PMLS MODULE 3 Flashcards
Largest and oldest pathology and laboratory medicine society in the world
- American Society for Clinical Pathology (ASCP)
ASCP Board of Certification (BOC)
Offers a formal process for international laboratory professionals to earn ASCPi credential
Certification for ASCP
International Medical Laboratory Scientist/ MLS (ASCPi)
Eligibility for Examination
a. Route 1
o Baccalaureate degree in MLS, Biological Science, or Chemistry from an accredited educational institution
o Successful completion of MLS training program (Internship) including:
BB (Immunohematology)
Chemistry
Hematology
Microbiology
b. Route 2
o Baccalaureate degree in MLS, Biological Science, or Chemistry from an accredited educational institution
o 3 years clinical lab experience in an accredited lab including:
BB (Immunohematology)
Chemistry
Hematology
Microbiology
c. Route 3
o Baccalaureate degree from an accredited educational institution
o Successful completion of a minimum 2-year MLS program including:
BB (Immunohematology)
Chemistry
Hematology
Microbiology
d. Route 4
o Baccalaureate degree in any Biological Science or Chemistry from an accredited educational institution
o 5 years clinical lab experience in an accredited lab including
BB (Immunohematology)
Chemistry
Hematology
Microbiology
e. Route 5
o Baccalaureate degree from an accredited educational institution
o Minimum 2-year diploma or equivalent in any biological science or chemistry from an approved educational institution
o 5 years of clinical lab experience in an accredited lab including
BB (Immunohematology)
Chemistry
Hematology
Microbiology
Route 1
o Baccalaureate degree in MLS, Biological Science, or Chemistry from an accredited educational institution
o Successful completion of MLS training program (Internship) including:
BB (Immunohematology)
Chemistry
Hematology
Microbiology
o Baccalaureate degree in MLS, Biological Science, or Chemistry from an accredited educational institution
o 3 years clinical lab experience in an accredited lab including:
BB (Immunohematology)
Chemistry
Hematology
Microbiology
Route 2
Route 2
o Baccalaureate degree in MLS, Biological Science, or Chemistry from an accredited educational institution
o 3 years clinical lab experience in an accredited lab including:
BB (Immunohematology)
Chemistry
Hematology
Microbiology
Route 3
o Baccalaureate degree from an accredited educational institution
o Successful completion of a minimum 2-year MLS program including:
BB (Immunohematology)
Chemistry
Hematology
Microbiology
Route 4
o Baccalaureate degree in any Biological Science or Chemistry from an accredited educational institution
o 5 years clinical lab experience in an accredited lab including
BB (Immunohematology)
Chemistry
Hematology
Microbiology
Route 5
o Baccalaureate degree from an accredited educational institution
o Minimum 2-year diploma or equivalent in any biological science or chemistry from an approved educational institution
o 5 years of clinical lab experience in an accredited lab including
BB (Immunohematology)
Chemistry
Hematology
Microbiology
Application Fee for ASCP
$200 for MLS (August 2019)
• Non-refundable, credit card or check through mail
Examination Appointment
Pearson Virtual University Enterprises (VUE)
Pearson VUE
Delivers certification exams for the ASCP Board of Certifications
Testing for ASCP
• Unit 401 Don A. Gothong Centre (Sugbutel), Sergio Osmena Boulevard, North Reclamation Area, Cebu City
• Unit 2201, Antel Corporate 2000 Centre, 121 Valero Street, Salcedo Village, Makati City, Manila
• 27th Floor, Trident Tower, 312 Senator Gil Puyat Avenue, Makati City, Manila
May schedule the exam date and time at a Pearson VUE within _______
3 monhs (you can choose the date)
Examination Administration of ASCP
Computer Adaptive Testing
Computer Adaptive Testing (CAT)
- Answering a question correctly, the next test question has a slightly higher level of difficulty
- Answering a question incorrectly, the next test question has a slightly easier level of difficulty
- Tailored to individual’s ability level
- Must answer enough difficult questions to achieve a score above the pass point to pass the certification examination
Standard Examination of ASCP
100 MCQ, 2 hours and 30 minutes
Criteria to Pass in ASCP
• Raw scores translated to ‘scaled score’
• Scaled scores derived from raw score
• 0 – 999
• Compared the same scale even taken a different examination
• 400 scaled score to pass the exam
ASCP: How many points to pass the exam
400 scaled score
Examination Score ASCP
• Preliminary results (PASS/FAIL) will appear on the screen
• Email will be sent within 4 business days
• Official score result indicate pass or fail status and the scaled score on the exam
• If failed, scaled score on each subtests will also be indicated
ASCP: Reapplying for Examination
• Can take the exam 5 times per route
• If fail, take an alternate route
• If you do not meet the requirements under an alternate route of eligibility, you will no longer be eligible to apply for that examination category.
