(M) Lec 2: Setting up and Managing a Lab Flashcards
● Recommend layout and design
● Select the technology that you want and design the test menu.
● Quantify the staffing requirements.
● Provide cost-benefit analysis.
A. LABORATORY PLANNING
B. PRE-OPERATIONS SET-UP
C. OPERATIONS MANAGEMENT
D. QUALITY OVERSIGHT/EXCELLENCE
A
● Develop quality management system
● Procure ** supplies and equipment.**
● Coordinate recruitment.
● Develop ** standard operating procedures.**
● Train laboratory personnel.
● Validate test menu.
● Build interface for on-site and send-out tests.
A. LABORATORY PLANNING
B. PRE-OPERATIONS SET-UP
C. OPERATIONS MANAGEMENT
D. QUALITY OVERSIGHT/EXCELLENCE
B
● Analyze specimens and report results.
● Develop KPIs to monitor performance.
● Manage equipment maintenance.
● Provide specimen transportation services to referral laboratories.
● Manage inventory of reagents and consumables.
● Participate in relevant committees (Quality, POCT, etc..
A. LABORATORY PLANNING
B. PRE-OPERATIONS SET-UP
C. OPERATIONS MANAGEMENT
D. QUALITY OVERSIGHT/EXCELLENCE
C
● Monitor and enhance the quality management system.
● Implement continuous survey/inspection readiness.
● Ensure ongoing sta training and compliance with all
applicable regulations.
● Conduct regular internal and external results.
A. LABORATORY PLANNING
B. PRE-OPERATIONS SET-UP
C. OPERATIONS MANAGEMENT
D. QUALITY OVERSIGHT/EXCELLENCE
D
DOH ADMINISTRATIVE ORDER
There are regulations that you need to comply with before you set up a laboratory (2)
- AO No. 2007-0027
- AO No. 2021-0037
DOH ADMINISTRATIVE ORDER
➔ New rules and regulations governing the
Regulation of Clinical Laboratories in the
Philippines.
AO No. 2021-0037
➔ June 11, 2021
DOH ADMINISTRATIVE ORDER
➔ Revised rules and regulations governing the
Licensure and regulations of Clinical Laboratories
in the Philippines .
➔ Has been the regulation that we have been
following until they released the new AO which is known as the New Rules and Regulations converting the regulation of clinical laboratories in the Philippines, (AO No. 2021-0037).
AO No. 2007-0027
➔ August 22, 2007
MATCH THE TERMINOLOGIES
1. BHFS
2. CL
3. Critical Values
4. EQAP
A. A facility where tests are done on specimens from the human body to obtain information about the health status of a patient for the prevention, diagnosis, and treatment of a disease.
B. Under the department of health; an agency that
issues your license to operate.
C. You have to generate a value that is close to the reference value of that unknown sample and your results will be evaluated together with your peer group.
D. These are panic values; originally described as life
threatening unless something is done promptly and for which some corrective action could be undertaken.
SORRY ANTOK
BADC
MATCH THE TERMINOLOGIES
- A checklist used by the regulatory offices of the Department of Health during their inspection visit.
- These laboratories are government hospital
laboratories designated by the doH to provide special functions and services for specific disease areas. - These are laboratory testing units capable of
performing limited testing capability of the
different diagnostic procedures. - Refers to extension of the main clinical laboratory then it has to be located within the facilities
compound or premises.
A. Inspection Tool
B. MCL
C. NRL
D. SCL
ACBD
MATCH
- Results of which should be released within one hour after the procedure according to the AO as compared to your routine test.
- Commonly requested test in the laboratory wherein results are not required to be released immediately upon completion
A. Routine test
B. STAT tests
C. POCT
B, A
Skip ko na classif kasi familiar naman kau
ayan para sa hindi
● By Ownership
➔ Government
➔ Private
● By function
➔ Clinical pathology
➔ Anatomic pathology
➔ Molecular pathology
● By institutional character
➔ Institution based (IB)
➔ Free-standing (Non-IB)
● By service Capability
➔ General CL
- Primary
- Secondary
- Tertiary
- ➔ Special CL
- Blood Typing Secondary Category
- Offer highly specialized laboratory services that are usually not provided by a general clinical laboratory.
Includes NRL.
In the new AO, what clinical laboratories were added.
Three
- CL for Clinical pathology & Anatomical pathology
- CL for Anatomical pathology only
- CL for Molecular Pathology
GENERAL GUIDELINES
DOH-LTO shall be secured from the?
DOH regulatory office
GENERAL GUIDELINES
TOF. Only DOG-licensed IB-CL may have a SCL (which is within the premises of the HF.
T
pa-send ano meaning DOG arf arf
GENERAL GUIDELINES
TOF. DOH-licensed CL can perform any exam/testing beyond its authorized SC.
