RA 4688 Flashcards by JULIA CASSANDRA RECCION

Implementing Guidelines (Old & Amended)

● Administrative Order No. 201, Series of 1973
● Administrative Order No. 290, Series of 1976
● Administrative Order No. 52, Series of 1983
● Administrative Order No. 49-B, Series of 1988
● Executive Order No. 102, Series of 1999
● Administrative Order No. 59, Series of 2001

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Redirecting the Functions & Operations of DOH

Executive Order No. 102, Series of 1999

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Rules & Regulations Governing The Establishment, Operation & Maintenance of Clinical Laboratories in the Philippines

Administrative Order No. 59, Series of 2001

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Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines

Administrative Order No. 2007-0027

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Amendment to Administrative
Order No. 2007-0027

Administrative Order No. 2007-0027-A

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Posting of Schedule of Fees for Laboratory and Other Diagnostic Services of Hospitals and other Health Facilities

Administrative Order No. 2008-0002

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Specific department of DOH in-charge of licensing and regulation of all health facilities including Clinical Laboratories

Health Facilities & Services Regulatory Bureau

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Schedule of Fees for the Licensure of General Clinical Laboratories and the Registration of Special Clinical Laboratories

Administrative Order No. 2008-0007

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is in charge all clinical laboratory
licensing and related concerns

Health Facilities & Services Regulatory Bureau

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Formerly BHFS (Bureau of Health Facilities & Services)

Health Facilities & Services Regulatory Bureau

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Signed by then DOH Secretary Francisco Duque

AO 2021-0037

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The necessity to review the current AO and to revise and update the minimum standards and technical requirements for licensing clinical laboratories in the Philippines is aligned with the main objective of Republic Act No. 11223 or the Universal Health Care Act which is to guarantee access to quality and affordable
health products, devices, facilities and services

New Rules and Regulation Governing the Regulation of Clinical Laboratories in the Philippines / AO 2021-0037

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Natural or juridical person who intends to operate a clinical laboratory

Applicant

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HFSRB

Health Facilities & Services Regulatory Bureau

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CHD

Center for Health Development

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Facility where tests are done on specimens from human body to obtain information about health status of patient for prevention, diagnosis and treatment of diseases

Clinical Laboratory

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Panic values originally describe by Lunderberg as “life-threatening” unless something is done promptly and for which some corrective action could be undertaken

Critical Values

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DOH

Department of Health

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EQAP

External Quality Assessment Program

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Program where participating laboratories are given unknown samples for analysis

External Quality Assessment Program

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Checklist used by regulatory officers during inspection
visits to evaluate compliance of clinical laboratory to
minimum standards and technical requirements

Assessment Tool

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Assessment Tool for Licensing a General Clinical Laboratory

AO 2021-0037 Annex B1

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Equipment / Instruments / Glassware / Supplies / Reagents per Area of Activity / Service
Capability of General Clinical Laboratory

AO 2021-0037 Annex B2

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Prohibited Acts in the Operations of Clinical Laboratories

AO 2021-0037 Annex C

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Planning and Design Guidelines for General Clinical Laboratory

AO 2021-0037 Annex D2

Checklist for Review of Floor Plans General Clinical Laboratory

AO 2021-0037 Annex D2

Guidelines in Securing for Remote Collection Permit for Clinical Laboratories

AO 2021-0037 Annex E

Application Form for Certificate Of Registration for Research and Teaching Clinical Laboratory

AO 2021-0037 Annex F

Corporate body or establishment organized for an educational, medical, charitable or similar purpose

Institution

Issued by DOH to an individual, agency, partnership or corporation that operates a clinical laboratory upon compliance with the requirements set forth

License

Also refers to the license

License to Operate (LTO)

Individual, agency, partnership or corporation to whom the license is issued and upon whom rests compliance

Licensee

Laboratory testing unit that moves from testing site to another testing site, or has a temporary testing location

Mobile Testing Laboratory

Tests done in series on patients as a guide for treatment or follow-up of their condition

Monitoring Examinations

Laboratory in a government hospital designated by DOH to provide special functions and services for specific disease areas

National Reference Laboratory

NRL for Clinical Chemistry

Lung Center of the Philippines (LCP)