ASCP: Initial Certification
MLS (ASCPi)
ASCP: Examination Content
Subtests:
BB - 17-22%
UA(o)BF - 5-10%
Chemistry - 17-22%
Hematology - 17-22%
Immunology - 5-10%
Microbiology - 17-22%
ASCP: Certification Expiration
• ASCPi certifications prior to January 1, 2012, were awarded certification with no expiration date
• ASCPi certified individuals beginning January 1, 2012: 3 years validity
ASCP: Maintain Validity
participation in the Credential Maintenance Program (CMP) is required.
Required CMP points
o Required CMP points for International MLS and International MLT: 36 points
ASCP: Point distribution
• 1 point in laboratory or patient safety (i.e., quality control, quality assurance)
• 2 points in each of the following: blood banking, chemistry, hematology, microbiology
• Remaining points in area(s) of lab specialty, immunology, molecular diagnostics, management, education, or other related laboratory areas of interest
CMP points can be acquired via:
• Formal continuing education courses, employer-offered courses, college/ university coursework, employer assessment, clinical teaching, research and presentation or workshop, authorship of published journals and books, master’s thesis
CMP Application Fee
$95
ASCP: Expired certificates
• For those with expired certificates who are seeking reinstatement, they must pay both the CMP Application Fee and the CMP Reinstatement Fee of $125
ASCP: Fees
• CMP Application Fee of $95
• For those with expired certificates who are seeking reinstatement, they must pay both the CMP Application Fee and the CMP Reinstatement Fee of $125
• The designation ‘CM’ as a superscript is required after certification initials to indicate that you have successfully maintained your certification
Title after successful maintenance certification:
MLS(ASCPi)CM
American Medical Technolgists
National Agency that certifies examination-based primary designations of healthcare personnel
AMT: Certification
Medical Technologist (MT)
AMT: Application Fee
180% for MT (August 2019)
AMT: Testing Center
Pearson VUE delivers examinations for the AMT (Same Philippine testing centers with that of the ASCP exams)
• Unit 401 Don A. Gothong Centre (Sugbutel), Sergio Osmena Boulevard, North Reclamation Area, Cebu City
• Unit 2201, Antel Corporate 2000 Centre, 121 Valero Street, Salcedo Village, Makati City, Manila
• 27th Floor, Trident Tower, 312 Senator Gil Puyat Avenue, Makati City, Manila
AMT: Examination Administration (Standard Examination)
Computer-based testing
Time limit: 3.5 hours
200-230 MCQ
AMT: Examination Content
General Laboratory - 12%
Clinical Chemistry - 19%
Hematology - 13%
Coagulation and Homeostasis - 7%
Immunology and Serology - 9%
Immunohematology- 10%
Blood Banking and Transfusion Services - 6%
Microbiology - 15%
UABF - 9%
AMT: Criteria to Pass
• Raw scores are converted to “Scaled Scores” ranging from 0 to 100
o Provide a common scale for reviewing test results across examinees, and across different forms of the same test
o Scores that examinees receive, are neither percentages of questions, nor numbers of questions answered correctly. Rather, these are points on a 0 to 100 scale
• Minimum scaled score of 70 to pass the exams
AMT Minimum scaled score to pass
70 points
AMT: Retesting
Candidates can take the exam up to a maximum of four times
AMT: Annual Renewal Fee
90$
Certification Continuation Program
• Requires certified members to document activities supporting continuing education (CE) every 3 years as well as pay an annual fee to keep their status active
• For every 3 years, one must pay the annual fee and obtain 45 CE points (every 3 years)
AMT: Points
45 CE Points (every 3 years)
CE points can be earned through
Professional Education, Formal Education, Employment Verification, Authorship of Written Work, Instructional Presentation, Organizational Participation & AMT Online Continuing Education
THE CLINICAL LABORATORY
DOH A.O. 2007-0027
Presented the revised rules and regulations governing the licensure and regulation of clinical laboratories in the Philippines
Definition of Terms
Clinical Laboratory
Routine Testing
STAT Testing
Critical Values
Clinical laboratory
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 diseases.
