CLASSIFICATION OF CLINICAL LABORATORIES Flashcards by Channel Emz

BY OWNERSHIP

Government
Private

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National or local government

Government

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Individual, corporation, association, or organization

Private

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By institutional character

Institution based laboratory
Non institutional based laboratory

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Within the premises or part of a DOH licensed health facility

Institutions based laboratory

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Operates independently

Non institutional based laboratory

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By function

Clinical chemistry, clinical microscopy, toxicology , TDM, immunology and serology, hematology, coagulation, bacteriology, parasitology , mycology and virology

Clinical pathology

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Surgical pathology, cytopathology, immunohistochemical techniques and autopsies and forensic pathology

Anatomical pathology

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Analysis of certain genes, proteins and other molecules based on the principles, techniques and tools of molecular biology

Molecular pathology

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By service capability
A. CLINICAL LABORATORY FOR CLINICAL AND ANATOMICAL PATHOLOGY

PRIMARY
SECONDARY
TERTIARY
LIMITED

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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

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Primary services plus Serum electrolytes, ALT, AST, Tertiary *Coagulation (PT, APTT), Gram stain, KOH, Pap smear

SECONDARY

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Secondary services plus Other Chemistry tests, *ABG, Machine-based serological tests (e.g. tumor markers, thyroid function tests, hepatitis profile), *Cytology and histopathology

TERTIARY

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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

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PRIMARY

_ WITHOUT MICRO
_ for government facilities

8
9

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SECONDARY no. Of personal

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Tertiary

_ without histopath
_ for hospital based

12
13

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CL FOR ANATOMIC PATHOLOGY ONLY

Cytology and histopathology

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CL FOR MOLECULAR PATHOLOGY ONLY

Genetics. Immune/hema to pathology and infectious diseases

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Shall be required for construction of new CL and for renovation or expansion of existing CL

Permit to construct

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Shall secures from the DOH regulatory office. HESRB / CHO with validity of _ year

License to operate
1

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Cls that are operated and maintained exclusively for research and teaching purposes shall be required to register every _ years

3 years

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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

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____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

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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)

CLASSIFICATION OF CLINICAL LABORATORIES Flashcards

(83 cards)