CLASSIFICATION OF CLINICAL LABORATORIES Flashcards
BY OWNERSHIP
Government
Private
National or local government
Government
Individual, corporation, association, or organization
Private
By institutional character
Institution based laboratory
Non institutional based laboratory
Within the premises or part of a DOH licensed health facility
Institutions based laboratory
Operates independently
Non institutional based laboratory
By function
Clinical chemistry, clinical microscopy, toxicology , TDM, immunology and serology, hematology, coagulation, bacteriology, parasitology , mycology and virology
Clinical pathology
Surgical pathology, cytopathology, immunohistochemical techniques and autopsies and forensic pathology
Anatomical pathology
Analysis of certain genes, proteins and other molecules based on the principles, techniques and tools of molecular biology
Molecular pathology
By service capability
A. CLINICAL LABORATORY FOR CLINICAL AND ANATOMICAL PATHOLOGY
PRIMARY
SECONDARY
TERTIARY
LIMITED
UA, FA, FOBT, Pregnancy test (LFA), Wet smear for Trichomonas, FBS/RBS, OGTT, Lipid profile, BUN, Creatinine, BUA, CBC, Blood grouping (ABO and Rh), Rapid tests (Dengue, Syphilis, Hepatitis B screening, HIV screening), TB (DSSM or NAAT for government facilities)
PRIMARY
Primary services plus Serum electrolytes, ALT, AST, Tertiary *Coagulation (PT, APTT), Gram stain, KOH, Pap smear
SECONDARY
Secondary services plus Other Chemistry tests, *ABG, Machine-based serological tests (e.g. tumor markers, thyroid function tests, hepatitis profile), *Cytology and histopathology
TERTIARY
1 or 2 Specialized tests not classified under Anatomic or Molecular Pathology e.g. Hormones, trace metals, tumor markers, allergy panel
DOH program-related tests e.g. Kato-Katz for schistosomiasis, malarial smear, filaria smear, slit-skin smear, RPR for syphilis
LIMITED
PRIMARY
_ WITHOUT MICRO
_ for government facilities
8
9
SECONDARY no. Of personal
12
Tertiary
_ without histopath
_ for hospital based
12
13
CL FOR ANATOMIC PATHOLOGY ONLY
Cytology and histopathology
CL FOR MOLECULAR PATHOLOGY ONLY
Genetics. Immune/hema to pathology and infectious diseases
Shall be required for construction of new CL and for renovation or expansion of existing CL
Permit to construct
Shall secures from the DOH regulatory office. HESRB / CHO with validity of _ year
License to operate
1
Cls that are operated and maintained exclusively for research and teaching purposes shall be required to register every _ years
3 years
The DOH-designated NRL shall be covered by the license of the CL of the hospital where they are affiliated with (consistent with ____)
ONE STOP SHOP LICENSING SYSTEM
____shall not perform any testing beyond its authorized service capability but may be allowed to offer laboratory services other than the respective stipulated minimum services, such as•
but not limited to, MCL, SCL, confirmatory testing for G6PD deficiency, and rHIVda ( CrCL)
DOH LICENSED CL
laboratory testing unit capable of performing limit a diagnostic
confirmatory Lab procedures; moves from one site to another and has a DOH-licensed CL as its main laboratory; allowed to operate at a maximum of __km radius, from the DOH-licensed CL.
MOBILE CLINICAL LABORATORY
extension of the main CL located within the facility’s compound or premises; shall have the same service capability as the main laboratory.
SATELLITE CLINICAL LABORATORY
doctor’s office/clinic wherein CL examinations are performed for the purpose of monitoring the doctor’s patients only and no official results are issued
PHYSICIANS OFFICE LABORATORY
highest level of laboratory in the country performing highly complex procedures and is the responsible entity for facilitating EQAP (NEQAS) to ensure compliance to quality standards for regulation and licensing of all laboratories in the Philippines.
NATIONAL REFERENCE LABORATORY
LICENSING STANDARDS FOR CLINICAL LABORATORY
A. PERSONNEL
B. Quality improvement
C. Information management
D. Environmental Management
Head of the Laboratory - shall visit ——- and at least ——-of supervisory calls and/or videoconferencing OR at least ——- physical visit. For hospital-based CL, it shall be ——-physical visit.
once a month
twice a week
once a week
once a week
——— number shall depend on the workload and the services being provided; should include a designated——— and ——-
REGISTERED MEDICAL TECHNOLOGIST
BIOSAFETY AND BIOSECURITY OFFICER
Laboratory technician, laboratory aide, encoders and receptionist when applicable
Support staff
If applicable
POCT coordinator
Own set of RMTs and support staff
MCL personnel
Internal Quality Assurance Program which shall include:
• ———- for technical procedures.