Provide consultative advisory services covering all aspects of laboratory investigation including the interpretation of results and advice on further appropriate investigation
Include areas that are involved in the collection, handling, and or preparation of specimens and those that act as mailing or distribution centers
Routine Testing
• Basic, commonly requested tests in the laboratory, the results of which are not required to be released immediately upon completion.
• Follow the usual procedures and system in the laboratory
Stat Tests
• Abbreviation for sta’tim (immediately)
• Tests done on urgent cases, the result of which shall be released immediately, within one (1) hour after the procedure
Critical Values
Lundberg: “life-threatening” unless something is done promptly and for which some corrective action could be undertaken
Classification of Clinical Laboratories
Ownership, Function, Instituitional Character, Service Capability
Ownership
Government-
Operated and maintained, partially or wholly, by the national government, a local government unit, any other political unit or any department, division, board, or agency
Private-
Owned, established, and operated by any individual, corporation, association, or organization
Function
Clinical Pathology- Clinical Chemistry, Hematology, Immunohematology, Microbiology, Immunology, Clinical Microscopy, Endocrinology, Molecular Biology, Cytogenetics, Toxicology, TDM
Anatomic Pathology-
Surgical Pathology, Immunohistopathology, Cytology, Autopsy, Forensic Pathology, Molecular Pathology
Institutional Character
• Institution Based
A laboratory that operates within the premises and as part of an institution, but not limited to hospital, medical clinic, school, medical facility for overseas workers and seafarers, birthing home, psychiatric facility, drug rehabilitation center
• Freestanding
A laboratory that does not form part of any other institution
Service Capability
General Clinical Laboratory
Special Clinical Laboratory
GCL: Primary Category
Minimum Technical Working Area of 10 square meters (DM No. 148 s.2003)
a. Routine Hematology
i. Hemoglobin Mass Concentration
ii. Erythrocyte Volume Fraction (Hematocrit)
iii. Leukocyte Number Concentration (WBC count)
iv. Leukocyte Type Number Fraction (Differential count)
b. Qualitative platelet determination
c. c. Routine urinalysis
d. d. Routine fecalysis
e. e. Blood typing (hospital-based laboratories)
GCL: Secondary Category
Minimum technical working area of 20 square meters (as per DM No. 148 s.2003)
Test offered:
a. Services offered by primary laboratory
b. Routine Chemistry
i. Blood glucose substance concentration
ii. Blood urea nitrogen concentration
iii. Blood uric acid substance concentration
iv. Blood creatinine concentration
v. Blood total cholesterol concentration
c. Quantitative platelet determination
d. For Hospital-based laboratories:
o Cross-matching
o Gram staining
o KOH preparation
Tertiary Category
Minimum technical working area of 60 square meters (as per DM No. 148 s.2003)
Test offered:
a. Services offered by secondary laboratory
b. Special Chemistry
c. Special Hematology, including coagulation procedures
d. Immunology
e. Microbiology- Culture and Sensitivity (C&S):
o Hospital based: Aerobic AND anaerobic C&S
o Non-hospital based: Aerobic OR anaerobic C&S
Limited Services Capability
(Institution-based only)
Provides the laboratory tests required for a particular service in institutions
Labs in dialysis center and hygiene clinics
Special Clinical Laboratory
Laboratory that offers highly specialized laboratory services that are usually not provided by a general clinical laboratory
a. Assisted reproduction technology laboratories
b. Molecular and cellular technology
c. Molecular Biology
d. Molecular Pathology
e. Forensic Pathology
f. Anatomic Pathology
National Reference Laboratories
• A laboratory designated by the DOH to provide special functions and services for specific disease areas
Function of NRL
