MT Laws and Bioethics Numericals

Effectivity after publication

15 days

PD 223

RA 4688

RA 6969

RA 7170

RA 7719

RA 8981

RA 9003

RA 9165

RA 9275

RA 9288

RA 9482

RA 10912

RA 10968

RA 11166

RA 11223

RA 11469

RA 11494

PD 223 Creation of PRC

RA 4688 Clinical Laboratory Act of 1966 (June 18)

RA 6969 Toxic Substances, Hazardous Wastes, and Nuclear Waste Control Act of 1990

RA 7170 Organ Donation Act of 1991 (Jan 7, 1992)

RA 7719 National Blood Services Act of 1994 (May 5 ; repealed RA 1517)

RA 8749 The Philippine Clean Air Act of 1999

RA 8981 PRC Modernization Act of 2000 (December 5)

RA 9003 ESWM of 2000

RA 9165 Comprehensive Dangerous Drugs Act of 2002 (June 7) Repealed 6425

RA 9275 Philippine Clean Water Act of 2004 (March 22)

RA 9288 Newborn Screening Act of 2004 (April 7)

RA 9482 Anti Rabies Act of 2007

RA 10912 Continuing Professional Development Act of 2016 (July 21 not signed)

RA 10968 Philippine Qualifications Framework of 2018 (August 20)

RA 11166 Philippine HIV and AIDS Policy Act of 2018 (December 20) repealed 8504

RA 11223 Universal Health Care Act of 2019 (February 20)

RA 11469 Bayanihan to Heal as One of 2020 (March 24)

RA 11494 Bayanihan to Recover as One of 2020 (September 11)

RA 5527

June 21, 1969

32 sections

RA 6138

August 31, 1970

Repealed 16, 21,22

PD 498

June 28,1974

Repealed 2,3,4,7,8,11,13,16,17,21,29

PD 1534

June 21,1978

Repealed 3,8,11,18,

PSG on Medtechs Education

CMO 14 S 2006

PSG on Medtech Program

CMO 13 S 2017

Clinical laboratory Act

RA 4688

June 18,1966

Newest AO for Laboratory Operations

AO 2021-0037

repealed 2007-0027

National Blood Services Act of 1994

RA 7719

May 5,1994

Regulation on Passing Rates

3 yrs consecutive

<30% - Warning. Joint PRC-CHED visitation every year

21-29%- Probation. Joint PRC-CHED visitation every 6 months

<20- Phaseout

Internship duration and hours

1,664 / 32 hours per week for 52 weeks

Committee of Nominations

5 immediate past members of APOs

Composition of PRBMT

Years

1 Chairman 2 Board Members

3 Years

Years of being RMT/Pathologist in PRBMT criteria

10 years

Not a faculty member of schools for

2 years

Disqualification if completed at least __ terms in PRB

2

Guidelines in Accreditation of Clinical Laboratories in Training Interns

CMO 6 S 2008

MTLE testing centers, Months

15, March (weekdays), August (weekends)

Change of schedule must be reported by PRBMT within

30 days

Changes associated with subjects and weights must be reported by PRBMT within

3 months

Report of rating within __ days

10

Signatures of COR

3 from PRBMT and 1 from PRC Chairperson

COR to be surrendered within __ days after decision of PRBMT

30

Appeal to _____within ___ days of receipt of PRBMT decision. If not, it is final.

PRC, 15 days

Maximum duration of suspension

2 years

No of personnel in primary CL

8 without micro

9 for government facilities

No of personnel in secondary CL

12

No of personnel in tertiary CL

12 without histopath

13 for hospital based

LTO duration

1 year

LTO duration for clinical and research purposes

3 years

Mobile Clinical Laboratory distance from the main laboratory

Within 100 km radius

Renewal period for LTO

first week of October until last day of November

Visitation of Pathologist in lab

Once a month and twice a week supervisory calls

Once a week physical visit

If hospital-based, once a week

Who visits and inspects laboratory

HSFRB through CHD

E-commerce act

RA 8792

Disposal in accordance with

RA 6969

Data Privacy Act of ______

2012

RA 10173

If laboratory changes its ownership or name, within how many days should it be reported to HFSRB?