F
GENERAL GUIDELINES
Head of the CL
Pathologist
GENERAL GUIDELINES
A pathologist shall be certified by
APO/AIPO of the PRC
GENERAL GUIDELINES
TOF. CL for Research/teaching purposes is not required to register with the DOH-HFSRB.
F
alam ko hindi naman talaga pero ewan baka ginagaslight ko sarili ko
GENERAL GUIDELINES
What law/principle conforms to “Prices for laboratory services made accessible to the public”
UHC law
and others if may maisip k pa
GENERAL GUIDELINES
DOH-LTO shall be approved and issued by the?
Central Office, Director IV (or Director III, the absence of the Director IV).
GENERAL GUIDELINES
TOF. DOH-LTO may be revoked, suspended, or modified in full or in part for any false statement or failure to comply with the rules and regulations.
T
Specific guidelines
● Human resources
● Equipment
● Glasswares, reagents, and supplies
● Administrative policies and procedures
● Quality assurance program
● Communication and records
● Physical facilities/work environment
● Referral of examinations outside of the clinical laboratory.
CLASSIFICATIONS OF LABORATORIES ACCORDING TO AO 2007-0027
Quantitative Platelet Count
A. Primary B. Secondary C. Tertiary
B
CLASSIFICATIONS OF LABORATORIES ACCORDING TO AO 2007-0027
Microbiology Culture & Sensitivity (C/S)
- Aerobic and anaerobic (hospital-based)
- Aerobic or anaerobic hospital. (non-hospital based)
A. Primary B. Secondary C. Tertiary
C
CLASSIFICATIONS OF LABORATORIES ACCORDING TO AO 2007-0027
Routine Urinalysis & Fecalysis
A. Primary B. Secondary C. Tertiary
A
you can answer B or C since min requirements siya but be specific nalang thx
CLASSIFICATIONS OF LABORATORIES ACCORDING TO AO 2007-0027
Qualitative Platelet Count
A. Primary B. Secondary C. Tertiary
A (routine hematology)
CLASSIFICATIONS OF LABORATORIES ACCORDING TO AO 2007-0027
Blood typing (for hospital-based)
A. Primary B. Secondary C. Tertiary
A
CLASSIFICATIONS OF LABORATORIES ACCORDING TO AO 2007-0027
Cross matching, gram staining, KOH
A. Primary B. Secondary C. Tertiary
B
CLASSIFICATIONS OF LABORATORIES ACCORDING TO AO 2007-0027
Special hematology (including coagulation procedures)
A. Primary B. Secondary C. Tertiary
C
CLASSIFICATION OF LABORATORIES
- fecalysis
- Urinalysis
- Fecal Occult Blood Test
- Pregnancy Test (Rapid Test Kits - Lateral Flow)
- Wet Smear for Trichomonas
Clinical Microscopy (primary)
walang secondary and tertiary ang CM
CLASSIFICATION OF LABORATORIES
- Fasting and Random Blood Sugar
- Oral Glucose Tolerance Test
- Lipid Profile (Total Cholesterol, HDL, LDL, Triglycerides)
- Creatinine
- Blood Urea Nitrogen
- Blood Uric Acid
Clinical Chemistry Primary
CLASSIFICATION OF LABORATORIES
- Serum
- Electrolytes (Sodium, Potassium, Chloride)
- ALT
- AST
CC Secondary
CLASSIFICATION OF LABORATORIES
Examinations Hospital-based:
* Arterial Blood
* Gases
CC tertiary
CLASSIFICATION OF LABORATORIES
- Complete Blood Count (Hemoglobin, Hematocrit, Red Blood Cell Count, White Blood Cell Count with Differential Count, Quantitative Platelet Forward and reverse ABO grouping and Rh (D) typing (tube method)
Hematology (primary)
CLASSIFICATION OF LABORATORIES
Hospital based: Coagulation studies (PT, aPTT)
Hematology Secondary
CLASSIFICATION OF LABORATORIES
- Dengue Syphilis
- Hepatitis B (Screening)
- HIV (Screening)
- Using Rapid Test Kits
Serology/Immunology (primary)
CLASSIFICATION OF LABORATORIES
Tumor markers, thyroid function tests and hepatitis profile
Serology/Immunology
CLASSIFICATION OF LABORATORIES
TB (DSSM) of Nucleic Acid Amplification Test - for government facilities
Microbiology (primary)
CLASSIFICATION OF LABORATORIES
- Gram Stain
- КОН
Micro (Secondary)
CLASSIFICATION OF LABORATORIES
- Culture and sensitivity (aerobic and anaerobic)
Microbiology (tertiary)
CLASSIFICATION OF LABORATORIES
Pap smear
AP (secondary)
walang primary sa anatomical pathology
CLASSIFICATION OF LABORATORIES
For Hospital-based: Cytology and Histopathology
Anatomic pathology (tertiary)
Pls skim thru the staffing pattern for RMT analysis
THX
For tertiary laboratory, only 3 sections function during PM and night shifts
- Microscopy
- Hematology
- Clinical Chemistry
Working hours (min and max)
8 hours, Max of 12 hours
In manual testing, how many tests is done per RMT?
two answers
- 50 tests/RMT/8 hours
- 75 tests/RMT/12 hours
basis ay 10 mins / test
In automated testing, how many tests is done per RMT?