• ———— for inputs, processes, and outputs.
• ———covering all aspects of laboratory performance.
Internal QC Program
Internal QA Program
CQI Program
administered by a designated NRL or other local and international EQAP approved by the DOH.
External Quality assessment program
INFORMATION MANAGEMENT
. Laboratory reports - shall bear the ——— of the RMTs who performed the laboratory examinations, and the
pathologists who shall be accountable for the reliability of the results.
name , PRC no. and original signature
shall be permitted only if properly authenticated by the
————and shall be in accordance with the provisions of
RA 8792 or the ———-
-Use of digital signature
-Philippine National Public Key Infrastructure
-E - commerce Act
D. ENVIRONMENTAL MANAGEMENT
1. Procedures for proper disposal of infectious wastes and toxic and hazardous substances in accordance with —-/ RA 6969 and other related policy guidelines and/or issuances.
2. Policy for —— and ——
3. Policy guidelines on —- and —-
-Toxic Substances and Hazardous and Nuclear Wastes Control Act of 1990
- biosafety and biosecurity
-infection prevention and control.
RA 10173
DATA PRIVACY ACT OF 2012
Change in the ownership, location, and head of the laboratory or laboratory personnel without
informing the HFSRB/CHD-RLED; and, within
15 days
—— created the National Reference Laboratories; repealed by ——— - Institutionalizing and Strengthening the National Reference Laboratories in the Philippines
DO 393-E s. 2000
DO 820 s. 2020
Microbiology and Parasitology:
Antimicrobial Resistance, Tuberculosis, TTs, Dengue and Other Arboviruses, Influenza and Other Respiratory Viruses, Emerging and Re-Emerging Bacterial Diseases, Leptospirosis, Special Pathogens, Mosquito Vectors of Human Diseases, Malaria and Other Parasites, Schistosomiasis, Rabies and other Lyssaviruses, Polio and other Enteroviruses, Measles and other Exanthems, Invasive Bacterial Vaccine Preventable Diseases, Bacterial Enteric Diseases, Mycology, Rotavirus and other Enteric Viruses
RITM
HIV/AIDS, Hepatitis B and C, Syphilis and STDs
SAN LAZARO HOSPITAL
Environmental and Occupational Health, Toxicology ( drug testing), Micronutrient assay ( water analysis)
EAMC
Hematology, Immunohematology, Immunopathology, Automated Urinalysis, Anatomic Pathology for Renal Diseases, Cellular-Based Product Testing
NKTI
Clinical Chemistry, Anatomic Pathology for Pulmonary and Pleural Diseases
LUNG CENTER OF THE PH
Anatomic pathology for cardiac diseases, Cardiac Markers
Philippine heart center
Mandatory Reporting of Notifiable Diseases and Health Events of Public health concern Act
RA 11332
For COVID-19 laboratories performing rRT-PCR, the minimum number is
7 -includes:
1 Board-certified Clinical Pathologist
3 Analysts - either 3 RMs or 2 RMs and any allied health professional with knowledge, experience, and skills in molecular biology techniques
1 Laboratory Aide,
1 Receptionist
1 Encoder
For COVID-19 laboratories using the cartridge-based technology, the minimum number is
4 - includes :
1 Board Certified Clinical Pathologist;
1 RMT as Analysts per 8 hour shift for every 2 machines;
1 Laboratory Aide per 8 hour shift for every 4 machines;
1 Full-time Encoder per 8 hour shift for every 4 machines.
The laboratory staff shall:
• have trainings on the Fundamentals of ————-
• undergo fit testing for respirator with at ———
• have an annual medical examination including ——-
-Biosafety and Biosecurity and Molecular Diagnostics
-least 95% efficiency e.g. N95 mask
-influenza vaccination
QUALITY IMPROVEMENT ACTIVITIES
COVID-19 testing laboratories shall establish and maintain a system for continuous quality improvement activities and be able to pass in the —-given by ——
NEQAS
RITM
Every COVID-19 testing laboratory shall maintain a system of communication, recording, reporting, and releasing of the patient’s results, in adherence to the Data Privacy Act of 2012 (RA 10173) and the Mandatory Reporting of Notifiable Diseases and Health Events of Public Health Concern Act (RA|1332_)
INFORMATION MANAGEMENT
RELEASE OF RESULTS
Results shall be signed by the——-
who performed the test, verified by a—— and approved by the ——-
prior to release.