a. Provision of referral services
o Confirmatory testing
o Surveillance
o Resolution of conflicting results between or among laboratories
b. Training
c. Research
d. Evaluation of diagnostic kits and reagents
e. Implementation of EQAP or NEQAS
External Quality Assurance Program (EQAP) or National External Quality Assurance Scheme (NEQAS)
• Laboratories are given unknown samples for analysis. The said samples are to be tested via the laboratory’s usual processing and examination
• Quality of performance is evaluated using closeness of results to the pre-determined value or to the reference value generated by the participating laboratories through peer group analysis
Different NRLS in the Philippines
East Avenue Medical Center
Lung Center of the Philippines
San Lazaro Hospital STD AIDS Cooperative Center Laboratory (SLH SACCL)
National Kidney & Transplant Institute
Research Institute for Tropical Medicine
Philippine Heart Center
East Avenue Medical Center
Environmental Health, Occupational Health, Toxicology, Micronutrient Assay
Lung Center of the Philippines
Clinical Chemistry
San Lazaro Hospital STD AIDS Cooperative Center Laboratory
HIV/AIDS and other Sexually Transmitted Infections
National Kidney & Transplant Institute
Hematology, Immunohematology, Immunopathology, Automated Urinalysis, Anatomic Pathology for Renal Diseases
Research Institute for Tropical Medicine
Microbiology, Parasitology
Also, the confirmatory testing laboratory for blood donor units for the National Voluntary Blood Services Program
National External Quality Assurance for Bacteriology, Parasitology, and Mycobacteriology
WHO-recognized National Influenza Center
Philippine Heart Center
Anatomic Pathology for Cardiovascular Disease
The Physician’s Office Laboratory (POL)
• Doctor’s office with a laboratory
• Required to secure a clinical laboratory license when it undertakes any or all the following: *
o Issue official laboratory results
o Perform more than *monitoring examinations
o Cater not only to the physician’s own patients
Satellite Testing Site
• Testing site that performs laboratory examinations under the administrative control of a licensed laboratory, but performs outside the physical confines of that laboratory
• Needs to secure a separate license to operate
Mobile Clinical Laboratories
• Laboratory testing unit that moves around
• Has a base laboratory
• Only to collect specimens
• Allowed to operate within 100 km radius from main laboratory
Point-of-Care Testing (POCT)
• Diagnostic testing at or near the site of patient care rather than in the clinical laboratory
• Includes bedside testing, outpatient, and home care
• If conducted in a hospital: Required to be under the management and supervision of the licensed clinical laboratory of the respective hospital
• Persons performing POCTs are called operators and are usually primary patient providers (phlebotomists, nurses, physicians, respiratory therapists, radiographers, ambulance personnel, medical laboratory scientists, and patients)
Clinical Laboratories Improvement Amendments of 1998 (CLIA ‘88)
CLIA ‘88 regulates the qualifications for health-care personnel authorized to perform POCT
• Clinical Laboratory Improvement Amendments of 1988 (CLIA’88): US amendment to their Public Health Services Act in which Congress revised the federal program for certification and oversight of clinical laboratory testing
• Two subsequent amendments were made after 1988. However, the law continues to be cited as CLIA ’88 as named in legislation.
Waived tests
Characteristics:
• Considered simple to perform and interpret
• The likelihood of erroneous results is negligible; or pose no reasonable risk of harm to the patient if the test is performed incorrectly
• Require no special training or educational background
• Require only minimum quality control
Originally, only _____________ were listed as meeting these criteria in 1988 but have grown to more than _____ today
8 tests, 80