Brainscape's Knowledge GenomeTM


Top Flashcards (Certified)
All Flashcards

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

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

A

names, pictures, and designations

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

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

A

vision, mission, and goals and the DOH-LTO

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

• Written policy on _____and compilation of documented_____

A

management review

minutes of meeting

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Organizational chart should include:

A

Head: Pathologist
Chief MTs
Registered MTs

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

DOH LTO

A

Renewed every YEAR

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Proof of training

A

Certificate

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

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

A

at least once a week

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

PSP

A

Philippine Society of Pathologists

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

PRC

A

Professional Regulation Commission

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Clinical Laboratory

A

Primary
Secondary
Tertiary
Limited
Anatomic Laboratory

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

Molecular Laboratory

A

Genetics**
Immunohematology
Infectious

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

Anatomical Pathology

A

Surgical Pathology
Cytology
Immunonistopatholcay
Forensic Pathology
Autopsy

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

Clinical Pathology

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

Headed by a Pathologist who is certified by the..

A

Philippine Board of Pathology

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q
  • Clinical Laboratory Law of 1966
A

Republic Act No. 4688

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

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

A

1 competent RMT

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

: certificate of proficiency (SACCL)

A

rHIVda

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

(rHIVda)

A

rapid HIV diagnostic algorithm

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
NRL-SLH SACCL
STD AIDS Cooperative Center Laboratory
26
NRL for HIV
San Lazaro Hospital
27
AFB microscopy: certificate of training on
DSSM (NTRL) Direct Sputum Smear Microscopy
28
is indicated for suspected cases of tuberculosis
AFB-microscopy
29
• Bacteriology: certificate of training in bacteriology
Research Institute for Tropical Medicine
30
• Malaria smear: certificate of training in malaria smear
RITM
31
• Biosafety and Biosecurity Officer: certificate of training
RITM and/or UP- NTCBB Research Institute for Tropical Medicine National Training Center for Biosafety and Biosecurity
32
STAFFING PATTERN FOR RMT ANALYSTS
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
Bio safety vs Biosecurity
**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
Shift hours in a day
8 hours
35
In tertiary lab, at least hm RMTs are needed in the first shift
6
36
In secondary laboratory, at least hm RMTs are needed for the first shift?
5
37
In primary laboratory, at least hm RMTs are needed in 1st shift?
4
38
Primary lab shifts
8 (7+1 reliever) without Microbiology 9 (8+1 reliever) for Government Facilities
39
Secondary lab shifts
12 (11+1 reliever)
40
Tertiary lab shifts
12 (11+1 reliever) without Histopathology 13 (12+1 reliever) for Hospital-Based
41
Written policy and program for the proper maintenance and monitoring of physical plant and facilities Proposed schedule for…
preventive maintenance
42
Preventive maintenance vs Repair
**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
Preventive maintenance vs Repair Which is more important?
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
MOA
Memorandum of Agreement
45
Policy on disposal of wastes that conform with______ and____
Healthcare Waste Management Manual RA 6969 Toxic Substances and Hazardous and Nuclear Wastes Control Act of 1990)
46
, 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.
RA 6969 Toxic Substances and Hazardous and Nuclear Waste Control Act of 1990
47
A Memorandum of Agreement (MOA) is crucial in the disposal of laboratory wastes because….
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
EQUIPMENT/INSTRUMENTS
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
When should PM be done?
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
FDA certification is important because…
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
Temperature monitoring records should include:
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
Documented procedure for the retention of records which follows DOH standards Laboratory logbooks: Laboratory results: Laboratory requests:
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
In hematology dapat…
2 RMTs mag agree sa results
54
Purpose of QC
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
How to perform QC
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
(QAP)
Quality Assurance Plan
57
Purpose of management review
Minimize errors and achieve quality services
58
Written policy and procedure for handling know complaints/ client feedback
○ Available forms ○ Records and action taken
59
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
hiring, orientation, and promotion development and training certificates discipline, suspension, demotion, and termination job description or duties and responsibilities assignment
60
Types of Lab
Clin chem lab Anatomic lab Molecular lab
61
Tests in anatomic lab
Surgical pathology and cytology Autopsy Frozen section
62
Clinical Pathologist
Clin chem lab Molecular lab
63
Anatomic pathologist
Anatomic laboratory Autopsy Surgical patho Frozen section
64
Laboratory ____ and ______are accessible to the public
services and corresponding prices
65
● __________of laboratory services in each section/area
Documented and updated policies and procedures
66
Laboratory report forms bearing the…
name original digital signature PRC ID number of the head of the laboratory and the RMT analysts
67
Certificate of Performance in_____
EQAP with passing rate
68
● 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
DOH-licensed clinical laboratory contingency plan outsourced examinations Notarized MOA DOH-LTO
69
All documented policies, protocols, and procedures are _________by the_____
signed and approved head of the laboratory

Lab Management (18 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2025 Bold Learning Solutions. Terms and Conditions