-Medical technologist
-Senior MT
-PathOlOGIsT
VALIDITY OF DOH-LTO
•The DOH-LTO, for both hospital-based and non-hospital-based COVID-19 testing laboratory, shall be valid for
1 year
RA 7719
National blood services Act
An Act Promoting Voluntary Blood Donation, Providing for an Adequate Supply of Safe Blood, Regulating Blood Banks, and Providing Penalties for Violation Thereof
RA 7719
- one who donates blood on one’s own volition or initiative and without monetary compensation
VOLUNTARY NLOOD DONOR
blood donor - an individual included in the list of qualified voluntary blood donors who
is ready to donate blood when needed in his/her community.
WALKING BLOOD DONOR
Blood transfusion transmissible diseases - diseases which may be transmitted as a result of blood transfusion, including
AIDS
HEPATITIS B AND C
MALARIA
SYPHILIS
Phase-out of ——– over a period of 2 years after the effectivity of this Act
commercial blood banks
All BSFs shall operate on a non-profit basis but may collect service fees not greater than the maximum prescribed by DOH which shall be limited to the expenses entailed in collecting and processing of blood.
Non profit operation
Rules and regulations to be promulgated by the secretary of health within —- days
60 days
AO 2008-0008
RULES AND REGULATIONS GOVERNING THE REGULATION OF BLOOS SERVICES FACILITIES
-Provision of whole blood and packed red cells;
-Storage, issuance, transport and distribution of whole blood and packed red cells;
-Compatibility testing of red cell units
BLOOD STATION
-Recruitment,
retention, and care of donors;
-Screening and selection of donors;
-Conduct of health education and counseling services;
-Collection of blood from donors;
-Transport of blood to
BC for testing and processing;
• Compatibility testing of red cell units.
BLOOD COLLECTION UNIT
-Storage and issuance of whole blood and blood components obtained from a BC;
-Compatibility testing of red cell units;
-Direct Coombs Test;
-Red cell antibody A screening;
-Investigation of the transfusion reactions -Assist the HBTC in the conduct of post-transfusion (Hemo vigilance) surveillance
BLOOD BANK
-Recruitment, retention and care of donors;
-Conduct health education and counseling;
-Collection of blood from donors;
-Processing and provision of blood components;
-Storage, issuance, transport and distribution of units of whole blood and/or blood products.
-Testing of units of blood for TTIs
Blood center
LTO/ ATO shall be valid for a period of—— years. As part of the hospital license to operate (0SSLS) , the LTO/ATO shall be valid for a period of ——
3 years
1 year
REVISED RULES AND REGULATIONS GOVERNING THE ACCREDITATION OF LABORATORIES FOR DRINKING WATER ANALYSIS
AO 2020-0031
Technical requirements
Minimum workspace
Personnel
Certificate of accreditation
Minimum requirements
Classification A
20m ^2
Minimum Requirements
Classification B
50^2
Minimum requirements
Classification C
70m^2
Personnel
• ——- - competent and experienced professional, with a specialized skill set related to and proportionate to the laboratory category
Head
Personnel
——- must be trained by the NRL for EOHTM
Analysts
PERSONNEL
MICROBIOLOGICAL
REGISTERED MEDICAL TECHNOLOGIST/ CERTIFIED MICROBIOLOGIST/ REGISTERED FOOD TECHNOLOGIST
PERSONNEL PHYSICO-CHEMICAL
REGISTERED CHEMIST/ REGISTERED CHEMICAL TECHNICIAN UNDER SUPERVISION OF A RCHEM
Certificate of accreditation is valid for —— except for institution based LDWA
3 years
AO 2017-0010
PHILIPPINE NATIONAL STANDARDS FOR DRINKING WATER
• When E. coli/Thermotolerant coliform is present in water, a sanitary survey shall be conducted within ———hrs
to determine the cause of contamination which include resampling. If resampled water still contains E. coli/Thermotolerant coliform, corrective actions should be applied and the drinking water service provider shall issue an advisory to ———
24hrs
to boil water or use other household water treatment options, or provide an alternative drinking-water supply
Multiple Tube Fermentation Technique (MTFT):———
Enzyme Substrate Test (EST): ——— Membrane Filter Technique (MFT): ——-
Heterotrophic Plate Count (HPC):——-
<1.1 MPN/100 mL
Absent or <1 MPN/100 mL;
<1 coliform colonies/100 mL
<500 CFU/mL)
