaching the market.

It also facilitates regulatory compliance and can enhance consumer trust and product credibility.

51
Q

Temperature monitoring records should include:

A
  1. Date and Time of each reading.
  2. Temperature Reading.
  3. Location of measurement.
  4. Name of the person monitoring.
  5. Action Taken if temperatures are outside the acceptable range.
52
Q

Documented procedure for the retention of records which follows DOH standards

Laboratory logbooks:

Laboratory results:

Laboratory requests:

A

dispose 2 years after the last entry provided that no item is subiect of a medico-legal case

must be disposed after 15 years

dispose 1 year after the release of the result

53
Q

In hematology dapat…

A

2 RMTs mag agree sa results

54
Q

Purpose of QC

A

The purpose of Quality Control (QC) is to ensure that laboratory tests and processes are accurate, reliable, and consistent by systematically monitoring and maintaining high standards throughout the testing process. QC helps identify and correct errors, ensure compliance with regulations, and enhance the overall quality of laboratory results.

55
Q

How to perform QC

A

To perform QC in a clinical laboratory using high, low, and normal controls, regularly run these control samples alongside patient tests. High controls test the accuracy at the upper limit, low controls at the lower limit, and normal controls at expected values. Compare the results of these controls to their expected ranges to ensure that the testing system is functioning correctly. Document the results and take corrective actions if any controls fall outside the acceptable ranges.

* Regularly run control samples with known values to check if test results fall within acceptable ranges.*

56
Q

(QAP)

A

Quality Assurance Plan

57
Q

Purpose of management review

A

Minimize errors and achieve quality services

58
Q

Written policy and procedure for handling know complaints/ client feedback

A

○ Available forms
○ Records and action taken

59
Q

HUMAN RESOURCE MANAGEMENT

● Written policies and procedures on ____,_____, and ______of personnel at all levels

● Written policies and procedures for staff____ and _____

● Proof of training through_____, memos, budgetary allocations, written reports

● Written policies and procedures on (4) of personnel at all level

● Written_____ and _____ of all laboratory personnel

● List of personnel with designation

● Areas of______ indicated in the posted work schedule

A

hiring, orientation, and promotion

development and training

certificates

discipline, suspension, demotion, and termination

job description or duties and responsibilities

assignment

60
Q

Types of Lab

A

Clin chem lab
Anatomic lab
Molecular lab

61
Q

Tests in anatomic lab

A

Surgical pathology and cytology
Autopsy
Frozen section

62
Q

Clinical Pathologist

A

Clin chem lab
Molecular lab

63
Q

Anatomic pathologist

A

Anatomic laboratory

Autopsy
Surgical patho
Frozen section

64
Q

Laboratory ____ and ______are accessible to the public

A

services and corresponding prices

65
Q

● __________of laboratory services in each section/area

A

Documented and updated policies and procedures

66
Q

Laboratory report forms bearing the…

A

name
original digital signature
PRC ID number

of the head of the laboratory and the RMT analysts

67
Q

Certificate of Performance in_____

A

EQAP with passing rate

68
Q

● Documented procedures on referral and outsourcing of examinations to another________

● Written policy on______ in case of equipment breakdown

● Records of______(in the event of machine breakdown)

●_____ on test referrals

●______ of referral testing laboratory

A

DOH-licensed clinical laboratory

contingency plan

outsourced examinations

Notarized MOA

DOH-LTO

69
Q

All documented policies, protocols, and procedures are _________by the_____

A

signed and approved

head of the laboratory

Lab Management (18 decks)

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