NRL for Hematology, Immunohematology, Urinalysis

National Kidney and Transplant Institute (NKTI)

NRL for Drug Testing, Water Microbiology, Micronutrient Assay

East Avenue Medical Center (EAMC)

NRL for Serology

STD / AIDS Central Cooperative Laboratory (SACCL)

NRL for Microbiology and Parasitology

Research Institute of Tropical Medicine (RITM)

Individual doctor’s office / clinic wherein laboratory examinations are performed

Physician's Office Laboratory / POL

Diagnostic testing at or near the site of patient care rather than in clinical laboratory Includes bedside testing, outpatient and home care

Point of Care Testing (POCT)

Basic, commonly requested tests in the laboratory, the results of which are not required to be released immediately after completion

Routine Tests

Any testing site that performs laboratory examinations under the administrative control of a licensed laboratory, but performed outside the physical confines of that laboratory

Satellite Testing Site

Done on urgent cases, results of which shall be released immediately, within one (1) hour after the procedure

STAT Tests

STAT is an abbreviation for ______ which means immediately

sta'tim

Classification of Laboratories Operated and maintained, partially or wholly, by the national government, a local government unit (provincial, city, or municipal), any other political unit or any department, division, board, or agency thereof

Government

Classification of Laboratories Owned, established and operated by any individual, cooperation, association or organization

Private

T/F: Private and Government clinical laboratories have different functions in the clinical lab.

F; they have the same function

Clinical Pathology includes

1. Clinical Chem 2. Hematology 3. Immunohema 4. Microbio 5. Immunology 7. Clin Microscopy 8. Endocrinology 9. Mol Bio 10. Cytogenetics 11. Toxicology & Therapeutic Drug Monitoring 12. Oth. similar disciplines

A laboratory that does not form part of any other institution

Free-Standing

Anatomic Pathology includes

1. Surgical Pathology 2. Immunohistopathology 3. Cytology 4. Autopsy 5. Forensic Pathology 6. Molecular Pathology SICAFM

A laboratory that operates within premises and as part of an institution, such a but not limited to hospital, medical clinic, school, medical facility for overseas workers and seafarers, birthing home, psychiatry facility, drug rehabilitation center

Institution-based

Specific services only

Limited Service Capability (institution based)

A laboratory that offers highly specialized laboratory services that are usually not provided by a general clinical laboratory

Special Clinical Laboratory

Primary Lab service capabilities

Routine Hema (CBC - Hemog, Hemato, WBC count, WBC diff count) Qualitative Platelet Determination Routine Urina Routine Feca Blood Typing (hosp-based)

Secondary service capabilities

+ primary Routine Clin Chem (Glucose, Blood Urea Nitro, Uric Acid, Creatinine, Total Cholesterol) Quanti Platelet Determination Cross Matching (hosp) Gram Staining (hosp) KOH (hosp)

What labs are exempted from the licensing requirement but shall register?

1. Clinical laboratories exclusive for research and teaching purposes 2. Special Laboratories

Provides laboratory tests required for a particular service in institutions such as but not limited to dialysis centers and social hygiene clinics

Limited Service Capability Lavoratory

Tertiary service capabilities

+ secondary Special Chem Special Hema Immunology Microbiology (Culture Sensi - Aero & Anaero [hosp] Aero/Anaero [non-hosp])

Special labs exempted

○ Assisted Reproduction Technology ○ Molecular & Cellular Technology ○ Molecular Biology ○ Molecular Pathology ○ Forensic Pathology ○ Anatomic Pathology (independent from a clinical laboratory)

(are) required to secure a LTO when it undertakes any or all of the following activities: ○ Issue official laboratory results ○ Perform more than monitoring examinations ○ Cater not only to the physician's own patients

POL / Physician's Office Laboratory

(in hospital) required under management of clinical laboratory

POCT

Shall have administrative and technical supervision of the activities in the laboratory

Pathologist (Head)

Clinical / Anatomic is certified by

Philippine Board of Pathology

New Requirement for Staffing from AO 2021-0037

8 RMTs in the primary lab

Minimum Technical Working Area (DM No. 148 s. 2003) Primary

10 sqm

Minimum Technical Working Area (DM No. 148 s. 2003) Secondary

20 sqm

Minimum Technical Working Area (DM No. 148 s. 2003) Tertiary

60 sqm

Well-ventilated, adequately lighted, clean and safe

Physical Facilities

T/F: In External QC, all laboratory shall participate in EQAS given by designated NRL

Basis for suspension / revocation of license

EQAS-NRL

In reporting, bear the name ad signature of?