15 days

D. O. that designate the NRLs

D.O. 393-E s. 2000

DO 820 s. 2020

How many NRLs are currently present

6

Personnel for COVID-19 Laboratories performing rRT-PCR

7

1 Clinical Pathologist

3 Analyst

1 Laboratory Aid

1 Receptionist

1 endcoder

Personnel for COVID-19 Laboratories performing cartridge-based technology

4

1 Clinical pathologist

1 analyst 8 hr in 2 machines per shift

1 laboratory aide 8 hr in 4 machines per shift

1 encoder 8 hr in 4 machines per shift

RA for mandatory reporting of notifiable diseases

RA 11332

Validity of COVID-19 DOH-LTO

1 year

National Blood Services Act of 1994

RA 7719

May 5,1994

Phasing out of commercial blood banks upon effectivity of RA 7719 AIS is within

2 years

AO related to RA 7719

AO 2008-0008

LTO of Blood Service Facility

LTO of Blood Service Facility under OSSLS

3 years

1 year

DOH AO 57 s 1989

Blood banks must be headed by

DOH AO 118-A

hematologist and pathologist

National Blood Services Program

AO for accrediting Laboratories for Water Analysis

AO 2020-0031

Minimum workspace for Water Analysis Lab by classes

Class A - 20mm2

Class B - 50 mm2

Class C - 70mm2

Duration of Certificate of Accreditation of Water Analysis

3 years

Philippine National Standards for Drinking Water

AO 2017-0010

Standard values for Drinking water

Multiple Tube Fermentation Test (MTFT) :

Enzyme Substrate Rest (EST) :

Membrane Filtration Technique (MFT) :

Heterotrophic Plate Count (HPC) :

Multiple Tube Fermentation Test (MTFT) : <1.1 MPN/100 mL

Enzyme Substrate Rest (EST) : <1 MPN/100 mL

Membrane Filtration Technique (MFT) : <1 colony coliform/100 mL

Heterotrophic Plate Count (HPC) : <500 CFU/mL

When thermo tolerant E coli is present, sanitary survey must be done within _________

24 hours

5 Service Capabilities of Water Ana Laboratories

1. Bacteriological- coliforms

2. Biological- plankton

3. Physical- aesthetic

4. Chemical - trace elements

5. Radiological

Registration of Water Ana Lab is in what agency

HSFRB

Mandatory parameters for Water Ana

Cadmium

Lead

Arsenic

Nitrate

Color

Turbidity

pH

Thermotolerant E coli

Total dissolved solids

Disinfectant residual

Water Ana

Head of Free standing:

Head of Lab-based:

4 Qualified Analysts:

Head of Free standing: Sanitary engineer

Head of Lab-based: Clinical Pathologist

4 Qualified Analysts:

RMT - Microbio

Chemist- Physicochemical

Pharmacist - Microbio

Microbiologist- Microbio

Comprehensive Dangerous Drugs Act of 2002

RA 9165

JUNE 7 2022

Repealed RA 6425

Guidelines in doing IDTOMIS

AO 2008-0025

IDTOMIS-Integrated Drug Testing Operations Management Information System

Dimensions of DTL Floor and Work Area

Screening:

Confirmatory:

Screening:

Work Area- 10 mm2

Floor Area- 20 mm2

Confirmatory:

Work Area- 30 mm2

Floor Area- 60 mm2

Headship of DTI

Freestanding SL: Physician licensed with PSP in AP

Institution based SL: (5)

Confirmatory DTL: (2)

Freestanding SL:

Institution based SL: Physician, Chemist, Chem Eng, Medtech, Pharmacist

Confirmatory DTL: Physician (2 years in toxicology), Chemist (with Masters and 2 years anachem)

4 Qualified Drug analyst

Screening:

Chemist, Med Tech, Chem Eng, Pharmacist

Confirmatory:

Chemist AND Med Tech, Chem Eng or Pharmacist

6 specimens for DT

Urine (at least 60 mL)

Blood

Fingernails and Hair (long term exposure)

Saliva

Sweat (patch)

Tissue

2 random drug tests performed on

Students of secondary and tertiary schools

Employees from public and private offices, overseas or domestic

Act that abolished mandatory drug testing for driver's license application

RA 10586

Anti-Drunk and Drugged Driving Act of 2013

Positive Drug test can be challenged within

15 days

Maximum number of DT laboratories a clinical pathologist can handle within __ km radius is ___

5; 10

Personnel of SL and CL

SL (3)- Head, Analyst, Authorized Specimen Collector

CL (2)- Head, Analyst,

A drug testing specimen can be kept for __

1 year

Validity of drug testing result

1 year

LTO duration of SL and CL

SL: 1 year

CL: 2 year

5 panel drug test

TOPAC

THC

Opiates

Phencyclidine (PCP)

Amphetamines

Cocaine

Philippine HIV and AIDS Policy Act of 2018

RA 11166

December 20, 2018

Repealed RA 8504

Policies and Guidelines inn HIV testing Services

AO 2017-0019

Recommended screening frequency for key populations

every 3 months

Key population:

Male having sex with male

Drug injectors

Prisoners

Sex workers

Transgenders

Recommended screening frequency for pregnant women or PLHIV partner

once every trimester and once after breastfeeding

Recommended screening frequency for PARTNERS of a Key Population Person

Annual

Implementing Rules and Regulation of PNAC

PNAC resolution 1 s. 2019

Consent not needed for (2) age groups with corresponding doctrines

15-<18: Evolving capacities of child doctrine

<15: Mature minor doctrine (pregnant, highrisk)

Cybercrime Protection Act of 2012

RA 10175

+2 lang from Data Privacy Act

Old algorithm for HIV testing

(+) screening from non-crCL

2 parallel screening tests + supplementary Western Blot (if reactive on parallel screening)

These are all done in SACCL

AO for guidelines of rHIVda (New Algorithm)

AO 2019-0001

New Algorithm for HIV testing

T0 reactive

Perform rHIVda 1 (T1)

Reactive: Perform rHIVda 2

Nonreactive: repeat after 2-6 weeks

Perform rHIVda 2 (T2)

Reactive: Perfrom rHIVda 3

Nonreactive: Report as INCONCLUSIVE ; repeat after 2-6 weeks ; Send sample in SACCL

Perform rHIVda 3 (T3)

Reactive: Report as HIV positive

Nonreactive: Report as INCONCLUSIVE ; repeat after 2-6 weeks ; Send sample in SACCL

Designation of (+) HIV test from non-certified clinical laboratory (non-crCL)

T0

Penalty of knowingly infecting someone with HIV

Penalty of breaching confidentiality

6-12 years

6 months to 2 years/ 50K - 150K

Newborn Screening Act of 2004

RA 9288

April 7, 2004

AO for adding MSUD

AO for Expanded NBS from 6 to 28 diseases

AO for Revised Expanded Newborn Screening Implementation

AO 2012-0154

AO 2014-0045

AO 2020-0052

NBS performed after ___ hours but not later than __ days except for NICU which can be extended for ___ days

24; 3; 7

Any NBS positive reported within ___ hours and NBS negative within __ days

24; 7

Advisory committee on newborn Screening

Chairman:

Number of Members:

Chairman: DOH Secretary

Number of Members: 8

6 IEM tested since 2012

PKU

G6PD

Galactosemia

CAH

Congenital Hypothyroidism

MSUD

Newborn Screening Facility vs Newborn Screening Center

Newborn Screening Facility - Blood Collection

Newborn Screening Center - Blood Testing

NBS

Recall:

Follow up:

Recall: Before testing (locating a newborn that may possibly have a disease)

Follow up: After testing (monitoring a diseased newborn)

NBS Reference Center

UP-NIH

Payment for Expanded NBS

1500

Organ Donation Act of 1991

RA 7170

January 7, 1992

Repealed RA 7885