2
100 tests/RMT/8hrs
150 tests/RMT/12 hours
Staffing pattern for RMT analysts
Total of RMTs for primary (w/o microbiology)
8 (7 +1 reliever)
Staffing pattern for RMT analysts
Total of RMTs for primary (government facilities)
9 (8 + 1 reliever)
Staffing pattern for RMT analysts
Total of RMTs for secondary
12 (11 + 1 ) reliever
Staffing pattern for RMT analysts
Total RMT for tertiary (w/o histopathology)
12 (11 + 1 reliever)
Staffing pattern for RMT analysts
total RMTs for tertiary (hospital-based)
13 (12 + 1 reliever)
THINGS TO CONSIDER IN HUMAN RESOURCE:
Oversee the operation of CL
HOL
ewan ko teh nasa notes
THINGS TO CONSIDER IN HUMAN RESOURCE:
Adequate full-time, number depending on workload.
RMTs
- Creating environments that enhance the quality
of life and wellness of lab users is one of the highest priorities in designing clinical laboratories today. - Proper safety/containment strategies reduce exposure to hazards.
- The process of introducing a new staff member to
the new work environment and to their specific
tasks or duties. - Management must establish appropriate
personnel qualifications for all positions in the
laboratory.
A. Recruitment
B. Orientation
C. Human Resource
D. Staffing requirements
DCBA
PRE-OPERATIONS SET-UP
Staff development follows what principle?
old and new
Continuing professional education (upgrade KAS - Knowledge, Attitudes and Skills)
Steps in Procurement:
- Planning phase
- Implementation phase
- Monitoring and evaluation phase
● Needs Assessment
● Procurement planning
➔ Assign roles is procurement ● Product selection
➔ Determine and set minimum performance ➢ Short list
➢ Credentials
➢ Feedbacks from clients
➢ Plant visit
● Product quanti cation and forecasting ➔ Based on data gathered
● Budgeting
➔ Work within the budget
A. Planning
B. Implementation
C. Monitoring and Evaluation phase
A
● Product specification
➔ Must be available for all products;
➔ Must include minimum regulatory requirements;
- Supplies should have Certi cate of
Product Registration issued by the FDA.
➔ Financial and legal capacity to supply laboratory
products;
➔ And ability to establish enforceable service and
maintenance contracts.
● Bidding
➔ Open Vs. Limited Sourcing
● Vendor selection
➔ Pre-selection of suppliers, manufacturing
standards.
● Bid solicitation
➔ Formulate solicitation method such as:
1. Invitations to Bid (ITBs)
2. Request for Quotations (RFQs)
● Bid evaluation
➔ Well-de ned transparent process for evaluating
supplier bids.
● Bid award
➔ Issue a purchase order and develop contracts nor long-term agreements.
A. Planning
B. Implementation
C. Monitoring and Evaluation phase
B
MONITORING AND EVALUATION PHASE
Assess supplier performance in relation
to the product delivery pricing, and
customer service.
Monitor supplier performance
MONITORING AND EVALUATION PHASE
Establish system for continuous monitoring of product quality that may utilize or combine lot quality testing and end user feedback.
Post-market surveillance
pa-study nalang ng general clinical lab
thx
time constraint
Is a set of step-by-step instructions compiled by an organization to help workers carry out complex routine operations, aimed to achieve efficiency, quality output and uniformity of performance.
DEVELOP STANDARD OPERATING PROCEDURES (SOP)
MATCH STANDARD OPERATING PROCEDURES (SOP) FORMAT
- For routine procedures that are short and easy to follow; Numbered or bulleted list with short, simple sentences that are clear and easy for the reader
to follow. - For mapping out and plan procedures that include many possible outcomes; good choice when the results are not always predictable
- Used if procedures have a lot of steps that involve some decision; Either bulleted or numbered list or main steps followed by a set of specific substeps.
A. Flowchart format
B. Simple steps format
C. Hierarchical steps format
BAC
All are quality of improvements except:
A. IQAP
B. EQAP
C. Periodic Assessment by Top Management
D. CQIs
E. NOTA
E