Pathologist & RMT

T/F: When reporting, there should be no report orally or in writing without directive from pathologist or associate except in emergency cases

Records are kept in a file for at least?

1 year

T/F: Anatomic & clinical pathology reports are kept permanently.

F; anato & forensic

Under One-Stop-Shop Licensure System for Hospitals

Renewal of LTO

Renewal of LTO date for non-hospital based

First day of October to last day of November

Renewal of LTO is processed not later than _____________ after expiration date of LTO

5 working days

shall conduct announced inspections at any reasonable time

CHD

shall ensure accessibility of premises and facilities for inspection of CHD Director or authorized representative(s) at any reasonable time shall ensure availability of all pertinent records for checking/review of CHD Director or his authorized representative(s)

Licensee

prescribes the standards, criteria and technical requirements for the issuance of LTO, shall be utilized

Inspection Tool

T/F: Inspection is not announced for old (after 1 yr) labs

T/F: Inspection for new (1st time) labs are announced

shall suspend, cancel or revoke and may seek any law enforcement agency to execute the closure of any erring lab when necessary

HFSRB/CHD Director/Rep

Who investigates the complaint?

HFSRB/CHD Director/Rep

Penalties for clinical laboratories in a hospital will be governed by ________, dated _____, titled ______________

AO No. 2007- 0022 June 6, 2007 “Violations under the One-Stop Shop Licensure System (OSSOLS) for Hospitals”

Owned, established and operated with funds through donation, principal, investment or other means by any individual corporation, association or organization

Private

Within the premises or compound of the hospital May be part of general clinical laboratory but with designate

Hospital-based

Located outside the premises or compound of a hospital and independently functioning on its own

Non-hospital based

Minimum number of personnel

7 1 Patho 3 Analysts (3 RMTs / 2 MTs & 1 Allied Health w/ training) 1 Lab Aide 1 Receptionist 1 Encoder

With training in Infectious Disease and Molecular Diagnostics / Infectious Disease Specialist

Pathologist

Reagent Preparation

● PCR cabinet / laminar flow ● 4°C refrigerator for reagents ● -20°C freezer for reagents ● Microcentrifuge ● Vortex mixer ● Minifuge ● Cold rack for PCR tube ● Set of four adjustable-volume micropipettes with rack ○ 100-1000 uL ○ 20-200 uL ○ 2-20 uL ○ 0.5-10 uL ● Micropipette tips ● Gloves in different sizes (S, M, L)

Specimen Preparation

Biological Safety Cabinet Class II Type A2

used to protect personnel, products and the environment from exposure to biohazards and cross contamination during routine procedures.

Biological Safety Cabinets

provide a partial barrier for the safe manipulation of low, moderate and high-risk microorganisms. most frequently used in research and clinical laboratories, are divided into four types (Types A1, A2, B1 and B2).

Class II BSCs

1st Offense

Stern Warning

3rd Offense

P50,000

2nd Offense

P30,000

4 Offenses

Revocation of DOH-LTO

If offender is a firm or corporation, the ________ and/or owner(s) shall be liable to the penalty imposed

managing head

Any person who operates a CL without securing the necessary DOH-PTC and corresponding DOH-LTO shall be issued a Cease-and-Desist Order (CDO) and shall pay the administrative penalty of

P50,000

Amplification / PCR

● Real-time PCR machine ● Conventional PCR machine ● Minifuge ● Computer and printer (associated with the real-time PCR machine) ● -20°C or -40°C freezer for storage of PCR products ● Real-time PCR machine ● Conventional PCR machine

Guidelines in Securing a License to Operate a COVID-19 Testing Laboratory in the Philippines

Administrative Order No. 2020-0014